CN113539395A - Method and system for risk control of pharmaceutical clinical trial projects - Google Patents
Method and system for risk control of pharmaceutical clinical trial projects Download PDFInfo
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- 238000000034 method Methods 0.000 title claims abstract description 44
- 238000012954 risk control Methods 0.000 title claims abstract description 40
- 238000012360 testing method Methods 0.000 claims abstract description 42
- 239000003814 drug Substances 0.000 claims abstract description 40
- 230000004913 activation Effects 0.000 claims abstract description 32
- 229940079593 drug Drugs 0.000 claims abstract description 31
- 238000006243 chemical reaction Methods 0.000 claims abstract description 10
- 230000008569 process Effects 0.000 claims description 15
- 230000002411 adverse Effects 0.000 claims description 8
- 238000011156 evaluation Methods 0.000 claims description 8
- 239000008280 blood Substances 0.000 claims description 6
- 210000004369 blood Anatomy 0.000 claims description 6
- 238000004364 calculation method Methods 0.000 claims description 5
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- 230000009471 action Effects 0.000 description 6
- 238000004321 preservation Methods 0.000 description 4
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- 230000009286 beneficial effect Effects 0.000 description 2
- 238000003759 clinical diagnosis Methods 0.000 description 2
- 230000007717 exclusion Effects 0.000 description 2
- 238000011477 surgical intervention Methods 0.000 description 2
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Abstract
The invention provides a method and a system for risk control of a drug clinical test project, and relates to the technical field of project risk control. The method comprises the steps of obtaining subject data provided by a drug clinical test risk control system, and carrying out format conversion, classification and arrangement through a data conversion center; acquiring risk index data according to the classified and screened effective clinical test data; and judging whether the risk index data triggers a corresponding early warning event or not according to a preset activation condition, and if so, pushing the early warning event to a project principal. According to the method, risk item data are structured and managed in a flow manner, and PD or adverse event conditions triggering early warning are analyzed and sorted out through data, so that data basis is provided for risk control of a clinical trial project of a medicine to be executed in the future or a clinical research project initiated by a researcher; the completely reserved risk data also provides basis for clinical research of similar projects and varieties and protection of test subjects.
Description
Technical Field
The invention relates to the technical field of project risk control, in particular to a method and a system for risk control of a drug clinical test project.
Background
In the current practice of drug clinical trial project management, project risk control is essential because the failure of a trial project to complete or recruit subjects on a predetermined schedule, or the failure of a trial project to start on time or data lock, etc. are all possible risk factors.
Currently, institutions or participating hospitals use existing working regimes to restrict and standardize the operation of clinical staff, often through documentation or operator work experience to judge and manage risk information arising from pharmaceutical clinical trial projects or projects of clinical research projects initiated by researchers.
However, the above method is relatively dispersive in storage of critical risk data generated during clinical trials, an effective data system cannot be formed, and execution of leaving or losing important links is easy to occur.
Disclosure of Invention
Technical problem to be solved
Aiming at the defects of the prior art, the invention provides a method and a system for risk control of a drug clinical test project, which solve the technical problem that the storage of risk key data is relatively dispersed.
(II) technical scheme
In order to achieve the purpose, the invention is realized by the following technical scheme:
a method for risk control of a pharmaceutical clinical trial program, comprising:
s1, obtaining subject data provided by the drug clinical test risk control system, and performing format conversion, classification and arrangement through a data conversion center;
s2, acquiring risk index data according to the classified and screened effective clinical test data;
and S3, judging whether the risk index data trigger a corresponding early warning event or not according to a preset activation condition, and if so, pushing the early warning event to a project principal.
Preferably, the subject data includes basic information of the subject and clinical trial process data;
the basic information refers to physiological index data associated with the subject, including the code, sex, age, blood type and height of the subject;
the clinical trial process data refers to data associated with subject safety, including PD event type data, number of PD events generated, adverse event type data, and number of adverse events generated.
Preferably, the S1 further includes performing, by the data conversion center, a warehousing operation on the classified and screened valid clinical test data.
Preferably, the S2 specifically includes:
s21, obtaining risk key data of the subject according to the classified and screened effective clinical test data;
and S22, acquiring the risk index data through a calculation center by adopting an evaluation algorithm according to the risk key data.
Preferably, the activation condition in S3 includes a first activation condition corresponding to a PD event and a second activation condition corresponding to an adverse event.
A system for risk control of a pharmaceutical clinical trial project, comprising:
the acquisition module is used for acquiring the data of the testee provided by the drug clinical test risk control system, and performing format conversion, classification and arrangement through the data conversion center;
the calculation module is used for acquiring risk index data according to the classified and screened effective clinical test data;
and the judging module is used for judging whether the risk index data triggers the corresponding early warning event or not according to a preset activation condition, and if so, pushing the early warning event to a project principal.
Preferably, the subject data includes basic information of the subject and clinical trial process data;
the basic information refers to physiological index data associated with the subject, including the code, sex, age, blood type and height of the subject;
the clinical trial process data refers to data associated with subject safety, including PD event type data, number of PD events generated, adverse event type data, and number of adverse events generated.
Preferably, the acquisition module is further configured to perform warehousing operation on the classified and screened effective clinical test data through a data conversion center.
Preferably, the calculation module includes:
the risk key data acquisition module is used for acquiring risk key data of the testee according to the classified and screened effective clinical test data;
and the risk index data acquisition module is used for acquiring the risk index data through a calculation center by adopting an evaluation algorithm according to the risk key data.
Preferably, the activation condition includes a first activation condition corresponding to a PD event and a second activation condition corresponding to an adverse event.
(III) advantageous effects
The invention provides a method and a system for risk control of a clinical trial project of a medicament. Compared with the prior art, the method has the following beneficial effects:
the method comprises the steps of obtaining subject data provided by a drug clinical test risk control system, and carrying out format conversion, classification and arrangement through a data conversion center; acquiring risk index data according to the classified and screened effective clinical test data; and judging whether the risk index data triggers a corresponding early warning event or not according to a preset activation condition, if so, pushing the early warning event to a project principal, and the project principal performs further project processing actions according to the received early warning event and arranges and archives an effective processing scheme for outgoing. According to the method, risk item data are structured and managed in a flow manner, and PD or adverse event conditions triggering early warning are analyzed and sorted out through data, so that data basis is provided for risk control of a clinical trial project of a medicine to be executed in the future or a clinical research project initiated by a researcher; the completely reserved risk data also provides basis for clinical research of similar projects and varieties and protection of test subjects.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.
FIG. 1 is a schematic flow chart of a method for risk control of a clinical trial item of medication according to an embodiment of the present invention;
fig. 2 is a block diagram of a system for risk control of a clinical trial item of a drug according to an embodiment of the present invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention are clearly and completely described, and it is obvious that the described embodiments are a part of the embodiments of the present invention, but not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The embodiment of the application solves the technical problem of scattered risk key data storage by providing a method and a system for risk control of a drug clinical test project.
In order to solve the technical problems, the general idea of the embodiment of the application is as follows:
the method comprises the steps of obtaining subject data provided by a drug clinical test risk control system, and carrying out format conversion, classification and arrangement through a data conversion center; acquiring risk index data according to the classified and screened effective clinical test data; and judging whether the risk index data triggers a corresponding early warning event or not according to a preset activation condition, if so, pushing the early warning event to a project principal, and the project principal making a further project processing action according to the received early warning event. According to the embodiment of the invention, risk item data are structured and managed in a flow way, and PD or adverse event conditions triggering early warning are analyzed and sorted out through data, so that data basis is provided for risk control of a clinical trial item of a medicine or a clinical research item initiated by a researcher to be executed in the future; the completely reserved risk data also provides basis for clinical research of similar projects and varieties and protection of test subjects.
In order to better understand the technical solution, the technical solution will be described in detail with reference to the drawings and the specific embodiments.
Example 1:
as shown in fig. 1, an embodiment of the present invention provides a method for risk control of a clinical trial project of a drug, including:
and S1, acquiring the data of the testee provided by the drug clinical test risk control system, and performing format conversion, classification and arrangement through a data conversion center.
The subject data includes basic information and clinical trial process data of the subject;
the basic information refers to physiological index data associated with the subject, including the code, sex, age, blood type and height of the subject;
the clinical trial process data refers to data associated with subject safety, including PD event type data, number of PD events generated, adverse event type data, and number of adverse events generated.
The step also comprises the step of performing warehousing operation on the classified and screened effective clinical test data through a data conversion center, specifically, inputting the effective clinical test data into a data storage center for storage, and completely reserving risk data. The data storage center is used for uniformly storing clinical test data information and permanently storing effective data identification.
S2, obtaining risk index data according to the classified and screened effective clinical test data, and specifically comprising the following steps:
s21, obtaining risk key data of the subject according to the classified and screened effective clinical test data;
and S22, acquiring the risk index data through a calculation center by adopting an evaluation algorithm according to the risk key data.
And S3, judging whether the risk index data trigger a corresponding early warning event or not according to a preset activation condition, and if so, pushing the early warning event to a project principal.
The activation condition comprises a first activation condition corresponding to the PD event and a second activation condition corresponding to the adverse event; specifically, the method comprises the following steps of;
first, to clarify the PD event type includes
01 the medicine is not taken/taken more/taken by mistake/forbidden medicines are used;
02 does not meet the inclusion criteria/meets the exclusion criteria;
03 missing checking the effectiveness evaluation index;
04 using the apparatus;
05 drug preservation/device preservation;
06 disruption random;
07 missing checking safety index;
08 ultra-window: the subject is the same;
09 superwindow: the reason of the investigator;
10, super window: force is not resisted;
11 others.
The first activation condition includes:
1 or more times of any one of the PD event types 01-06;
or greater than 10% of subjects (by number) develop any of the above PD types 07-10.
The second activation condition includes:
SAE in the same clinical diagnosis in different subjects;
or the same subject has 3 or more SAEs arbitrarily diagnosed;
or the occurrence of unknown SAE that may be drug/device related;
or different subjects developing the same unknown SAE that may be drug/device related;
or the occurrence of unknown serious adverse events that may be associated with instrument surgery;
or different subjects developing the same unknown serious adverse event that may be associated with a surgical intervention;
or a SAE in which death occurs.
Example 2:
as shown in fig. 2, an embodiment of the present invention provides a system for risk control of a clinical trial project of drugs, including:
and the acquisition module is used for acquiring the data of the testee provided by the drug clinical test risk control system, and performing format conversion, classification and arrangement through the data conversion center.
The subject data includes basic information and clinical trial process data of the subject;
the basic information refers to physiological index data associated with the subject, including the code, sex, age, blood type and height of the subject;
the clinical trial process data refers to data associated with subject safety, including PD event type data, number of PD events generated, adverse event type data, and number of adverse events generated.
The acquisition module is also used for performing warehousing operation on the classified and screened effective clinical test data through a data conversion center, and specifically, the effective clinical test data are input into a data storage center for storage, so that risk data are completely reserved. The data storage center is used for uniformly storing clinical test data information and permanently storing effective data identification.
The calculation module is used for acquiring risk index data according to the classified and screened effective clinical test data, and specifically comprises the following steps:
the risk key data acquisition module is used for acquiring risk key data of the testee according to the classified and screened effective clinical test data;
and the risk index data acquisition module is used for acquiring the risk index data through a calculation center by adopting an evaluation algorithm according to the risk key data.
And the judging module is used for judging whether the risk index data triggers the corresponding early warning event or not according to a preset activation condition, and if so, pushing the early warning event to a project principal.
The activation condition comprises a first activation condition corresponding to the PD event and a second activation condition corresponding to the adverse event; specifically, the method comprises the following steps of;
first, to clarify the PD event type includes
01 the medicine is not taken/taken more/taken by mistake/forbidden medicines are used;
02 does not meet the inclusion criteria/meets the exclusion criteria;
03 missing checking the effectiveness evaluation index;
04 using the apparatus;
05 drug preservation/device preservation;
06 disruption random;
07 missing checking safety index;
08 ultra-window: the subject is the same;
09 superwindow: the reason of the investigator;
10, super window: force is not resisted;
11 others.
The first activation condition includes:
1 or more times of any one of the PD event types 01-06;
or greater than 10% of subjects (by number) develop any of the above PD types 07-10.
The second activation condition includes:
SAE in the same clinical diagnosis in different subjects;
or the same subject has 3 or more SAEs arbitrarily diagnosed;
or the occurrence of unknown SAE that may be drug/device related;
or different subjects developing the same unknown SAE that may be drug/device related;
or the occurrence of unknown serious adverse events that may be associated with instrument surgery;
or different subjects developing the same unknown serious adverse event that may be associated with a surgical intervention;
or a SAE in which death occurs.
In summary, compared with the prior art, the method has the following beneficial effects:
the method comprises the steps of obtaining subject data provided by a drug clinical test risk control system, and carrying out format conversion, classification and arrangement through a data conversion center; acquiring risk index data according to the classified and screened effective clinical test data; and judging whether the risk index data triggers a corresponding early warning event or not according to a preset activation condition, if so, pushing the early warning event to a project principal, and the project principal making a further project processing action according to the received early warning event. According to the embodiment of the invention, risk item data are structured and managed in a flow way, and PD or adverse event conditions triggering early warning are analyzed and sorted out through data, so that data basis is provided for risk control of a clinical trial item of a medicine or a clinical research item initiated by a researcher to be executed in the future; the completely reserved risk data also provides basis for clinical research of similar projects and varieties and protection of test subjects.
It is noted that, herein, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising an … …" does not exclude the presence of other identical elements in a process, method, article, or apparatus that comprises the element.
The above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present invention.
Claims (10)
1. A method for risk control of a pharmaceutical clinical trial program, comprising:
s1, obtaining subject data provided by the drug clinical test risk control system, and performing format conversion, classification and arrangement through a data conversion center;
s2, acquiring risk index data according to the classified and screened effective clinical test data;
and S3, judging whether the risk index data trigger a corresponding early warning event or not according to a preset activation condition, and if so, pushing the early warning event to a project principal.
2. A method for risk control of a pharmaceutical clinical trial project according to claim 1, wherein the subject data includes basic information of the subject and clinical trial process data;
the basic information refers to physiological index data associated with the subject, including the code, sex, age, blood type and height of the subject;
the clinical trial process data refers to data associated with subject safety, including PD event type data, number of PD events generated, adverse event type data, and number of adverse events generated.
3. The method for risk control of a clinical trial project of drugs according to claim 1, wherein the step S1 further comprises performing a binning operation on the classified and screened valid clinical trial data by the data transformation center.
4. The method for risk control of a clinical trial project of drugs according to claim 1, wherein the S2 specifically comprises:
s21, obtaining risk key data of the subject according to the classified and screened effective clinical test data;
and S22, acquiring the risk index data through a calculation center by adopting an evaluation algorithm according to the risk key data.
5. A method for risk control of a clinical trial project of drugs according to claim 1, wherein the activation condition in S3 comprises a first activation condition corresponding to a PD event and a second activation condition corresponding to an adverse event.
6. A system for risk control of a pharmaceutical clinical trial project, comprising:
the acquisition module is used for acquiring the data of the testee provided by the drug clinical test risk control system, and performing format conversion, classification and arrangement through the data conversion center;
the calculation module is used for acquiring risk index data according to the classified and screened effective clinical test data;
and the judging module is used for judging whether the risk index data triggers the corresponding early warning event or not according to a preset activation condition, and if so, pushing the early warning event to a project principal.
7. A system for risk control of a pharmaceutical clinical trial project according to claim 1, wherein the subject data includes basic information of the subject and clinical trial process data;
the basic information refers to physiological index data associated with the subject, including the code, sex, age, blood type and height of the subject;
the clinical trial process data refers to data associated with subject safety, including PD event type data, number of PD events generated, adverse event type data, and number of adverse events generated.
8. The system for risk control of clinical trial projects for pharmaceuticals according to claim 6, wherein the collection module is further configured to perform warehousing of the classified and screened valid clinical trial data by the data transformation center.
9. A system for risk control of a clinical trial project for pharmaceuticals according to claim 6, wherein the calculation module comprises:
the risk key data acquisition module is used for acquiring risk key data of the testee according to the classified and screened effective clinical test data;
and the risk index data acquisition module is used for acquiring the risk index data through a calculation center by adopting an evaluation algorithm according to the risk key data.
10. A system for risk control of a clinical trial project of drugs according to claim 6, wherein the activation condition comprises a first activation condition corresponding to a PD event and a second activation condition corresponding to an adverse event.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116128299A (en) * | 2023-01-09 | 2023-05-16 | 杭州泰格医药科技股份有限公司 | Clinical test quality risk monitoring method, device, computer equipment and storage medium |
| CN116612845A (en) * | 2023-07-21 | 2023-08-18 | 北京惠每云科技有限公司 | Clinical test risk reminding method and device, electronic equipment and storage medium |
| CN117973878A (en) * | 2024-03-29 | 2024-05-03 | 鼎泰(南京)临床医学研究有限公司 | Risk management method based on risk assessment tool FMEA |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20020187483A1 (en) * | 2001-04-20 | 2002-12-12 | Cerner Corporation | Computer system for providing information about the risk of an atypical clinical event based upon genetic information |
| CN108932968A (en) * | 2018-05-21 | 2018-12-04 | 上海市第六人民医院 | A kind of clinical trial subjects management system |
| CN111145848A (en) * | 2019-12-31 | 2020-05-12 | 天津开心生活科技有限公司 | Method, device, medium and equipment for detecting adverse reaction events in clinical test |
| CN111640475A (en) * | 2020-04-29 | 2020-09-08 | 上海米帝信息技术有限公司 | Management system for clinical test |
-
2021
- 2021-06-22 CN CN202110693655.1A patent/CN113539395A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20020187483A1 (en) * | 2001-04-20 | 2002-12-12 | Cerner Corporation | Computer system for providing information about the risk of an atypical clinical event based upon genetic information |
| CN108932968A (en) * | 2018-05-21 | 2018-12-04 | 上海市第六人民医院 | A kind of clinical trial subjects management system |
| CN111145848A (en) * | 2019-12-31 | 2020-05-12 | 天津开心生活科技有限公司 | Method, device, medium and equipment for detecting adverse reaction events in clinical test |
| CN111640475A (en) * | 2020-04-29 | 2020-09-08 | 上海米帝信息技术有限公司 | Management system for clinical test |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116128299A (en) * | 2023-01-09 | 2023-05-16 | 杭州泰格医药科技股份有限公司 | Clinical test quality risk monitoring method, device, computer equipment and storage medium |
| CN116128299B (en) * | 2023-01-09 | 2024-03-19 | 杭州泰格医药科技股份有限公司 | Clinical test quality risk monitoring method, device, computer equipment and storage medium |
| CN116612845A (en) * | 2023-07-21 | 2023-08-18 | 北京惠每云科技有限公司 | Clinical test risk reminding method and device, electronic equipment and storage medium |
| CN116612845B (en) * | 2023-07-21 | 2023-11-24 | 北京惠每云科技有限公司 | Clinical test risk reminding method and device, electronic equipment and storage medium |
| CN117973878A (en) * | 2024-03-29 | 2024-05-03 | 鼎泰(南京)临床医学研究有限公司 | Risk management method based on risk assessment tool FMEA |
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Application publication date: 20211022 |
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| RJ01 | Rejection of invention patent application after publication |