CN116631552B

CN116631552B - Random grouping scheme generation method, device, equipment and medium

Info

Publication number: CN116631552B
Application number: CN202310905304.1A
Authority: CN
Inventors: 何一纯; 邬疆霖; 刘涛
Original assignee: Zhejiang Taimei Medical Technology Co Ltd
Current assignee: Zhejiang Taimei Medical Technology Co Ltd
Priority date: 2023-07-21
Filing date: 2023-07-21
Publication date: 2023-11-21
Anticipated expiration: 2043-07-21
Also published as: CN116631552A

Abstract

The embodiment of the specification provides a method, a device, equipment and a medium for generating a random grouping scheme. The method comprises the following steps: providing a graphical configuration page, wherein the configuration page is provided with a configuration unit, the configuration unit comprises a stage unit, an experiment group unit and a control group unit, the stage unit is used for representing the experiment stage of the clinical experiment item, and the experiment group unit and the control group unit are respectively used for representing the experiment group and the control group in the experiment stage of the clinical experiment item; and receiving the operation of a user on the configuration unit in the configuration page, and generating and displaying a random grouping scheme of clinical test items, wherein the random grouping scheme comprises a stage unit, and an experiment group unit and a control group unit which are associated with the stage unit. By providing operably added phase units in the graphical configuration page and different phase units corresponding to different test phases, the convenience of the user in configuring the random grouping scheme of clinical test items is improved to a certain extent.

Description

Random grouping scheme generation method, device, equipment and medium

Technical Field

The embodiments in this specification relate to the technical field of computer data processing, and in particular, to a method, an apparatus, a device, and a medium for generating a random grouping scheme.

Background

In clinical trials, randomized groupings of subjects are a very important link. By grouping the subjects, the subjects have equal opportunity to enter the experimental group or the control group, so that clinical curative effects caused by non-drug factors such as diet, rest, self-healing and the like are eliminated, the measured factors of the experimental group and the control group are basically the same, and the mixed interference of the non-drug factors such as the above is reduced, thereby comprehensively evaluating the treatment effect, safety and other properties of the test medicine.

At present, with the rapid development of the clinical trial industry, the clinical trial scale is becoming larger and larger, involving numerous hospitals and massive numbers of subjects. However, in the prior art, a random grouping scheme of subjects is generally designed by respectively entering grouping conditions on a plurality of pages. In the process, a designer needs to newly establish an experimental group on an experimental group page and input a group entering condition of the experimental group, then switch to a control group page to newly establish a control group and input a group entering condition of the control group, and if an input error occurs, a subject has no equal opportunity to enter the experimental group or the control group. In addition, if the clinical test needs two or three randomization or the clinical test needs multiple experimental groups or multiple control groups, the designer needs to repeatedly switch pages for multiple times to newly establish the group entering conditions of each experimental group and control group, which is time-consuming and laborious and also easy to cause contradiction between the group entering conditions of the experimental group and control group, thereby causing the clinical test failure. Thus, this approach to designing a randomized block regimen of subjects has failed to accommodate the evolving needs of the current clinical trial industry.

It can be seen that how to efficiently and accurately design a random grouping scheme of subjects has become an important point in the industry.

Disclosure of Invention

In view of this, various embodiments of the present description are directed to providing a method, apparatus, device, and medium for generating a random grouping scheme, so as to improve the convenience of configuring the random grouping scheme of clinical trial items to a certain extent for a user.

Various embodiments in the present specification provide a method for generating a random grouping scheme, where the method includes: providing a graphical configuration page, wherein the configuration page is provided with a configuration unit, the configuration unit comprises a stage unit, an experiment group unit and a control group unit, the stage unit is used for representing the experiment stage of the clinical experiment item, and the experiment group unit and the control group unit are respectively used for representing an experiment group and a control group in the experiment stage of the clinical experiment item; and receiving the operation of a user on the configuration unit in the configuration page, and generating and displaying a random grouping scheme of the clinical trial items, wherein the random grouping scheme comprises a stage unit, and an experiment group unit and a control group unit which are associated with the stage unit.

One embodiment of the present specification provides an apparatus for generating a random grouping scheme, the apparatus including: the system comprises a providing module, a configuration page and a control module, wherein the providing module is used for providing a graphical configuration page, the configuration page is provided with a configuration unit, the configuration unit comprises a stage unit, an experiment group unit and a control group unit, the stage unit is used for representing an experiment stage of the clinical experiment item, and the experiment group unit and the control group unit are respectively used for representing an experiment group and a control group in the experiment stage of the clinical experiment item; the generation module is used for receiving the operation of a user on the configuration unit in the configuration page, generating and displaying a random grouping scheme of the clinical test items, and the random grouping scheme comprises the stage unit, and an experiment group unit and a control group unit which are associated with the stage unit.

The present description embodiment proposes a computer device comprising a memory storing a computer program and a processor implementing the method according to the above embodiment when the processor executes the computer program.

The present description provides a computer-readable storage medium having stored thereon computer program instructions which, when executed by a processor, implement the method described in the above embodiments.

According to the embodiments provided by the specification, the configuration interface can be provided with the configuration unit by providing the graphical configuration page, the configuration unit can comprise a stage unit for representing the test stage of the clinical test item, and an experiment group unit and a comparison group unit for representing the experiment group and the comparison group in the test stage of the clinical test item, the configuration unit is displayed in the same configuration page, and a random grouping scheme comprising the stage unit, the experiment group unit and the comparison group unit which are associated with the stage unit is generated and displayed under the condition that the operation of a user aiming at the configuration unit in the configuration page is received, so that the convenience of configuring the random grouping scheme of the clinical test item by the user is improved to a certain extent.

Drawings

Fig. 1 is a schematic diagram of a configuration page provided in one embodiment of the present description.

Fig. 2 is a flow chart of a method for generating a random grouping scheme according to an embodiment of the present disclosure.

Fig. 3 is a schematic diagram of a connection relationship between configuration units in a method for generating a random grouping scheme according to an embodiment of the present disclosure.

Fig. 4 is a schematic diagram of a connection relationship between configuration units in a method for generating a random grouping scheme according to an embodiment of the present disclosure.

Fig. 5 is a schematic diagram of a generating device of a random grouping scheme according to an embodiment of the present disclosure.

Fig. 6 is a schematic diagram of a computer device according to an embodiment of the present disclosure.

Detailed Description

In the related art, generation of a randomized block scheme for clinical trials requires designing a randomized block scheme for subjects in such a manner that the block conditions are entered in a plurality of pages, respectively. Specifically, the designer needs to newly establish an experimental group on an experimental group page and input the group entering condition of the experimental group, and then switch to a control group page to newly establish a control group and input the group entering condition of the control group. According to different clinical trial requirements, the multiple pages may have multiple levels, and the user needs to configure the multiple pages in a text mode, so that errors are easy to occur, and configuration items of each page are fixed and single. If the clinical test needs twice randomization or three randomization, or the clinical test needs a plurality of experimental groups or a plurality of control groups, a designer needs to repeatedly switch pages for a plurality of times to newly establish the group entering conditions of each experimental group and the control group, which is time-consuming and labor-consuming, and simultaneously, can easily cause contradiction between the group entering conditions of the experimental group and the control group, thereby causing the clinical test failure. Therefore, the generation of the random grouping scheme of the clinical test items in the related technology may encounter the problems of low input efficiency, insufficient intuitiveness, complicated configuration mode and the like, so that the convenience of configuring the random grouping scheme of the clinical test items by a user is poor.

Therefore, it is necessary to provide a method, an apparatus, a device and a medium for generating a random grouping scheme, by providing a graphical configuration page, the configuration interface may have a configuration unit, the configuration unit may include a stage unit for characterizing a test stage of the clinical test item, and a test group unit and a control group unit for characterizing a test group and a control group in the test stage of the clinical test item, respectively, by displaying the configuration unit in the same configuration page, and generating and displaying a random grouping scheme including the stage unit and the test group unit and the control group unit associated with the stage unit when receiving an operation of a user on the configuration unit in the configuration page, a technical problem of poor convenience in configuring the random grouping scheme of the clinical test item by the user is achieved.

An example of a scenario of application of a generation system for a random grouping scheme of clinical trial projects is provided in this specification.

The system for generating a random grouping scheme of clinical trial items may include a client and a server. The user of the generation system of the randomized block scheme of clinical trial items may be a staff member of the clinical trial field. The user may be involved in a clinical trial program for a certain trial drug. The clinical trial program may have completed the recruitment of subjects. Thus, a user may wish to generate a corresponding random grouping scheme by the generation system of random grouping schemes for the clinical trial items. Further, according to the randomized block scheme, enrolled subjects can be randomized into experimental or control groups indicated by the generation scheme using a lead system to conduct a drug delivery protocol for clinical trials. Further, the efficacy of the test drug can be confirmed according to the response of the test person after taking the drug for subjects in different clinical trial groups. Wherein the subjects in the experimental group can take the test drug and the subjects in the control group can take the placebo.

Specifically, two trial phases are included in a random grouping scheme that a user may wish to configure. Wherein the first trial phase of the time preceding may comprise two queues. The first queue may include 1 experimental group and 1 control group. The second queue may include 2 experimental groups and 1 control group. Wherein the second trial phase at a later time may also comprise two queues. The first queue may include 1 experimental group and 1 control group. The second queue may also include 1 experimental group and 1 control group.

Please refer to fig. 1. The client may present the user with a configuration page of a random grouping scheme of clinical trial items. The configuration page may be used to add configuration units, where the configuration units may include a stage unit, a queue unit, an experiment group unit, and a control group unit. Wherein a phase unit may be used to characterize a trial phase of the clinical trial program. A queue element may be used to characterize a queue within a test phase in the clinical trial program. The experimental and control units may be used to characterize the experimental and control groups, respectively, during the experimental phase of a clinical trial.

Specifically, the configuration page may include a phase addition control for adding a trial phase of a clinical trial project. The user may click on the phase addition control. The client can receive clicking operation of the user on the stage adding control, and generate and display a stage unit of the first test stage in the configuration page. The phase unit is operable to configure a randomized block scheme of subjects participating in the respective trial phase. The phase unit corresponding to the first trial phase may be regarded as the first phase unit.

A queue addition control may be included in the first stage unit for adding a queue within the first trial stage. The user may further click on a queue add control in the first stage element. The client can receive clicking operation of a user on the queue adding control, and a queue unit is generated and displayed in the first stage unit. Wherein the queue element may be nested within the first stage element. The cohort unit may characterize a cohort of subjects participating in the respective trial phase that may be assigned. The queue element is operable to configure a defined condition of a subject entering the queue.

The first queue element may include a group addition control for adding an experimental group or a control group in a queue. The user may further click on a group addition control in the first queue element. And the client can receive clicking operation of the user for the group adding control, and generates an experiment group unit or a comparison group unit in the first queue unit. The experimental group unit may characterize an experimental group within the queue. The experimental group unit is operable to configure the constraints of the subjects entering the experimental group. The control unit may represent a control within the queue. The control unit is also operable to configure the constraints of the subjects entering the control.

Accordingly, the user can operate any one of the stage adding control, the queue adding control and the group adding control for many times, and the client can respond to the operation of the user to generate and display the first stage unit with the completed configuration in the configuration interface. Wherein the first stage unit may comprise a queue unit 1 and a queue unit 2 nested in the first stage unit. Queue element 1 may include 1 experimental group element and 1 control group element nested within queue element 1. Queue element 2 may include 2 experimental groups and 1 control group nested within queue element 2.

Accordingly, the user may generate and present the second stage units corresponding to the second trial stage in accordance with the method described above. Wherein, according to the triggering operation of the user, the second stage unit may include a queue unit 1 and a queue unit 2 nested in the second stage unit, and the queue unit 1 may include 1 experiment group unit and 1 control group unit nested therein. Queue element 2 may also include 1 experimental group element and 1 control group element nested therein.

After the generation stage unit, the queue unit, the test group unit and the comparison group unit in the page are configured, the user can configure the stage unit, the queue unit, the test group unit and the comparison group unit. Specifically, the user may select any configuration unit, and the configuration page may display configuration items of the selected configuration unit. The configuration items may include configuration items defining a group subject condition, a number of subjects in the group, a sex ratio of the subjects in the group, and the like. The user may configure the conditions of the group-entering subjects of the partial configuration unit. The client may generate subject screening criteria according to the user's configuration.

Further, the user can perform an operation of the wiring configuration unit. The user can connect any two units of the stage unit, the queue unit, the experiment group unit or the contrast group unit in the configuration page. Correspondingly, after receiving the connection operation of the user, the client can circulate the subject screening standard in the configuration unit in the connected unit.

Referring to fig. 1, specifically, a user may perform an operation of connecting the queue unit 1 in the first stage unit and the queue unit 2 in the second stage unit, that is, connecting the first stage queue unit 1 and the second stage queue unit 1 in fig. 1. When the user performs the wire connection operation, the starting point of the wire connection operation may be the first stage queue unit 1, and the ending point of the wire connection operation may be the second stage queue unit 1. Accordingly, the client may circulate the subject screening criteria within the first stage queue element 1 towards the second stage queue element 1. That is, the client may copy the subject screening criteria within the first stage queue element 1 to the second stage queue element 1. Wherein the subject screening criteria may indicate entry rules for a subject into the set of subjects represented by the respective configuration unit.

The client side can display a circulation line unit representing the connection operation in a configuration interface when receiving the connection operation of the user. The flow-through line element may be, for example, a graph in the shape of an arrow in fig. 1.

Further, the user may click on the flow line cell. The configuration page may display a subject standard circulation configuration item. The subject standard circulation configuration item may be used to receive a configuration operation to configure subject screening criteria that require circulation, as well as to add subject screening criteria. For example, a user may configure a subject screening criteria for circulation via a subject standard circulation configuration item as a subject's defined condition, which may include that the age of the subject participating in the first trial phase of the second trial phase must be between 20 and 40 years.

After the user completes the configuration of the clinical trial through the graphical configuration page, the configuration completion control may be clicked. The client may send information of the configuration page completed by the user to the server, which may generate a random grouping scheme of the corresponding clinical trial items. Further, the server may randomly assign subjects that have been enrolled to either the experimental or control group indicated by the random grouping regimen via the lead system in accordance with the random grouping regimen of the clinical trial program.

The present description embodiments provide a system for generating a randomized block scheme for clinical trial projects. The system for generating a random grouping scheme of clinical trial items may include a client and a server. The client may be an electronic device with network access capabilities. Specifically, for example, the client may be a desktop computer, a tablet computer, a notebook computer, a smart phone, a digital assistant, a smart wearable device, a shopping guide terminal, a television, a smart speaker, a microphone, and the like. Wherein, intelligent wearable equipment includes but is not limited to intelligent bracelet, intelligent wrist-watch, intelligent glasses, intelligent helmet, intelligent necklace etc.. Alternatively, the client may be software capable of running in the electronic device. The server may be an electronic device with some arithmetic processing capability. Which may have a network communication module, a processor, memory, and the like. Of course, the server may also refer to software running in the electronic device. The server may also be a distributed server, and may be a system having a plurality of processors, memories, network communication modules, etc. operating in concert. Alternatively, the server may be a server cluster formed for several servers. Or, with the development of science and technology, the server may also be a new technical means capable of realizing the corresponding functions of the embodiment of the specification. For example, a new form of "server" based on quantum computing implementation may be possible.

Referring to fig. 2, an embodiment of the present disclosure provides a method for generating a random grouping scheme. The method for generating the random grouping scheme can be applied to the client. The method of generating the random grouping scheme may include the following steps.

Step S110: providing a graphical configuration page, wherein the configuration page is provided with a configuration unit, the configuration unit comprises a stage unit, an experiment group unit and a control group unit, the stage unit is used for representing the experiment stage of the clinical experiment item, and the experiment group unit and the control group unit are respectively used for representing the experiment group and the control group in the experiment stage of the clinical experiment item.

In some cases, the construction of a random grouping scheme for clinical trial projects in the related art requires filling in configuration by text information in a configuration system. Moreover, different test phases, different queues, different test groups and control groups for clinical test items all need to be configured on different pages. Therefore, in the related art, the construction of a random grouping scheme of clinical trial projects is complicated and the construction efficiency is low. Therefore, by providing the graphical configuration page, the configuration can be carried out on a plurality of items in a test stage, a queue, an experimental group or a comparison group in the clinical test in the same configuration page, and the convenience and the efficiency of configuring the random grouping scheme by a user are improved. Meanwhile, in the related art, a random grouping scheme configured in a text form is difficult to intuitively display the random grouping scheme configured in an integral way for a user. The user may have no intuitive concept of the overall random grouping scheme after completing the configuration. Therefore, through the graphical configuration page, a framework of a random grouping scheme of clinical test items can be intuitively displayed for a user.

During the development of clinical trial projects, subjects participating in the clinical trial need to be enrolled. The subject may have a person with an indication associated with the subject of the clinical trial program. Wherein, the test object can be a medicine or a medical instrument. After recruitment to subjects, workers may be required to design a randomized cohort regimen for the subjects. After the random grouping regimen design is completed, the enrolled subjects may be randomly assigned to either the experimental or control group based on the rules determined by the random grouping regimen. Further, different test means may be employed for the test subjects for different experimental groups or control groups. For the drug, the subjects in the experimental group may take the test drug, and the control group may be multiplexed with the placebo, and the effect of the test drug may be determined by detecting the response of the person after taking the drug for the subjects. Similar means may be employed for medical devices. In some embodiments, a clinical trial may require multiple trial phases. Multiple experimental groups or control groups can be designed for different test stages to perfect the test results of clinical tests. Thus, the randomized block scheme of clinical trial items can be used to divide subjects into different experimental or control groups to employ different trial means for the experimental or control group subjects to obtain the trial results of the clinical trial.

In this embodiment, the configuration page may be used to configure a randomized block scheme of clinical trial items. In particular, the configuration page may be a graphical configuration page. The configuration page may include a configuration unit. The configuration page is operable to add configuration elements. The configuration unit may include a stage unit, an experimental group unit, a control group unit, or the like. Accordingly, the user may operatively add a phase unit corresponding to a trial phase of a clinical trial item in the configuration page. Of course, the user may also operatively add an experimental group unit characterizing an experimental group and a control group unit characterizing a control group in the configuration page.

In this embodiment, the configuration unit may be used to characterize a test phase, a cohort, a test group, a control group, or the like to which a subject enrolled in a clinical test project may be assigned. The newly created configuration unit may characterize the test phase, cohort, test group, control group, etc. that a subject may enter. The configuration unit may be configured with subject screening criteria, which may represent entry rules that the subject needs to follow when entering the trial phase, cohort, trial group, or control group represented by the configuration unit. The subject screening criteria may include a defined condition that a subject who is able to enter a corresponding test phase, cohort, experimental group, or control group needs to meet.

In this embodiment, the configuration unit may include a stage unit, an experiment group unit, a control group unit, a queue unit, and the like. The phase unit may be a graphic control in the configuration page representing the corresponding test phase. The graphical control may be triggered to configure a random grouping scheme of subjects for the respective trial phase. The stage units can be displayed in any graph such as a circle, a square and the like in the configuration page, and the embodiment of the present disclosure is not limited herein.

In this embodiment, the phase unit may characterize a test phase in a clinical trial. In some embodiments, the phase unit may be used to configure the design of the trial phase. In particular, a stage unit may be used to configure subject screening criteria that can participate in the trial stage to which the stage unit corresponds. Subjects meeting the subject screening criteria may enter the corresponding trial phase in accordance with the entry rules indicated by the subject screening criteria. For example, a phase unit may define a subject entering a test phase by configuring the number of cohorts, experimental groups, control groups within the test phase. Alternatively, the phase unit may be used to configure the number of subjects included in the cohort, the experimental group, the control group, and the trial phase. In some embodiments, the stage unit may also define the configuration items of the queue, the experimental group, and the control group in the experimental stage as a whole.

In this embodiment, the clinical trial may include an experimental or control group. The configuration page is operable to add experimental group elements and control group elements. The experimental set unit and the control set unit may be used to characterize an experimental set and a control set, respectively, during a test phase in the clinical trial program.

In this embodiment, the experimental group or control group may represent a collection of subjects receiving the same test regimen. The test group may be a group of subjects who receive a test drug, a test diagnostic method, or a test medical device. The control group may represent a subject group receiving standard treatment or placebo for use as a control for the experimental group. According to the requirements of different clinical tests, different numbers of test groups, control groups and the like can be configured in the test stage so as to evaluate the effects of test medicines, test diagnosis and treatment methods or test medical instruments according to test results fed back by a subject.

In some embodiments, both the experimental and control groups can be configured for different experimental phases. Accordingly, the phase unit is operable to add an experimental group unit corresponding to an experimental group or a control group unit corresponding to a control group. By adding the experiment group unit and the control group unit in the stage unit, a user can conveniently configure the experiment groups or the control groups corresponding to different experiment stages so as to form a random grouping scheme of the corresponding experiment stages. In addition, the experiment group unit and the comparison group unit can be displayed in the stage unit, compared with the prior art that a random grouping scheme is configured in a plurality of pages by means of filling characters, the comparison group unit or the experiment group unit is added in the stage unit, so that a user can intuitively know an experiment group or a comparison group included in each experiment stage, the random grouping scheme of the configured corresponding experiment stage is adaptively adjusted, and the user can conveniently develop a grouping flow of a clinical experiment.

In this embodiment, the experimental group unit or the control group unit may be a graphical control used for configuring the experimental group or the control group in the configuration interface. The experimental or control set of cells may be of any shape and color, respectively. The shape or color of the experimental group unit or the control group unit may be the same as or different from the stage unit. The colors and shapes may be the same or different between the different experimental or control set units. The present embodiment is not limited to this.

In some embodiments, the experimental set unit may also be used to configure the design of the experimental set. Wherein the experimental group unit can be configured with corresponding subject screening criteria. The subject screening criteria for a panel of units may include a definition of subjects that can enter the panel to which the panel of units corresponds. The control unit may be used to configure a control design. Wherein, the control group unit can also be configured with corresponding subject screening criteria. The subject screening criteria for a control group may include a defined condition of subjects that can participate in the control group to which the control group unit corresponds. Specifically, for example, the experimental group unit or the control group unit may be used to configure the number of subjects, the sex ratio of the subjects, and the like in the corresponding experimental group or control group. Depending on the user's configuration of the experimental or control unit, an experimental or control design including subject screening criteria may be generated.

Step S120: and receiving the operation of a user on the configuration unit in the configuration page, and generating and displaying a random grouping scheme of the clinical trial items, wherein the random grouping scheme comprises a stage unit, and an experiment group unit and a control group unit which are associated with the stage unit.

In some cases, a user may operate on configuration units in a configuration page to generate a random grouping scheme of the clinical trial items. The user operation may include adding a graphical stage unit, a queue unit, an experiment group unit, or a control group unit to a configuration page. Therefore, by operating in the graphical configuration page, the convenience of operation of the user can be improved to a certain extent.

In this embodiment, the user operation may be a configuration operation for a configuration unit. Specifically, the configuration operation may be a configuration operation for a stage unit, or a configuration operation for a queue unit included in the stage unit, or a configuration operation for a control unit, or a configuration operation for an experiment unit. The configuration operation may include, but is not limited to, a new operation, a drag operation, a copy operation, a delete operation, an operation to configure a configuration item, and the like for the configuration unit. The user operation can be executed on a personal computer end or a mobile terminal. The user operation is not limited to clicking, long pressing, double clicking, sliding and other operation modes.

In this embodiment, the client may generate and present the random grouping scheme. Wherein the random grouping scheme may include a phase unit, and an experimental group unit and a control group unit associated with the phase unit. Specifically, the configuration page may graphically display a phase unit, an experiment group unit and a control group unit associated with the phase unit, and an association relationship between the two. The association relationship may include that an experimental group corresponding to an experimental group unit belongs to an experimental stage represented by the stage unit, and a control group corresponding to a control group unit belongs to an experimental stage represented by the stage unit. In some embodiments, the association may be represented by a nesting between configuration units. For example, a corresponding experimental group unit belonging to an experimental group of a certain experimental stage may be nested in a stage unit characterizing the corresponding experimental stage. Of course, the association relationship may also be represented by the same color, or by using the same graphic to represent the associated stage unit, control unit, or experimental unit.

In this embodiment, the receiving the operation of the user on the configuration unit in the configuration page may generate and display a random grouping scheme of the clinical test items, and may configure a test stage, a queue in the test stage, and an experiment group or a control group in the queue for generating the clinical test items according to the operation of the user on the configuration unit, so as to form the random grouping scheme of the clinical test items. Of course, the operation of the user on the configuration unit may be sent to the server, and the random grouping scheme of the clinical trial items may be generated through the server, so as to feed back to the client. For example, the client may send configuration information of the user for the patterned configuration page to the server in a data of a specified format, and the server may invoke an interface of a configuration system of the clinical trial item to implement generation of the random grouping scheme. In some embodiments, the configuration page may also be used to characterize a randomized block scheme of the clinical trial items. The generation of the randomized block scheme for clinical trial items may be accomplished by a user's validation of the randomized block scheme for clinical trial items.

In some embodiments, the step of receiving a random grouping scheme of the clinical trial items generated and presented by a user for operation of the configuration unit within the configuration page comprises: receiving operation of newly-built stage units in the configuration page by a user; receiving operation of a user for newly creating an experiment group unit and a control group unit in a newly created stage unit, wherein the experiment group unit and the control group unit are nested in the stage unit; generating a random grouping scheme of the clinical trial items based on the newly created phase unit and the experimental group unit and the control group unit nested within the phase unit; a random grouping scheme of the generated clinical trial items is presented on the configuration page.

In some cases, there is an association between the trial phases in the clinical trial project represented by the phase units, the trial group units represented by the trial group units, and the control group represented by the control group units. The association may indicate that the experimental group and the control group belong to the respective test phases. By embedding the experiment group unit and the control group unit which are related to the stage unit in the stage unit, the related relationship can be intuitively displayed in a configuration page, and the convenience of the random grouping scheme configuration of the clinical trial is improved to a certain extent.

Referring to fig. 1, the experimental group unit and the control group unit associated with the stage unit are nested in the stage unit, which may represent the display areas of the experimental group unit and the control group unit in the configuration page, and are included in the display areas of the stage unit.

In this embodiment, a new phase unit may be added to the configuration page. Specifically, a stage addition control may be provided in the configuration page for creating a stage unit. Correspondingly, the method for receiving the operation of the newly-built stage unit in the configuration page by the user is that the operation of triggering the stage adding control is received. Of course, the option of newly-built phase unit can also be provided in the right-click menu in the configuration page, and correspondingly, the method for receiving the operation of the newly-built phase unit in the configuration page by the user can be triggered by receiving the option of newly-built phase unit in the right-click menu.

In this embodiment, an experimental group unit or a control group unit may be added to the stage unit. Specifically, a group adding control may be provided in the stage unit, for creating an experimental group unit or a control group unit in the stage unit. The group adding control can refer to two controls, namely a control group adding control and an experimental group adding control. Correspondingly, a control group adding control and an experimental group adding control can be displayed in the stage unit. The method for receiving the operation of the newly-built experiment group unit and the contrast group unit in the newly-built stage unit by the user can be that the client identifies that the contrast group adding control and the experiment group adding control in the newly-built stage unit are triggered. In some embodiments, the group addition control may be a control, and upon triggering of the control, a menu may be presented that provides the user with the option to add experimental or control group elements. The user can select in the menu that all the experimental group units, the control group units, or the specified number of experimental group units and control group units are to be added at the same time.

In this embodiment, the experimental and control set units may be nested within the phase unit, such that the expression experimental and control set units characterize the experimental and control set within the experimental phase represented by the phase unit. That is, the display area of the experimental and control group units in the configuration page may be included within the display area of the stage unit. Further, a random grouping scheme of the clinical trial items may be generated based on the newly created phase units and the experimental and control group units nested within the phase units. The random grouping scheme may include a trial phase represented by a phase unit, and a control group and a trial group within the trial phase represented by a control group unit and a trial group unit. After generating the randomized block arrangement of clinical trial items, the generated randomized block arrangement of clinical trial items can be presented in the configuration page.

In some embodiments, the method for generating a random grouping scheme may further include: receiving the operation of dragging the experimental group unit and/or the control group unit by a user; and adjusting the position of the experimental group and/or the control group in the stage unit based on the end point of the dragging action.

In some cases, the experimental unit and/or the control unit may be dragged to adjust the position of the experimental unit and/or the control unit within the configuration unit, so that the experimental unit and/or the control unit may be flexibly and conveniently adjusted.

In some embodiments, the drag action may be used to adjust the nesting relationship of the experimental and/or control group units nested within one configuration unit to migrate into another configuration unit. And determining the configuration unit where the dragged experimental group unit and/or the control group unit are finally positioned according to the ending point of the dragging action. For example, in the configuration page, the first stage unit may include a queue unit 1 and a queue unit 2, and the drag operation may drag the experiment group unit in the queue unit 1 into the queue unit 2. After dragging, the experimental group unit in the queue unit 1 is transferred into the queue unit 2. Of course, the drag operation may drag the experiment group unit under the queue unit 1 into the first stage unit, the second stage unit, or the queue unit under the second stage unit.

In some embodiments, the drag action may also be used to replicate the experimental or control set of cells. And pasting the copied experimental group unit and the control group unit into the configuration unit indicated by the end point through a drag operation. When a user needs to configure a plurality of similar configuration units, repeated configuration of the experimental group units and/or the control group units can be avoided to a certain extent, and the configuration efficiency of the user can be improved. The dragging action for copying the experimental group unit or the control group unit and the dragging action for adjusting the nesting relationship can be distinguished in combination with other operations. For example, a drag action for copying an experimental group unit or a control group unit may be effective when the ctrl key is pressed.

In some embodiments, the drag action may also be used only to adjust the position of the experimental and/or control units in the same configuration unit. For example, the sequencing of the experimental and/or control group units in the same configuration unit may be adjusted.

In this embodiment, the client may receive an operation of the user dragging the experiment group unit and/or the control group unit. The operation of the user dragging the experimental group unit and/or the control group unit can be used for adjusting the position of the experimental group unit and/or the control group unit in the stage unit. Specifically, based on the end point of the drag action, the experimental group unit and/or the control group unit may be transferred into the stage unit corresponding to the end point, or the experimental group unit and/or the control group unit may be copied into the stage unit corresponding to the end point. For example, the experimental and/or control set of cells that are dragged are within the first stage cell. The location of the end point may be within the second stage unit. Accordingly, the experimental and/or control set of cells may be transferred or copied into the second stage cell.

In some embodiments, the configuration unit may further include a queue unit; after the step of the receiving user creating the operation of the phase unit in the configuration page, before the step of the receiving user creating the operation of the experiment group unit and the contrast group unit in the created phase unit, the method further includes: receiving operation of a user for newly creating a queue unit in a newly created stage unit, wherein the queue unit is nested in the stage unit; the step of receiving the operation of the user for newly creating the experimental group unit and the control group unit in the newly created stage unit specifically comprises the following steps: and receiving operation of a user for newly creating an experiment group unit and a control group unit in the newly created queue unit, wherein the experiment group unit and the control group unit are nested in the queue unit.

In some cases, multiple queues may be included within the trial phase of a clinical trial program. Further, the queue may include an experimental group or a control group. Thus, the randomized block scheme of clinical trials can be more complex and variable. Accordingly, in the random grouping scheme of clinical trial items provided by the embodiments of the present disclosure, the phase unit is operable to add a queue unit of a queue, and the queue unit is operable to add a trial group unit or a control group unit. By adding the queue unit in the stage unit and adding the experiment group unit or the comparison group unit in the queue unit, the queue unit is nested in the stage unit for display, and the experiment group and the comparison group can be nested in the queue unit, so that a user can conveniently configure the experiment group or the comparison group in each queue of each experiment stage to form a random grouping scheme of the corresponding experiment stage. Compared with the related art, at least part of items in the test stage, the queue and the test group or the comparison group need to be configured in different pages, the embodiment of the specification can not only conveniently configure the random grouping scheme in the same configuration page through a graphical operation mode, but also more intuitively display the random grouping scheme of the more complex clinical test to a user, so that the user can conveniently and adaptively adjust according to the random grouping scheme of the corresponding test stage which is already configured, and the user can conveniently develop the grouping flow of the clinical test.

In this embodiment, the cohort within the trial phase of the clinical trial program may represent a collection of subjects having the same indication, taking the same medication, or using the same treatment regimen. In some embodiments, the development of a clinical trial may involve multiple centers and the enrolled subjects may originate from different centers. Accordingly, a cohort of clinical trials may represent a collection of subjects of different origin. In particular, the queues of different clinical trials may correspond to different centers. Multiple experimental or control groups may be included for each queue.

In this embodiment, the queue element may characterize a queue within a respective test phase. The queue elements corresponding to different queues may be different. In particular, the queue element may be a graphical control in a configuration interface for configuring a queue. The queue element may be of any shape and color. The shape or color of the queue element may be the same as or different from the phase element, the experiment group element or the control group element. The color and shape may be the same or different between different queue elements. The present embodiment is not limited to this. In addition, the queue unit may display the corresponding stage unit to indicate the test stage of the clinical test item to which the queue corresponding to the queue unit belongs. Through the position relation displayed by the stage unit and the queue unit in the configuration unit, the whole random grouping scheme can be intuitively displayed for the user. Meanwhile, the method is also convenient for the user to carry out adaptive adjustment according to the configured overall random grouping scheme and is convenient for the user to develop the grouping flow of the clinical test.

In some embodiments, the queue element may be used to configure a design of a queue. In particular, the queue element can be configured with corresponding subject screening criteria. Wherein the subject screening criteria may include a definition of a set of subjects that can be formed by subjects entering the cohort corresponding to the cohort unit. Specifically, for example, the defined conditions may be for the number of subjects in the cohort, the sex ratio of the subjects. Alternatively, the cohort unit may be configured to receive only subjects less than 30 years of age, or the cohort unit may include no more than 3 experimental or control group units.

In some embodiments, the phase units, queue units, experimental group units, and control group units that are interrelated may have multiple nested relationships. Specifically, the experimental group unit and the control group unit may be nested in the queue unit, that is, the experimental group unit and the control group unit may be displayed in the queue unit, so as to indicate the queue to which the experimental group or the control group corresponding to the experimental group unit or the control group unit belongs. The queue elements may be nested within the phase elements, i.e. the queue elements may be presented within the respective phase elements. Through the queue unit comprising the experiment group unit and the control group unit and the stage unit comprising the queue unit, the random grouping scheme of the clinical test can be intuitively displayed for the user, and the efficiency of configuring the random grouping scheme of the clinical test item by the user is improved. Wherein the cohort unit comprises a cohort that can be used to indicate an experimental or control group to which subjects divided into the respective cohorts can be assigned. After configuring the completion queue or experimental or control group, the configuration of the random grouping scheme of the corresponding trial phase may be further completed to form a random grouping scheme of the clinical trial items.

In this embodiment, the phase unit may include a queue adding control for creating a phase unit. The method for receiving the operation of the user for newly creating the queue unit in the newly created stage unit can be that the client receives that the queue adding control in the stage unit is triggered. Accordingly, the client may generate and present the newly created queue element within the phase element. Wherein the queue element is nested within the stage element.

Accordingly, the queue unit may include the group adding control therein for adding the experimental group unit or the control group unit in the queue unit. The operation of the receiving user to newly establish the experiment group unit and the comparison group unit in the newly established queue unit may be that the group adding control in the received queue unit is triggered. Correspondingly, the client can generate and display a newly-built experimental group unit or a comparison group unit in the queue unit. Wherein the experimental group unit and the control group unit are nested in the queue unit.

In some embodiments, when there are a plurality of queue elements within the phase element, the method of generating a random grouping scheme for the clinical trial items further comprises: receiving an operation of dragging the queue unit by a user; and adjusting the plurality of queue units based on the end point of the drag action, and positioning in the stage units.

In some cases, the drag action may also be for a queue element. In some embodiments, the drag action may be used to adjust the position of the queue element within the same configuration element. Of course, the drag action may also be used to adjust the queue element into other configuration elements. Alternatively, the drag action may be used to copy the queue element into a designated configuration element.

In some embodiments, the method of generating a random grouping scheme for clinical trial items may further comprise: receiving operation of connecting the configuration units by a user, wherein the connection operation aims at any two units of a stage unit, a queue unit, an experiment group unit and a comparison group unit in the same configuration unit; based on the wiring operation, subject screening criteria in the connected configuration units are circulated in the connected units.

In some cases, there may be a person flow between subjects in different trial phases, cohorts, trial groups, and control groups in a randomized group regimen of clinical trial projects. In particular, for example, the test results of the second test phase may be complementary to those of the first test phase. Thus, the subject of the second trial phase may be derived from the first trial phase. By assigning at least part of the subjects participating in the first trial phase to the second trial phase, the second trial phase may be further targeted according to the trial results of the first trial phase. In the related art, as the information of the test stage is required to be input into the page of the test stage, the information of the queue to be established is input into the page of the configuration queue, the information of the clinical test is input into the page of the configuration experiment group or the comparison group, and the configuration rules of the flow of the personnel of the subjects are required to be manually controlled, so that the configuration of the personnel flow direction relationship among the collection of the subjects in different test stages is difficult to realize. Therefore, in the embodiment of the specification, the screening rule of the subjects in the configuration unit is synchronized to the connected unit by the operation of the user connection in the graphical configuration page, namely, the screening rule of the subjects entering the test stage, the queue, the control group or the experimental group is circulated in the connected unit, so that the configuration efficiency of the random grouping scheme of the user for the clinical test items can be improved to a certain extent. Meanwhile, a random grouping scheme of the clinical test required by the personnel flow of the configured subjects can be displayed for the user more intuitively, so that the user can adjust the random grouping scheme adaptively and can develop a grouping flow of the clinical test conveniently.

In some implementations, the configuration page can include a flowline cell add control. The flow-through wire unit may be used to indicate a wire operation. The operation process of the configuration unit for connecting the user received by the client side can be that the user clicks the flow line unit adding control, and the configuration page enters a connection mode. Then, the user may click on the first configuration unit and then click on the second configuration unit to characterize that the two configuration units are connected. The client may receive a user's connection operation for two configuration units, circulate subject screening criteria within the connected configuration units within the connected units.

In some embodiments, each configuration unit may include a trigger area for the connection operation, and the user may click on the trigger area, and in a case where the client identifies that the trigger area of the first configuration unit is clicked for a specified time after the client identifies that the trigger area of the second configuration unit is also clicked, the client may consider that the two configuration units are connected.

During the randomization of enrolled subjects into groups, subjects may be assigned to different trial phases, cohorts, experimental groups, or control groups. The trial phase, cohort, trial group, or control group in the randomized block regimen can be configured with subject screening criteria during which subjects are assigned. The subject screening criteria may include an entry condition that the subject needs to meet. The subject can enter the corresponding test phase, cohort, experimental group or control group only if the entry condition is met. In this embodiment, the subject screening criteria may represent an entry rule for a subject configured for the configuration unit. Specifically, for at least some of the terms in the phase unit, the cohort unit, the experimental group unit, or the control group unit, a corresponding subject screening criteria may be configured. In the subject's enrollment phase, the subject is required to enter the trial phase, cohort, trial or control group according to the subject screening criteria. Wherein the subjects in the trial phase, cohort, trial group or control group meet the subject screening criteria.

In some embodiments, the subject screening criteria may indicate a defined condition of a subject that can enter a test phase, cohort, test group, or control group. For example, the limitation may be that the subject cannot be older than 30 years old, or that the subject has no heart disease, etc. Of course, the limitation may also be a limit on the number of subjects entered. For example, for a phase unit, the defined condition may be that the number of subjects in the trial phase does not exceed 300. Alternatively, for a cohort unit, the qualifying condition may be that the average age of the subjects in the cohort is no greater than 40 years old, and so on. The subject only has the opportunity to enter the corresponding test phase, cohort, experimental group or control group if the defined condition is met.

In some embodiments, the subject screening criteria may also represent rules of subject personnel flow configured for the configuration unit. The subject entering the configuration unit may be defined by rules of the flow direction of the subject's personnel. In particular, the subject screening criteria may indicate the source of the subject entering a certain configuration unit and the subject's constraints. For example, the subject screening criteria of the second stage unit may be configured such that a subject participating in a second trial stage corresponding to the second stage unit is required to participate in the first trial stage. Alternatively, the subject screening criteria of the second stage unit may be configured such that subjects participating in a second trial stage corresponding to the second stage unit need to be subjects in a specified cohort, a specified trial group, or a specified control group in a first trial stage that is immediately prior. In some embodiments, the rules of personnel flow direction may also include subject entry conditions, exit conditions, and the like.

In some embodiments, the subject screening criteria may also represent rules for indicating the priority of a subject to enter a corresponding configuration unit. For example, queue element 1 and queue element 2, which are in the same stage element. Queue element 1 has a higher priority than queue element 2. Corresponding to the above. Subjects entering the trial phase corresponding to that phase unit may enter the queue unit 1 preferentially.

After receiving operation of the user connecting the configuration unit, the client may circulate at least part of the subject screening criteria within the connected configuration unit within the connected unit. Specifically, circulating the subject screening criteria within the connected configuration units within the connected units may mean synchronizing or replicating the subject screening criteria within the configuration units between the connected configuration units, avoiding duplication of configuration to some extent, and improving the efficiency of a user configuring a randomized block scheme of clinical trial items. Specifically, for example, after the configuration unit 1 completes the subject screening criteria, the configuration unit 1 may be wired with the configuration unit 2. Accordingly, at least part of the subject screening criteria of configuration unit 1 may be copied to configuration unit 2. In the subject randomization phase, subject data representing a subject may determine a configuration unit into which subject data can be assigned in accordance with the subject screening criteria of configuration unit 1 in the randomization protocol, and the subject screening criteria of configuration unit 2 replicated from configuration unit 1.

In addition, in the related art, a random grouping scheme of clinical test projects needs to newly establish grouping conditions of each round of test groups and control groups in different pages, and when the clinical test projects are very complex, the grouping conditions are likely to have contradiction, so that the clinical test group entering failure is caused. For example, a clinical trial may include a first trial phase and a second trial phase, which may be complementary to the first trial phase, performed in accordance with a time schedule. Therefore, the group entering condition of the experimental group in the second test stage cannot be completely contradicted with the group entering condition of the experimental group in the first test stage, otherwise, no subject enters the experimental group in the second test stage, so that the clinical test is failed to develop. Thus, at least part of the subject screening criteria in the connected configuration units may be circulated in the connected units by connecting the configuration units. In some embodiments, the user can further configure the subject screening criteria of the subject based on the circulating subject screening criteria according to the requirements of the clinical trial, so that contradiction of rules among configuration units can be better avoided, and the success rate of the clinical trial into the group is improved.

In some embodiments, the configuration units have a nested relationship therebetween. Accordingly, subject screening criteria between configuration units having nested relationships may have corresponding hierarchical relationships. For example, queue element 1 is nested within a first stage element. Accordingly, the subject screening criteria configured in the first stage unit may define that the age of the subject capable of entering the corresponding trial stage does not exceed 30 years. Based on this, the subject screening criteria configured in the cohort unit within the first-stage unit may be synchronized to the age of the subject entering the corresponding cohort, nor may it be further defined that the age of the subject entering the corresponding cohort is greater than 30 years old, nor is it greater than 20 years old. That is, the subject screening criteria for a configuration unit at a lower level of nesting relationship should be met for a configuration unit at an upper level of nesting relationship.

In this embodiment, the connection operation may be directed to any two units of a stage unit, a queue unit, an experiment group unit, and a control group unit in the same configuration unit. Specifically, any connection may be performed for the stage unit, the queue unit, the experiment group unit, and the control group unit in the same configuration unit. Subject screening criteria between connected units may be communicated. The same configuration unit may be a phase unit, a queue unit, or the like.

Specifically, for example, the first stage unit may include therein a queue unit 1 and a queue unit 2. Queue element 1 may include 1 experimental group element and 1 control group element. Queue element 2 can include 2 experimental group elements and 1 control group element.

Referring to fig. 3, the user connection may be an experiment group and a control group in the queue unit 1 and the queue unit 2 in the first stage unit, and in the queue unit 1 in the second stage unit. Wherein the experimental group unit and the control group unit in the queue unit 1 in the second stage unit can be connected through a unidirectional arrow, and the subject screening standard indicating the experimental group unit is copied to the control group unit. Wherein queue element 1 and queue element 2 can be connected by means of a double arrow. The double-headed arrow may be a flow-through line element representing a double-headed connection relationship. I.e. the subject screening criteria may be circulated bi-directionally prior to the two queue elements. In particular, for example, subject screening criteria may be shared between two queue elements of the first stage. All the subject screening criteria of the queue units can be shared among the queue units or part of the subject screening criteria through user configuration operation.

Of course, the user connection may be an experiment group unit and a control group unit in the queue unit 1. Alternatively, the subscriber line may be a group of units in the queue unit 1 in the first stage unit and the queue unit 2 in the first stage unit.

In some embodiments, when the configuration unit is plural, the method for generating the random grouping scheme may further include: receiving operation of connecting the configuration units by a user, wherein the connection operation aims at any two different configuration units; based on the wiring operation, subject screening criteria in the connected configuration units are circulated in the connected units.

In some cases, a user may wire any two configuration units in a configuration page. Accordingly, subject screening criteria within the connected configuration units may be circulated.

Any two configuration units aimed by a user can be any two units of a stage unit, a queue unit, an experiment group unit and a control group unit in the same configuration unit. Or any two units within a different configuration unit. Any two units can be any one of a stage unit and a queue unit, an experimental group unit or a control group unit, and can also be any one of a queue unit and an experimental group unit or a control group unit. Of course, any two units may be directed to different stage units and queue units, experimental group units, or control group units.

Specifically, for example, referring to fig. 4, the arrows on the lines may represent the flow-through cells. The configuration unit of the user connection line may include: and a circulation line unit 10 for connecting the experimental group unit in the queue unit 1 of the first stage unit and the experimental group unit in the queue unit 1 of the second stage unit, and for copying the subject screening standard of the experimental group unit in the first stage unit to the experimental group unit of the second stage unit.

And a circulation line unit 20 for connecting the control group unit in the queue unit 1 of the first stage unit and the queue unit 1 of the second stage unit, and for copying the subject screening standard of the control group unit in the first stage unit to the queue unit 1 of the second stage unit.

And a circulation line unit 30 for connecting the first stage queue unit 1 and the experimental group unit in the first stage queue unit 2, and for bidirectionally circulating the subject screening criteria of the first stage queue unit 1 with the subject screening criteria of the experimental group unit 1 in the first stage queue unit 2. In particular, the panel units 1 of the first stage unit and the panel unit 1 within the panel unit 2 of the first stage unit may have shared subject screening criteria.

A flow-through line unit 40 for connecting the first stage unit and the queue unit 2 in the second stage unit, and for bi-directionally synchronizing the subject screening criteria of the first stage unit with the subject screening criteria of the queue unit 2 of the first stage unit.

And a circulation line unit 50 for connecting the control group unit in the queue unit 2 of the second stage unit and the experiment group unit 2 in the queue unit 2 of the first stage unit, and for copying the subject screening standard of the control group unit in the queue unit 2 of the second stage unit to the experiment group unit 2 in the queue unit 2 of the first stage unit.

In some embodiments, the step of communicating the subject screening criteria within the connected configuration units within the connected units based on the wiring operation comprises: and circulating the subject screening standard in the unit positioned at the starting point towards the unit positioned at the ending point based on the starting point and the ending point of the connecting line operation.

In some cases, there may be some variance in the condition of the subject's inclusion between the experimental or control groups in a randomized block regimen of clinical trial projects. For example, a first trial phase may be a time-preceding trial phase and a second trial phase may be a time-following trial phase, the subject participating in the second trial phase may need to further meet the requirements of the second trial phase in case the requirements of the subject of the first phase are met. Thus, the subject screening criteria within one configuration unit may be a further refinement of the subject screening criteria within another configuration unit, or may be appropriately adjusted based on the subject screening criteria within another configuration unit. Thus, the link operation may have a direction to circulate in-cell subject screening criteria at a start point toward a cell at an end point based on the start point and the end point of the link operation.

In this embodiment, circulating the in-cell subject screening criteria at the starting point toward the cell at the ending point may represent copying the in-cell subject screening criteria at the starting point to the configuration cell at the ending point. Accordingly, the in-cell subject screening criteria for the end point configuration may include in-cell subject screening criteria for the start point configuration. In some embodiments, the user may adjust or refine the subject screening criteria within the configuration unit of the endpoint. In some embodiments, for a wired operation with a direction, the subject screening criteria of the configuration unit of the starting point may be synchronized to the configuration unit of the ending point after the change, while the subject screening criteria of the configuration unit of the ending point may not be synchronized to the configuration unit of the starting point after the change.

The generation method of the random grouping of the clinical trial items can be adjusted more flexibly through the connection operation with the direction. And the configuration unit of the end point can be adaptively adjusted on the basis of the circulation of the screening standard of the subject according to the requirement of the clinical test, so that the possibility of contradiction of the screening standard of the subject caused by more connection relations can be avoided to a certain extent.

In some embodiments, after the step of receiving the operation of connecting the plurality of queue units to the user, the method for generating a random packet scheme may further include: and forming a flow line unit between the connected units based on the connection operation.

In some cases, after the user completes the connection operation with respect to the configuration unit, the client may form a flow-through line unit between the connected units based on the connection operation. Through showing the circulation line units in the configuration page, the circulation relation of the subject screening standard among the plurality of configuration units can be intuitively shown for the user. And the distribution line unit is also convenient for a user to configure the contents such as the screening standard, the flow direction and the like of the subject to be distributed in the distribution line unit.

In some embodiments, the flow line unit may be a graphical control in the configuration interface for connecting any two configuration units. The flow cell may be of any shape and color. In particular, for example, the flow line element may be a graphic control in the shape of an arrow. Alternatively, the flow-through line element may be a matrix-shaped graphical control. The present embodiment is not limited to this. In the configuration page, the flow line units may graphically connect the configuration units to indicate subject screening criteria flow between the connected configuration units. Through the graphical connection mode, the circulation relation of the subject screening standard among the configuration units can be intuitively represented, and a random grouping scheme of clinical test projects can be conveniently developed or adjusted by a user.

In some embodiments, the user's wiring may have a direction, and accordingly, the flow-through wiring unit may also be capable of indicating a graphical representation of the direction. For example, a standard bi-directional flow-through line for a subject is screened, and flow-through line units may be represented by bi-directional arrows. Standard unidirectional flow lines are screened for subjects, and flow line units can be represented by unidirectional arrows.

The subject screening criteria of different configuration units can be duplicated for circulation through the circulation line unit. Accordingly, in the course of grouping already recruited subjects according to the randomized block scheme of the constructed clinical trial project, the guidance system can automatically randomize subject data representing the subjects into groups according to rules indicated by subject screening criteria, or automatically associate subjects within the configuration unit to which the flow-through line unit is connected, which can improve reliability of the randomized block scheme design of the clinical trial project to some extent, and improve efficiency of the grouping of subjects.

In some embodiments, based on the wiring operation, the step of communicating the subject screening criteria within the connected configuration unit within the connected unit may include: receiving an operation of configuring the circulation line unit by a user; displaying a standard flow configuration item for the flow line unit; receiving the operation of a user aiming at the standard circulation configuration item, and confirming the circulation strategy of the subject screening standard carried by the circulation line unit; and circulating the subject screening standard corresponding to the circulation strategy in the connected unit.

In some cases, the flow-through strategy of subject screening criteria may be different between different configuration units. Specifically, for example, some configuration units may only need to circulate a part of the subject screening criteria, or further increase the subject screening criteria based on a part of circulation, etc. Therefore, by triggering the circulation line unit, the configuration page can display the standard circulation configuration item for confirming the circulation strategy of the subject screening standard carried by the circulation line unit, so that the convenience of configuring the circulation strategy of the subject screening standard by a user is improved.

In some embodiments, the flow-through line unit may be triggered by a designated operation to enable configuration of subject screening criteria requiring flow-through. The operation may be not limited to clicking, long pressing, double clicking, sliding, or the like. The user can trigger the circulation line unit through the designated operation, and correspondingly, the client can display the standard circulation configuration item aiming at the circulation line unit in the configuration page after receiving the operation of configuring the circulation line unit by the user.

The standard flow-through configuration item may be used to configure a flow-through policy for subject screening criteria carried by the flow-through line unit. In particular, the flow-through policy may be used to configure subject screening criteria that require flow-through between configuration units. In some cases, the user may wish to circulate only a portion of the subject screening criteria between the configuration units. For example, configuration unit 1 may include 10 different subject screening criteria. The configuration unit 1 and the configuration unit 2 can be connected through a flow line unit. The user may configure the flow-through line unit such that the 5 subject screening criteria specified in configuration unit 1 are copied into configuration unit 2. In some cases, the user may need to add a new portion of the subject screening criteria. Correspondingly, the standard circulation configuration item can also provide the user with an option of adding a rule, and the user can add the subject screening standard needing circulation in the option. The client may circulate the newly added rules between different configuration units. In some embodiments, the user may also modify some parameters of the subject screening criteria that require synchronization in the flow-through line unit. Alternatively, the user may formulate a validation time, expiration time, etc. for the corresponding criteria for at least some of the subject screening criteria.

In some implementations, the standard flow configuration item may also include an option to modify the flow direction indicated by the flow line element. Specifically, the user may change the flow direction of the flow line cell through the standard flow configuration item.

The client can receive the operation of the user aiming at the standard circulation configuration item, so as to confirm the circulation strategy of the subject screening standard carried by the circulation line unit. Further, by configuring the completed circulation line unit, the subject screening standard corresponding to the circulation policy can be circulated in the connected unit.

In some embodiments, the method for generating a random grouping scheme may further include: receiving an operation of configuring the configuration unit by a user, wherein the configuration operation comprises a renaming operation and an operation of limiting the condition of the subjects in the group; and processing the configuration unit based on the configuration operation.

In some cases, the configuration unit may receive a configuration operation of a user to configure the configuration unit. By configuring the configuration unit under the condition that the configuration unit is triggered, convenience of configuration can be improved.

In some embodiments, the configuration operation may include a rename operation. Wherein the configuration unit is operable to add a name. The renaming operation may be used to modify the name of the configuration unit. Specifically, for example, names may be added and modified for any of a phase unit, a queue unit, an experiment group unit, or a control group unit.

In some embodiments, the configuring operation may further include an operation of defining a condition of the group of subjects, and the like. For any one of the stage unit, the queue unit, the experimental group unit or the control group unit, the corresponding condition of limiting the group-entering subjects can be configured so as to ensure that the clinical test is developed without being interfered by more non-drug factors to a certain extent. The conditions for defining the group of subjects may include, among others, limitations on age, limitations on gender, limitations on mental state, limitations on indication, and the like. In some embodiments, the step of receiving an operation of configuring the configuration unit by a user may include: under the condition that the configuration unit is triggered, a parameter configuration item is displayed in a designated area in the configuration page; wherein the first parameter configuration item is used for receiving a configuration item for configuring a configuration operation to configure the configuration unit; wherein the configuration items may include names of configuration units, group entry subject conditions defined by the configuration units, and the like.

In some embodiments, the operation of configuring the configuration unit by the user may be a design scheme of a stage, a queue, an experiment group, or a control group corresponding to the configuration unit. The design may include subject screening criteria that can be met by subjects entering the corresponding stage, cohort, experimental or control group. Subject screening criteria within the configuration unit may be formed based on user configuration of the configuration unit. Furthermore, the subject screening standard of the configuration unit can be circulated through the circulation line unit.

Referring to fig. 5, the embodiment of the present disclosure further provides a generation apparatus of a random grouping scheme. The generation device of the random grouping scheme can be applied to clinical trial projects. The generating means of the random grouping scheme may include: the first providing module and the first generating module.

The method comprises the steps of providing a module, providing a graphical configuration page, wherein the configuration page is provided with a configuration unit, the configuration unit comprises a stage unit, an experiment group unit and a control group unit, the stage unit is used for representing an experiment stage of a clinical experiment item, and the experiment group unit and the control group unit are respectively used for representing an experiment group and a control group in the experiment stage of the clinical experiment item.

The generation module is used for receiving the operation of a user on the configuration unit in the configuration page, generating and displaying a random grouping scheme of the clinical test items, and the random grouping scheme comprises a stage unit, and an experiment group unit and a control group unit which are associated with the stage unit.

The specific functions and effects achieved by the generating device of the random grouping scheme may be explained with reference to other embodiments of the present specification, and are not repeated herein. The respective modules in the generation means of the random grouping scheme of clinical trial items may be implemented in whole or in part by software, hardware, and combinations thereof. The modules can be embedded in hardware or independent of a processor in the computer equipment, and can also be stored in a memory in the computer equipment in a software mode, so that the processor can call and execute the operations corresponding to the modules.

Referring to fig. 6, the embodiment of the present disclosure further provides a computer device, including a memory and a processor, where the memory stores a computer program, and the processor executes the computer program to implement the method for generating the random grouping scheme in any one of the foregoing embodiments.

The present specification also provides a computer-readable storage medium having stored thereon a computer program which, when executed by a computer, causes the computer to perform the method of generating a random grouping scheme in any of the above embodiments.

The present description also provides a computer program product comprising instructions which, when executed by a computer, cause the computer to perform the method of generating a random grouping scheme in any of the above embodiments.

It will be appreciated that the specific examples herein are intended only to assist those skilled in the art in better understanding the embodiments of the present disclosure and are not intended to limit the scope of the present invention.

It should be understood that, in various embodiments of the present disclosure, the sequence number of each process does not mean that the execution sequence of each process should be determined by the function and the internal logic, and should not constitute any limitation on the implementation process of the embodiments of the present disclosure.

It will be appreciated that the various embodiments described in this specification may be implemented either alone or in combination, and are not limited in this regard.

Unless defined otherwise, all technical and scientific terms used in the embodiments of this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this specification belongs. The terminology used in the description is for the purpose of describing particular embodiments only and is not intended to limit the scope of the description. The term "and/or" as used in this specification includes any and all combinations of one or more of the associated listed items. As used in this specification and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

It will be appreciated that the processor of the embodiments of the present description may be an integrated circuit chip having signal processing capabilities. In implementation, the steps of the above method embodiments may be implemented by integrated logic circuits of hardware in a processor or instructions in software form. The processor may be a general purpose processor, a Digital signal processor (Digital SignalProcessor, DSP), an application specific integrated circuit (ApplicationSpecific Integrated Circuit, ASIC), an off-the-shelf programmable gate array (Field Programmable Gate Array, FPGA) or other programmable logic device, discrete gate or transistor logic device, discrete hardware components. The methods, steps and logic blocks disclosed in the embodiments of the present specification may be implemented or performed. A general purpose processor may be a microprocessor or the processor may be any conventional processor or the like. The steps of a method disclosed in connection with the embodiments of the present specification may be embodied directly in hardware, in a decoded processor, or in a combination of hardware and software modules in a decoded processor. The software modules may be located in a random access memory, flash memory, read only memory, programmable read only memory, or electrically erasable programmable memory, registers, etc. as well known in the art. The storage medium is located in a memory, and the processor reads the information in the memory and, in combination with its hardware, performs the steps of the above method.

It will be appreciated that the memory in the embodiments of this specification may be either volatile memory or nonvolatile memory, or may include both volatile and nonvolatile memory. The non-volatile memory may be a read-only memory (ROM), a programmable read-only memory (programmableROM, PROM), an erasable programmable read-only memory (erasablePROM, EPROM), an electrically erasable programmable read-only memory (EEPROM), or a flash memory, among others. The volatile memory may be Random Access Memory (RAM). It should be noted that the memory of the systems and methods described herein is intended to comprise, without being limited to, these and any other suitable types of memory.

Those of ordinary skill in the art will appreciate that the elements and algorithm steps described in connection with the embodiments disclosed herein can be implemented as electronic hardware, or combinations of computer software and electronic hardware. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the solution. Skilled artisans may implement the described functionality in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the present specification.

It will be clear to those skilled in the art that, for convenience and brevity of description, specific working procedures of the above-described system, apparatus and unit may refer to corresponding procedures in the foregoing method embodiments, and are not repeated herein.

In the several embodiments provided in this specification, it should be understood that the disclosed systems, apparatuses, and methods may be implemented in other ways. For example, the apparatus embodiments described above are merely illustrative, e.g., the division of the units is merely a logical function division, and there may be additional divisions when actually implemented, e.g., multiple units or components may be combined or integrated into another system, or some features may be omitted or not performed. Alternatively, the coupling or direct coupling or communication connection shown or discussed with each other may be an indirect coupling or communication connection via some interfaces, devices or units, which may be in electrical, mechanical or other form.

The units described as separate units may or may not be physically separate, and units shown as units may or may not be physical units, may be located in one place, or may be distributed on a plurality of network units. Some or all of the units may be selected according to actual needs to achieve the purpose of the embodiment.

In addition, each functional unit in each embodiment of the present specification may be integrated into one processing unit, each unit may exist alone physically, or two or more units may be integrated into one unit.

The functions, if implemented in the form of software functional units and sold or used as a stand-alone product, may be stored in a computer-readable storage medium. Based on this understanding, the technical solutions of the present specification may be essentially or portions contributing to the prior art or portions of the technical solutions may be embodied in the form of a software product stored in a storage medium, including several instructions to cause a computer device (which may be a personal computer, a server, or a network device, etc.) to perform all or part of the steps of the methods described in the embodiments of the present specification. And the aforementioned storage medium includes: a usb disk, a removable hard disk, a read-only memory (ROM), a random-access memory (RAM), a magnetic disk, or an optical disk, etc.

The foregoing is merely specific embodiments of the present disclosure, but the scope of the present disclosure is not limited thereto, and any person skilled in the art can easily think about changes or substitutions within the technical scope disclosed in the present disclosure, and should be covered by the scope of the present disclosure. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. A method for generating a random grouping scheme for use in clinical trial projects, the method comprising:

providing a graphical configuration page, wherein the configuration page is provided with a plurality of configuration units, the configuration units comprise a stage unit, an experiment group unit and a control group unit, the stage unit is used for representing an experiment stage of the clinical experiment item, and the experiment group unit and the control group unit are respectively used for representing an experiment group and a control group in the experiment stage of the clinical experiment item; wherein the configuration unit is used for configuring subject screening criteria; the subject screening criteria represent the defined condition of the subject entering the corresponding test phase, experimental group or control group;

receiving the operation of a user on the configuration unit in the configuration page, and generating and displaying a random grouping scheme of the clinical trial items, wherein the random grouping scheme comprises a stage unit, and an experiment group unit and a control group unit which are associated with the stage unit; wherein the operations include a wired operation for any two different configuration units to circulate subject screening criteria within the connected configuration units in accordance with a configured circulation policy; wherein the flow-through means comprises at least one of: at least a portion of the subject screening criteria are replicated between the configuration units in a specified direction, at least a portion of the subject screening criteria are synchronized from a configuration unit corresponding to a start point of a wiring operation to a configuration unit corresponding to an end point of the wiring operation, or at least a portion of the subject screening criteria are bi-directionally synchronized between the configuration units.

2. The method of claim 1, wherein the step of receiving user action on the configuration unit within the configuration page, generating and presenting a random grouping scheme of the clinical trial items, comprises:

receiving operation of newly-built stage units in the configuration page by a user;

receiving operation of a user for newly creating an experiment group unit and a control group unit in a newly created stage unit, wherein the experiment group unit and the control group unit are nested in the stage unit;

generating a random grouping scheme of the clinical trial items based on the newly created phase unit and the experimental group unit and the control group unit nested within the phase unit;

a random grouping scheme of the generated clinical trial items is presented on the configuration page.

3. The method according to claim 2, wherein the method further comprises:

receiving the operation of dragging the experimental group unit and/or the control group unit by a user;

and adjusting the positions of the experimental group and/or the control group in the stage unit based on the end point of the dragging action.

4. The method of claim 2, wherein the configuration unit further comprises a queue unit; after the step of the receiving user creating the operation of the phase unit in the configuration page, before the step of the receiving user creating the operation of the experiment group unit and the contrast group unit in the created phase unit, the method further includes:

Receiving operation of a user for newly creating a queue unit in a newly created stage unit, wherein the queue unit is nested in the stage unit;

the step of receiving the operation of the user for newly creating the experimental group unit and the control group unit in the newly created stage unit specifically comprises the following steps:

and receiving operation of a user for newly creating an experiment group unit and a control group unit in the newly created queue unit, wherein the experiment group unit and the control group unit are nested in the queue unit.

5. The method of claim 4, wherein when there are a plurality of queue elements within the phase element, the method further comprises:

receiving an operation of dragging the queue unit by a user;

and adjusting positions of the plurality of queue units in the stage unit based on the end point of the dragging action.

6. The method according to claim 4, wherein the method further comprises:

receiving operation of connecting the configuration units by a user, wherein the connection operation aims at any two units of a stage unit, a queue unit, an experiment group unit and a comparison group unit in the same configuration unit;

based on the wiring operation, subject screening criteria in the connected configuration units are circulated in the connected units.

7. The method according to any one of claims 1 to 6, wherein when the configuration unit is plural, the method further comprises:

receiving operation of connecting the configuration units by a user, wherein the connection operation aims at any two different configuration units;

8. The method of claim 7, wherein the flow-through is: copying at least part of the subject screening criteria between the configuration units according to a specified direction, or synchronizing at least part of the subject screening criteria from the configuration unit corresponding to the start point of the wired operation to the configuration unit corresponding to the end point of the wired operation, and circulating the subject screening criteria in the connected configuration units in the connected units based on the wired operation, wherein the step comprises the following steps:

and circulating the subject screening standard in the unit positioned at the starting point towards the unit positioned at the ending point based on the starting point and the ending point of the connecting line operation.

9. The method of claim 7, wherein after the step of receiving operation of the subscriber to connect the configuration unit, the method further comprises:

And forming a flow line unit between the connected units based on the connection operation.

10. The method of claim 9, wherein the step of communicating the subject screening criteria within the connected configuration unit within the connected unit based on the wiring operation comprises:

receiving an operation of configuring the circulation line unit by a user;

displaying a standard flow configuration item for the flow line unit;

receiving the operation of a user aiming at the standard circulation configuration item, and confirming the circulation strategy of the subject screening standard carried by the circulation line unit;

and circulating the subject screening standard corresponding to the circulation strategy in the connected unit.

11. The method according to any one of claims 1 to 6, further comprising:

receiving an operation of configuring the configuration unit by a user, wherein the configuration operation comprises a renaming operation and an operation of limiting the condition of the subjects in the group;

and processing the configuration unit based on the configuration operation.

12. A generation device of a random grouping scheme for use in clinical trial projects, the device comprising:

the system comprises a providing module, a processing module and a control module, wherein the providing module is used for providing a graphical configuration page, the configuration page is provided with a plurality of configuration units, the configuration units comprise a stage unit, an experiment group unit and a control group unit, the stage unit is used for representing an experiment stage of the clinical experiment item, and the experiment group unit and the control group unit are respectively used for representing an experiment group and a control group in the experiment stage of the clinical experiment item; wherein the configuration unit is used for configuring subject screening criteria; the subject screening criteria represent the defined condition of the subject entering the corresponding test phase, experimental group or control group;

The generation module is used for receiving the operation of a user on the configuration unit in the configuration page, generating and displaying a random grouping scheme of the clinical test items, and the random grouping scheme comprises a stage unit, and an experiment group unit and a control group unit which are associated with the stage unit; wherein the operations include a wired operation for any two different configuration units to circulate subject screening criteria within the connected configuration units in accordance with a configured circulation policy; wherein the flow-through means comprises at least one of: at least a portion of the subject screening criteria are replicated between the configuration units in a specified direction, at least a portion of the subject screening criteria are synchronized from a configuration unit corresponding to a start point of a wiring operation to a configuration unit corresponding to an end point of the wiring operation, or at least a portion of the subject screening criteria are bi-directionally synchronized between the configuration units.

13. A computer device, characterized in that it comprises a memory storing a computer program and a processor implementing the method according to any of claims 1 to 11 when executing the computer program.

14. A computer readable storage medium, characterized in that the readable storage medium has stored thereon computer program instructions, which when executed by a processor, implement the method of any of claims 1 to 11.