WO2020029633A1 - "百万例临床真实世界研究"的管理***及方法 - Google Patents

"百万例临床真实世界研究"的管理***及方法 Download PDF

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Publication number
WO2020029633A1
WO2020029633A1 PCT/CN2019/087345 CN2019087345W WO2020029633A1 WO 2020029633 A1 WO2020029633 A1 WO 2020029633A1 CN 2019087345 W CN2019087345 W CN 2019087345W WO 2020029633 A1 WO2020029633 A1 WO 2020029633A1
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recruitment
medical technology
subject
professional
research
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PCT/CN2019/087345
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English (en)
French (fr)
Inventor
白礼西
余曙光
李明权
卿玉玲
杨靖
李磊
秦少容
周洪
金思岑
杨巧巧
赵嘉将
朱昊
桑勤
蒋志
谢红燕
冉容
李和林
王钧冬
李俊龙
叶河江
张钊
孙媛媛
陈康
覃学
李燕
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太极集团有限公司
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Publication of WO2020029633A1 publication Critical patent/WO2020029633A1/zh

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    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06F—ELECTRIC DIGITAL DATA PROCESSING
    • G06F16/00—Information retrieval; Database structures therefor; File system structures therefor
    • G06F16/90—Details of database functions independent of the retrieved data types
    • G06F16/95—Retrieval from the web
    • G06F16/955—Retrieval from the web using information identifiers, e.g. uniform resource locators [URL]
    • G06F16/9554—Retrieval from the web using information identifiers, e.g. uniform resource locators [URL] by using bar codes
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H70/00—ICT specially adapted for the handling or processing of medical references
    • G16H70/40—ICT specially adapted for the handling or processing of medical references relating to drugs, e.g. their side effects or intended usage

Definitions

  • the invention relates to the technical field of pharmaceutical clinical trial management, and has a management system and method related to "a million clinical real-world studies”.
  • RCT-based research has solved the issue of the effectiveness and safety of new drugs.
  • RCT selects a specific sample of a certain sample through a series of inclusion exclusion criteria.
  • RCT includes more restrictions on the population and strict control of medication conditions, which makes the research results more internal and external.
  • it is poor and cannot be generalized in real clinical practice.
  • RCT rarely obtains information about concomitant diseases and concomitant treatments, and often adopts more interventions in order to comply with research protocols. This is also not very realistic in clinical practice.
  • RCT has the following problems: the narrow age range of test subjects, the limited number of clinical trials, the strict control of medication conditions, and the short duration of medication. It is difficult to draw conclusions about the overall safety and effectiveness of drugs. It is suitable for re-evaluating the safety and effectiveness of traditional Chinese medicines such as Huoxiangzhengqi oral liquid. Therefore, the concepts and methods of real-world research are put forward to reflect the real-world population through "real-world samples”.
  • Real-world study is a formal evidence-based concept that was formally introduced in 1992, and has now more than 20 years, which has profoundly affected medical clinical practice and medical research.
  • Real-world research originated from practical clinical trials and was first applied to the scope of pharmacoepidemiology. It refers to the large sample size (covering a larger representative population) and in the real medical process, Non-randomly select treatments based on the patient's actual condition and willingness, conduct long-term evaluations, focus on meaningful outcome treatments, and evaluate the external effectiveness and safety of interventions in a wide range of real medical procedures.
  • Comprehensive indicators which can more realistically collect relevant information on the safety and effectiveness of medicines, thereby providing an important basis for evaluating the benefits-risks of medicines and taking corresponding measures.
  • RWS is a new concept for conducting clinical re-evaluation research of traditional Chinese medicine after marketing. It will surely be fully applied and tested in the practice of re-evaluation of traditional Chinese medicine after marketing.
  • CN104318355A discloses a vaccine clinical trial network management method and system.
  • the method includes: scanning a smart tag on a vaccination certificate held by a subject, collecting a photograph of the subject, and storing the photograph in a clinical trial database; performing a physical examination on the subject according to a preset medical examination item and recording the medical examination data After that, the subjects are screened, and then the subjects are grouped and numbered, and the subject's vaccination information is obtained, and then the subject is automatically called for biological sample collection; the intelligence on the process card of the subject is scanned Label, obtain the corresponding vaccination information of the subject according to the corresponding data stored in the clinical trial database, after the subject is vaccinated, record the vaccination information and store it in the clinical trial database, and finally perform observation registration and measurement of the test subject Body temperature.
  • the difference between the system of the present invention and the reference file is mainly 1) the product is different, the present invention is directed to an OTC drug, a Chinese medicine product, and the comparative file is directed to a vaccine, a regulated biological product; 2) the present invention The amount of data collection reached one million, and the comparison file did not disclose the amount of data; 3) The present invention uses the real-world research method, and the comparison file does not disclose the research method, which should be a traditional randomized controlled trial; 4) the present invention There is a remote system controlled by a researcher (pharmaceutical company or a cooperative scientific research institution). As a macro management system, a research form and two-dimensional code can be distributed. There is no corresponding system for the comparison file.
  • the code distribution system of the present invention Distribute a two-dimensional code to the doctor.
  • the similar smart tags in the comparison file are distributed to the subjects.
  • the two-dimensional code of the present invention is converted from the number representing the specific identity of the doctor.
  • the similar smart tags in the comparison file represent It is a subject;
  • the present invention has a device for recruiting subjects, there is no contrast file;
  • the photographing device of the present invention is used to take pictures of tongue coating, and the number of tongue coating is built Library, collected reference document for printing photographs a subject to the subject to facilitate the subsequent processes involved in vaccination card.
  • the system of the present invention has many differences compared with the comparison file CN104318355A.
  • CN105303034A discloses a system and method for distributing medicines for clinical trials.
  • the invention belongs to the field of medical equipment.
  • the system includes a medicine dispensing box, a controller, and a management setting unit.
  • the management setting unit is mainly used for drug distribution management.
  • This system can automatically record the detailed records of the distribution and recovery of test drugs, effectively reducing the labor in research.
  • This comparison file has less relevance to the present invention and is obviously different from the technical problem to be solved by the present invention.
  • CN106725314A discloses a Chinese medicine quantitative color discrimination diagnosis technology and method based on two-dimensional code and topological code.
  • the technical features of the present invention similar to the present invention are 1) quantified collection of color information of the tongue diagnosis, and 2) a two-dimensional code of the color diagnosis information.
  • the present invention collects photos of tongue coating, mainly white greasy coating, and establishes a tongue coating database to provide data support for the medication of Huoxiangzhengqi liquid; and the comparison file identifies the tongue-related color information such as tongue quality and tongue coating, which is convenient for accurate Chinese medicine
  • the technical problem solved by the present invention is more targeted.
  • the two-dimensional code of the present invention is converted from a number representing the specific identity of a doctor, and the two-dimensional code in the comparison file is mainly formed by the quantitative information coding of the color diagnosis.
  • the present invention there are many differences between the present invention and the comparative document CN106725314A.
  • the present invention provides a management system of "millions of real-world studies", which is used for clinical research management of subjects with a large sample size.
  • “Million cases of clinical real-world research" management system including: remote management center, multiple medical technology recruitment stations, multiple subject terminals, and pre-assigned to each professional in each medical technology recruitment station Recruitment equipment for recruiting subjects; the remote management center, multiple medical technology recruitment stations, and multiple subject terminals are connected through the Internet of Things, where:
  • the remote management center is used to generate multiple research forms in advance according to the acquired clinical trial design requirements, and to generate a unique identification office in advance based on the personal information of each professional in each medical technology recruitment station that is acquired.
  • the two-dimensional code of the professional staff distributing the research form and the two-dimensional code to each medical technology recruitment station through the Internet of Things; and receiving the feedback from the medical technology recruitment station by the subjects and professionals through the Internet of Things Completed research form;
  • the medical technology recruitment station is used to receive and store a research form and a two-dimensional code distributed by the remote management center, and when a subject terminal corresponding to the subject scans the two-dimensional code on the recruitment device and When the medical technology recruitment station establishes a communication connection, the research form is distributed to the subject terminal, and the completed research form is received by the subject terminal, and the information entered by the professional is obtained to Fill in the research form and upload it to the remote management center through the Internet of Things;
  • the recruiting device is used to display to the subject a two-dimensional code uniquely identifying the professional pre-configured on the recruiting device;
  • the subject terminal is configured to scan the QR code displayed by the recruitment device to establish a communication connection with the medical technology recruitment station of a corresponding professional through the Internet of Things, and receive the medical technology recruitment station through the Internet of Things
  • the distributed research form ; and obtaining information entered by the subject to fill in the research form, and feeding back the completed research form to the corresponding medical technology recruitment station through the Internet of Things.
  • the study form fed back by the subject terminal includes tongue fur image data of the subject
  • the management system further includes a color difference analyzer connected to the medical technology recruitment station through the Internet of Things for detecting the color difference of the subject tongue coating image data in the research form sent by the medical technology recruitment station. Value, and then feedback the detected color difference value to the medical technology recruitment station to mark the color difference value in the research form; and / or,
  • the remote management center / the medical technology recruitment station preprocesses the tongue coating image data of the subject to obtain black-and-white tongue coating image data, and classifies and builds a tongue coating image database according to gray values.
  • the remote management center includes:
  • a two-dimensional code generating device configured to obtain personal information of each professional invited by a research sponsor, and generate a two-dimensional code that uniquely identifies the professional according to the personal information;
  • the server is connected to the two-dimensional code generating device and the research form generating device, and is configured to store the research form and the two-dimensional code, and according to a pre-built medical technology recruitment station mathematical model, and according to the medical The number of medical technology recruiting stations calculated by the technical recruitment mathematical model.
  • a corresponding number of the research forms and corresponding QR codes are distributed to each invited medical technology recruiting station through the Internet of Things, and the feedback from the medical technology recruiting station is received.
  • the medical technology recruitment station includes:
  • a recruitment server configured to establish a communication connection with the server through the Internet of Things to receive the research form and the two-dimensional code distributed by the server; and when the subject terminal scans the recruitment device by When establishing a two-dimensional code, establish a communication connection with the subject terminal to obtain the identification information of the subject terminal and push it to the medical technology terminal;
  • a plurality of medical technology terminals connected to the recruitment server for receiving identification information of the subject terminal pushed by the recruitment server, and sending the research form to the subject terminal through the recruitment server, and Receive the research form filled out by the subject and returned by the subject terminal through the recruitment server, and obtain clinical information of the subject entered by the corresponding professional to fill in the research form, and then
  • the recruitment server uploads a research form filled out by the professional and the subject to the remote management center.
  • the recruitment server is further configured to generate a characteristic code that uniquely identifies the subject according to the subject personal information when a research form filled with the subject's personal information is obtained, and mark it in the research Form.
  • the research form includes a subject personal information section, a clinical research information section and an informed consent section; and / or,
  • the personal information of the professional includes a doctor's license number and / or qualification number and / or identification number and / or mobile phone number; the professional is a doctor, pharmacist or nurse, and the personal information of the professional is Entered by the research sponsor into the remote management center, or entered by the professional after logging in to the remote management center; and / or,
  • the recruitment device is a personal belonging of the professional, the personal item includes glasses and / or a lab coat and / or and / or a doctor's desk and / or a work permit; and the recruitment device is allocated to at least 10 provinces / area.
  • the gray value classification of the tongue coating image data includes: A, B, and C types, where the gray value of type A is 121-150, the gray value of type B is 151-190, and the gray value of type C is The degree value is 191-250; the gray value of healthy people is 90-120.
  • the server is further configured to construct a database of subjects and / or a database of recruiters.
  • the present invention also provides a method for managing "millions of real-world studies", which includes steps:
  • the remote management center obtains the clinical trial design requirements and generates corresponding research forms
  • the remote management center obtains personal information of each professional in each medical technology recruitment station invited, and generates a QR code that uniquely identifies the professional;
  • the remote management center sends the generated research form and two-dimensional code to the corresponding medical technology recruitment station through the Internet of Things, so that when the subject terminal scans the recruitment equipment office corresponding to the professional in the medical technology recruitment station After the displayed two-dimensional code establishes a communication connection with the medical technology recruitment station, obtain the research form from the medical technology recruitment station;
  • the remote management center receives the research form filled out by the subjects and professionals through the Internet of Things through the medical technology recruitment station;
  • the recruitment equipment is distributed to each professional in advance, and each recruitment equipment is pre-configured with the two-dimensional code that uniquely identifies the professional.
  • the method further includes steps:
  • the remote management center constructs a mathematical model of medical technology recruitment stations, and calculates the number of medical technology recruitment stations in combination with the total number of research forms; of which,
  • the research form sent from the medical technology recruitment station includes tongue fur image data of the subject, and the tongue fur image data is marked with a corresponding color difference value / gray value;
  • the color difference value is obtained by detecting the tongue coating image data collected by the subject terminal by a color difference analyzer, and feeding it back to the medical technology recruitment station, and the medical technology recruitment station is in the research form. marked;
  • the gray value is preprocessed by the medical technology recruitment station on the subject tongue coating image data collected by the subject terminal, and the black and white tone tongue coating image data is obtained and labeled in the research form. of.
  • the research form sent from the medical technology recruitment station includes tongue subject image data of the subject, and the management method further includes steps:
  • the remote management center preprocesses the tongue coating image data of each subject to obtain black and white tone tongue coating image data, and classifies and constructs a tongue coating image database according to the gray value.
  • the research form sent from the medical technology recruitment station includes the tongue fur image data of the subject
  • the management method further includes steps:
  • the remote management center preprocesses the tongue coating image data of each subject to obtain black and white tone tongue coating image data, and classifies and constructs a tongue coating image database according to the gray value.
  • the research form includes a subject personal information section, a clinical research information section and an informed consent section; and / or,
  • the personal information of the professional includes a doctor's license number and / or qualification number and / or identification number and / or mobile phone number; the professional is a doctor, pharmacist or nurse; and the personal information of the professional is Entered by the research sponsor into the remote management center, or entered by the professional after logging in to the remote management center; and / or,
  • the recruitment device is a personal belonging of the professional, and the personal belonging includes glasses and / or a lab coat and / or and / or a doctor's desk and / or a work permit.
  • the gray value classification of the tongue coating image data includes: A, B, and C types, where the gray value of type A is 121-150, the gray value of type B is 151-190, and the gray value of type C is The degree value is 191-250; the gray value of healthy people is 90-120.
  • the present invention also provides another "millions of real-world studies” management method, which includes steps:
  • the medical technology recruitment station establishes a communication connection with the remote management center through the Internet of Things and assists professionals in registering personal information;
  • the medical technology recruitment station receives the research form and the QR code uniquely identifying the corresponding professional distributed by the remote management center through the Internet of Things; wherein the research form is generated by the remote management center according to the clinical trial design requirements, and The two-dimensional code is generated by the remote management center according to the personal information;
  • the medical technology recruitment station sends the research form to the subject terminal corresponding to the subject.
  • the subject terminal scans the QR code on the recruitment device corresponding to the professional, A communication connection established by the medical technology recruitment station; the recruitment setting is pre-assigned to each professional in each medical technology recruitment station, and a two-dimensional code uniquely identifying a corresponding professional is pre-configured;
  • the medical technology recruitment station receives the research form filled out by the subject through the Internet of Things feedback from the subject terminal, and obtains the clinical information entered by the corresponding professional to fill in the research form, and then the subject
  • the research form filled out by professionals and professionals is uploaded to the remote management center.
  • the research form sent by the subject terminal includes the subject tongue coating image data
  • the method further includes steps:
  • the medical technology recruitment station sends the subject tongue coating image data to a color difference analyzer for detection, and marks the detected color difference value on the corresponding subject tongue coating image data.
  • the present invention also provides another "millions of real-world studies” management method, which includes steps:
  • the subject terminal scans the QR code that uniquely identifies the corresponding professional on the recruitment device to establish a communication connection with the medical technology recruitment station corresponding to the professional; wherein the QR code is a
  • the acquired personal information of professionals is generated and pre-configured on the recruitment equipment distributed to the professionals;
  • the subject terminal receives the research form issued by the medical technology recruitment station through the Internet of Things; wherein the research form is issued by the remote management center to the medical technology recruitment station through the Internet of Things, and is designed according to clinical trials Demand generation
  • the subject terminal obtains the information entered by the subject to fill in the research form, and feeds it back to the medical technology recruitment station; wherein the information entered by the subject includes the subject's tongue coating image data.
  • the information entered by the subject includes image data of the subject's tongue coating.
  • the system collects huge amounts of data, and at the same time realizes the function of recruiting subjects efficiently and at low cost. 2)
  • the system can be customized for the dose of the drug. Among the many clinical signs, the corresponding part is selected as the typical sign. Classified. 3) While conducting clinical trial research, this system will open the information barrier between 1 million subjects and doctors and pharmaceutical companies; the QR code allocated by the system will become the data wealth of applicants, and further realize doctor education, A carrier for needs such as medical consultation. 4)
  • the present invention can also predict or mine more adaptability of medicaments such as Huoxiangzhengqi liquid by means of big data, and provide data support for its safety tracking after listing.
  • FIG. 1a is a functional module schematic diagram of an embodiment of a management system of “a million clinical real-world studies” according to the present invention
  • FIG. 1b is a functional module schematic diagram of another embodiment of a management system of “a million clinical real-world studies” according to the present invention.
  • FIG. 2 is a schematic diagram showing a real-time interaction between a subject terminal, a recruitment server, a medical technology terminal, and a server of a remote management center in the management system in FIG. 1;
  • FIG. 3 is a flowchart of an embodiment of a management method for "a million clinical real-world studies" according to the present invention
  • FIG. 4 is a schematic diagram of an embodiment of recruitment equipment
  • FIG. 5 is a schematic diagram of classification of gray scale values of tongue coating.
  • the research sponsor in this article refers to the company that initiated Huoxiangzhengqi Oral Liquid or other "millions of clinical real-world studies", or the company is the manager of the management system in this article.
  • Professionals in the text refer to technical personnel with professional medical skills, such as pharmacists, doctors, or nurses, and when they are invited by the above-mentioned research sponsors to recruit patients to participate in "Million Clinical Real World Studies" This professional is also called recruiter.
  • the subject in this article refers to the patient who collected relevant data, such as personal information and tongue coating image data, in Huoxiangzhengqi Oral Liquid or other “million clinical real-world studies”, and the patient is Resources were invited to participate in the study at the call of recruiters.
  • the research form in this article is a form designed by the research sponsor for Huoxiangzhengqi Oral Liquid or other corresponding "millions of clinical real-world studies", which includes participants (such as subjects and their corresponding professionals) Information section, clinical research information section and informed consent section, wherein the clinical information section includes the subject's tongue coating image information field, and the subject's region, gender, age, temperature, height, weight, pulse, disease, medication And other information.
  • the remote management center in this article refers to a set of facilities controlled by the research sponsor, which is used to generate multiple research forms (such as n copies, n ⁇ 1000000) according to the clinical trial design requirements, and according to each
  • the personal information of the professional generates a two-dimensional code that uniquely identifies the professional; and issues a research form and a two-dimensional code through the Internet of Things, and receives feedback and a research form filled out by the subject and the professional.
  • the medical technology recruitment station in this article refers to a medical place for recruiting subjects, such as a pharmacy, pharmacy, clinic, community health station, or hospital, etc., which is equipped with multiple medical technology terminals.
  • a medical place for recruiting subjects such as a pharmacy, pharmacy, clinic, community health station, or hospital, etc.
  • the recruitment equipment is allocated to each medical technology recruitment station by the above-mentioned remote management center, and the QR code configured on the recruitment device may be configured in advance by the remote management center according to the professional information in each medical technology recruitment station.
  • the medical technology recruitment station distributes it to the corresponding professionals according to the two-dimensional code; of course, the two-dimensional code on the recruitment device can also be obtained by the medical technology recruitment station from a remote management center. After the respective two-dimensional code is configured on each recruitment device and then distributed to the corresponding professionals; of course, it can also be medical technology recruitment. After the recruitment device is distributed to each professional, each professional from the medical technology terminal After the station obtains the corresponding two-dimensional code, it is directly configured on the recruitment device.
  • the subject terminal in this article refers to the device that can establish a communication connection with the medical technology terminal by scanning the QR code on the recruitment device to obtain the research form and feedback the research form.
  • Mobile terminal etc.
  • a remote management center corresponding to a research sponsor, a plurality of medical technology recruitment stations and a plurality of recruitment equipment corresponding to professionals (that is, recruiters), and a subject terminal corresponding to a subject are provided, that is, Generate the corresponding research form according to the clinical trial design needs through the remote management center, and generate a QR code that uniquely identifies the professional based on the stored professional personal information, and then send the research form and QR code to the corresponding one through the Internet of Things Medical technology recruitment station, and when the subject's subject terminal scans the recruitment equipment pre-assigned by the professional to establish a communication connection with the medical technology recruitment station, the medical technology recruitment station (under the control of the professional) passes The Internet of Things sends the research form to the corresponding subject terminal, and when the subject terminal feedbacks the research form filled out by the subject to the medical technology recruitment station through the Internet of Things, the medical technology recruitment station pushes the research form to Professionals fill out and upload the completed research form to the remote management center, that is, the management system of
  • FIG. 1a a schematic diagram of an embodiment of a management system for a "millions of clinical real-world studies" according to the present invention.
  • the management system in this embodiment includes: a remote management center 1, multiple medical technology recruitment stations 2, multiple subject terminals 3, and multiple recruitment devices 4 for recruiting subjects; Among them, the remote management center 1, the medical technology recruitment station 2 and the subject terminal 3 are all connected through the Internet of Things.
  • the remote management center 1 is configured to generate a research form in advance according to the acquired clinical design requirements of Huoxiangzhengqi oral liquid, and generate a unique identifier in advance according to the personal information of each invited professional.
  • the remote management center 1 includes:
  • a two-dimensional code generating device configured to obtain personal information of a professional invited by a research sponsor, and generate a two-dimensional code that uniquely identifies the professional according to the personal information;
  • a research form generating device is used to obtain the design requirements of the Huoxiangzhengqi oral liquid clinical trial and to generate a corresponding research form according to the design need; specifically, the research form generating device may be a PC or a single chip microcomputer or a computer for input. Design the requirements and generate a smart terminal for the form;
  • the server is connected to the above-mentioned two-dimensional code generating device and research form generating device, and is used for storing the research form and the two-dimensional code, and for establishing a communication connection with the medical technology recruitment station through the Internet of Things to distribute research to the medical technology recruitment station Form and two-dimensional code, and receive the research form filled out by the subject from the medical technology recruitment station.
  • the design requirement is entered by the research sponsor into the remote management center, and the personal information of professionals can be obtained in advance by the research sponsor and entered into the remote management.
  • the invited professionals can also log in to the remote management center through the medical technology recruitment station, and enter the registration information.
  • the professional includes a doctor, or a pharmacist, or a nurse
  • the personal information includes a license number and / or a qualification number and / or an ID number and / or a mobile phone number.
  • the remote management center passes the generated research form and the corresponding QR code through the object. It is delivered online to the professional medical technology recruitment station for storage.
  • the research form may also be a professional who sends a download request to the server of the remote management center through the medical technology recruitment station, and then the server of the remote management center sends the download request to the medical technology recruitment station according to the download request.
  • the research form includes the subject's personal information section, clinical research information section and informed consent section; the clinical information section is filled with various clinical data by the subject / professional, such as subject tongue coating image data, of course Different pharmaceutical clinical trials may test different parts, so the clinical data may also be image data of other parts.
  • the server is also used to construct a recruiter database according to the QR code of each professional.
  • a two-dimensional code database can be formed, that is, a database of recruited personnel (professionals), which facilitates the optimization and integration of more medical resources, and reserves medical resources for subsequent clinical trials of other drugs. Therefore, when conducting a clinical trial of a new drug, it is only necessary to send invitation letters to each recruiter in the recruiter database, that is, professionals, and the corresponding medical technology terminal, without having to restart the recruitment of new majors in each region / province. Staff, to avoid wasting doctor resources due to disconnection due to the completion of a product clinical trial.
  • the medical technology recruitment station is used to receive and store the research form and two-dimensional code issued by the remote management center, and when the subject terminal corresponding to the subject scans the two-dimensional code on the recruitment device
  • a research form is sent to the subject terminal, and then the subject completes the research form and receives the feedback from the subject terminal, and uploads it to the remote management center through the Internet of Things .
  • the medical technology recruitment station includes:
  • the recruitment server establishes a communication connection with the server of the remote management center through the Internet of Things to receive and store the research form and two-dimensional code issued by the server; and when the subject terminal corresponding to the subject scans the second When maintaining the code, establish a communication connection with the subject terminal, and obtain the identification information (such as a mobile phone number) of the subject terminal, and then send the identification information to the medical technology terminal, and send it under the control instruction of the medical technology terminal. Sending the stored research form to the subject terminal;
  • a plurality of medical technology terminals are connected to the recruitment server for receiving identification information of the subject terminal sent by the recruitment server, and sending a research form to the subject terminal through the recruitment server, and receiving the subject terminal through recruitment
  • the server returns the research form filled by the subject, and obtains the clinical information entered by the professional (such as the diagnosis and treatment information for the subject corresponding to the subject terminal) to fill in the research form, and then through the recruitment server Upload the research forms completed by professionals and subjects to the remote management center.
  • the medical technology terminal communicates with the server through the recruitment server.
  • the server of the remote management center establishes a communication connection, and when the registration is completed, or when using the account assigned by the research sponsor to log in to the remote management center for the first time, the remote management center will soon generate a pre-generated research form and according to the professional
  • the two-dimensional code generated by the personal information is sent to a recruitment server corresponding to the medical technology recruitment station of the professional for storage.
  • the recruitment device is a personal belonging of a professional, which includes glasses and / or a lab coat and / or a sitting table and / or a work permit, and the recruitment device is invited by the research sponsor to himself Medical technology recruitment station (specifically, you can directly send an invitation letter with detailed project introduction to each medical technology recruitment station connected to the server on the remote management center; of course, you can also invite them face to face), the specific number of recruitment equipment It is distributed according to the number of recruiters in the medical technology recruitment station, and the QR code on the recruitment device can be the recruitment device that was already configured on the recruitment device when the remote management center distributed the recruitment device, or it can be medical technology
  • the recruiting station configures itself on the assigned recruiting device when it receives the QR code, or it can be configured by the professional on the recruiting device after obtaining the QR code from the medical technology recruiting station.
  • the subject terminal When the subject scans the QR code on the recruitment device through the subject terminal, the subject terminal establishes a communication connection with the recruitment server of the professional corresponding to the QR code, and at the same time, the recruitment server Information of the subject terminal, such as a phone number, is also obtained, so that the subject information is pushed to the medical technology terminal, and the stored research form is sent to the subject terminal according to the branch feedback from the medical technology terminal.
  • the recruitment server Information of the subject terminal such as a phone number
  • the recruitment device is dispatched to at least 10 different provinces / territories, so that multiple patient samples can be collected.
  • the recruitment device is assigned to different provinces / regions according to different seasons in order to collect data on subjects in different provinces / regions to achieve the diversity of patient samples. At the same time, it can also form a unique drug system in different regions of different climate zones, which is of great significance.
  • the above recruitment server is further configured to generate a characteristic code that uniquely identifies the subject according to the subject's personal information when the research form in which the subject's personal information is filled is obtained, and mark it in the research form.
  • the recruitment server / medical technology terminal of the medical technology recruitment station receives the research form feedback from the subject terminal
  • the research form is preprocessed.
  • the recruitment server automatically calls Photoshop And other mapping software (or medical technology terminal under the control of professionals to draw graphics software such as Photoshop) to convert the subject's tongue coating image data into black and white tones, then obtain its gray value and mark it in the research form, and then send it to the remote
  • the management center classifies and builds a tongue coating image database according to the gray value; of course, it is also possible to directly send the tongue coating data of the subject in black and white to the remote management center, and the remote management center will obtain the gray value and Mark, then classify according to the gray value and build a tongue fur image database.
  • the gray value classification of the tongue coating image data specifically includes: A, B, and C, where the gray value of class A is 121-150, the gray value of class B is 151-190, and the gray value of class C is The degree value is 191-250; the gray value of healthy people is 90-120.
  • the subject terminal 4 is used to scan the QR code displayed by the recruitment device to establish a communication connection through a recruitment server in a medical technology recruitment station of a professional corresponding to the recruitment device through the Internet of Things (specifically, Referring to FIG. 2, after scanning the code, a communication connection request is sent to the recruitment server, and a response from the recruitment server is received to establish a communication connection; wherein the communication connection request carries the identification information of the subject terminal), and receives from the recruitment server
  • the research form (specifically, see FIG. 2) After receiving the subject terminal identification information by the medical technology terminal, send a request to the recruiting server to issue a order to the subject terminal, and then the recruiting server sends the test request to the subject. (The research terminal sends a research form); and obtain the information entered by the subject to fill in the received research form, and feed back the completed research form to the recruitment server in the medical technology recruitment station through the Internet of Things.
  • the information entered by the subject includes personal information of the subject, such as region, gender, age, height, weight and other information, and tongue coating image data.
  • the subject of the tongue coating image data directly selects the camera function option in the tongue coating image information field in the research form, and then calls the camera module on the subject's terminal to take a picture, or the subject directly turns on the subject. Take a photo with the camera module on the tester's terminal, and then click the upload / add function option in the tongue fur image information bar to directly select the captured tongue fur image data.
  • the subject can also use another photographing device to take a picture and wirelessly. / Wired way is loaded to the tongue coating image information column, and the photographing device may be distributed to professionals by a remote management center, and then distributed to each subject by the professionals.
  • doctors and / or pharmacists and / or nurses search the public number on the mobile phone (that is, the medical technology terminal) WeChat platform and enter the "Tai Chi Huoxiang Zhengqi official service number" (that is, log in to the server of the remote management center); of course, you can also Entered by scanning the QR code of the official service number of Tai Chi Huo Xiang Zheng Qi;
  • Doctors and / or pharmacists and / or nurses register their personal information at the "Tai Chi Huoxiang Zhengqi Official Service Number" (that is, the server of the remote management center); this personal information includes equipment at the medical technology recruitment station Identification number, such as phone number; when registering personal information, it is required to upload a photo of a doctor's practice certificate, including the name page and practice address page, which cannot be replaced by a doctor's qualification certificate;
  • the QR code generation device of the remote management center generates a QR code that uniquely identifies the professional based on personal information, and the server distributes the QR code and the pre-generated research form to the medical technology recruitment station where the professional is located.
  • Recruitment server at the same time, after receiving the QR code, the medical technology recruitment station will configure the QR code of each professional to the pre-assigned work card (recruitment equipment), and then distribute it to the corresponding professional to carry with them carry;
  • the patient i.e. the subject
  • the mobile terminal i.e. the subject terminal
  • the mobile phone of the doctor and / or pharmacist and / or nurse obtains the identification information (such as a phone number) of the patient's mobile terminal through the recruitment server;
  • the doctor and / or pharmacist and / or nurse sends a request to the recruitment server to the recruitment server through the mobile phone, so that the recruitment server pushes a research form to the patient's mobile terminal.
  • the research form includes an electronic informed consent form, and the participants (professionals and professionals) Subjects) basic information forms, as well as clinical research information related forms such as the doctor's initial diagnosis questionnaire, patient log questionnaire, adverse event tracking questionnaire, and serious adverse event tracking questionnaire;
  • the patient consults the electronic informed consent on the mobile terminal (ie the subject terminal) and determines the informed consent;
  • the patient fills in the log questionnaire on the mobile terminal (ie, the subject terminal), and feeds it back to the medical technology terminal through the recruitment server;
  • Doctors and / or pharmacists and / or nurses consult patient logs and track patient status on the recruitment server through medical technology terminals;
  • the recruitment server generates AE and SAE record reports based on the research form.
  • AE and SAE record reports mainly include the following:
  • the AE record report when the patient fills in the special discomfort in the log questionnaire of the research form, the recruitment server generates an AE record according to the special discomfort in the research form, and creates an AE library and pushes it to the list. Medical technology terminal, so that doctors follow up with AE.
  • the SAE record reports that when the doctor determines in the medical technology terminal that the generated AE record belongs to one of the following situations, the recruitment server marks the AE record as SAE.
  • FIG. 1b a schematic diagram of an embodiment of a management system for another “million cases of clinical real-world research” according to the present invention.
  • the management system of this embodiment includes each of the first embodiment described above. Module, the difference is that the management system of this embodiment further includes:
  • a color difference analyzer which is connected to the recruitment server of the medical technology recruitment station through the Internet of Things, and is used to detect the subject tongue coating image data in the research form sent by the recruitment server in the medical technology recruitment station, and to detect the detected color difference The value is fed back to the recruitment server of the medical technology recruitment station, and then the recruitment server marks the color difference value in the research form.
  • a corresponding tongue fur image database can be constructed.
  • the subject ’s tongue coating image data may also be sent to the color difference analyzer for detection by the subject terminal directly through the Internet of Things; and in another specific embodiment, the color difference meter may also The detection result is sent to the server of the remote management center, and then the server of the remote management center is used to mark and build a corresponding tongue coating image database.
  • the number of the color difference analyzers may be determined according to an actual situation, and one may be provided at each medical technology recruitment station, or only one may be provided.
  • the present invention also provides a method for managing "millions of clinical real-world studies”.
  • “Clinical real-world research” is taken as an example for illustration, and detailed description is given in combination with specific examples.
  • the management method of “one million clinical real-world studies” in this embodiment specifically includes steps:
  • Step 1 The remote management center obtains the clinical trial design requirements and generates the corresponding research form.
  • the design requirement is entered by the research sponsor into the remote management center.
  • the design requirement includes the number of subjects required in the clinical trial, participant information, clinical research content, etc.
  • the research form includes clinical information research sections such as doctor's personal information section, subject's personal information section, informed consent section, doctor's initial diagnosis questionnaire, patient log questionnaire, adverse event tracking questionnaire, and serious adverse event tracking questionnaire for uploading by subjects.
  • Clinical data such as tongue coating image data.
  • Step 2 The remote management center obtains personal information of each professional in each invited medical technology recruitment station, and generates a QR code that uniquely identifies the professional.
  • the research sponsor can obtain the personal information of each invited professional in advance (for example, the recruitment information submitted by the professional / medical recruiting station) and enter it in the remote management center. It was entered by the invited professionals who logged in to the remote management center through the medical technology terminal of the medical technology recruitment station and registered online.
  • the professional includes a doctor, or a pharmacist, or a nurse, and the personal information includes a license number and / or a qualification number and / or an ID number and / or a mobile phone number.
  • Step 3 The remote management center sends the generated research form and two-dimensional code to each medical technology recruitment station through the Internet of Things, so that the subject terminal scans each professional corresponding to the medical technology recruitment station.
  • the two-dimensional code displayed on the recruitment device establishes a communication connection with the recruitment server in the medical technology recruitment station, thereby obtaining a research form from the recruitment server.
  • the remote management center passes the generated research form and the corresponding QR code through the object. It is delivered online to the professional medical technology recruitment station for storage.
  • the research form may also be a professional who sends a download request to the server of the remote management center through the medical technology recruitment station, and then the server of the remote management center sends the download request to the medical technology recruitment station according to the download request.
  • the research form includes a professional personal information section, a subject personal information section, a clinical research information section, and an informed consent section; the clinical information section includes a subject tongue coating image information field.
  • Step four the remote management center receives the research form filled out by the subject and the professional through the Internet of Things feedback from the medical technology recruitment station.
  • the subject terminal when a subject scans a QR code that uniquely identifies the professional on a recruitment device pre-assigned to a professional through a subject terminal, the subject terminal establishes a connection with the two-dimensional code.
  • the communication connection of the recruitment server in the medical technology recruitment station of the professional corresponding to the code.
  • the recruitment server in the medical technology recruitment station will also obtain the identification information of the subject terminal, such as the phone number, so that the subject
  • the terminal can upload the research form filled by the subject to the recruitment server of the medical technology recruitment station through the Internet of Things, and then forward it to the medical technology terminal by the recruitment server, and continue to be filled out by professionals.
  • the recruitment server After the completion of the filling, the recruitment server will It is forwarded to the remote management center.
  • the recruitment device is a personal belonging of a professional, including glasses and / or a lab coat (see FIG. 4) and / or and / or a doctor's desk and / or a work permit, and the recruitment device is researched by
  • the sponsor sends the invitation to the medical technology recruitment station (specifically, by sending an invitation letter with a detailed project introduction to each medical technology recruitment station connected to the server on the remote management center; of course, it can also invite them face to face)
  • the specific number of recruitment equipment is distributed according to the number of recruiters in the medical technology recruitment station, and the QR code on the recruitment equipment can be configured on the recruitment equipment when the remote management center distributed the recruitment equipment.
  • the medical technology recruitment station on the assigned recruitment device when it receives the QR code, or it can be configured by the professional on the recruitment device after obtaining the QR code from the medical technology recruitment station.
  • the subject terminal When the subject scans the QR code on the recruitment device through the subject terminal, the subject terminal establishes a communication connection with the recruitment server of the professional corresponding to the QR code, and at the same time, the recruitment server Information of the subject terminal, such as a phone number, is also obtained, so that the subject information is pushed to the medical technology terminal, and the stored research form is sent to the subject terminal according to the branch feedback from the medical technology terminal.
  • the method when the remote management center receives the research form filled with the subject's tongue coating image data, the method further includes the following steps:
  • the remote management center preprocesses the tongue coating image data, obtains the tongue coating image data in black and white tones, classifies them according to the gray value, and builds a tongue coating image database.
  • the gray value classification of tongue fur image data includes: A, B, and C, where the gray value of type A is 121-150, and type B The gray value is 151-190, the gray value of class C is 191-250; the gray value of healthy people is 90-120, see Figure 5.
  • the present invention also provides another "millions of clinical real-world studies" management method, which includes each of the above-mentioned third embodiments.
  • the difference is that, in this embodiment, the remote management center does not need to preprocess the received tongue coating image data to obtain the gray value, because the tongue coating image data received by the server of the remote management center has been The corresponding gray value / color difference value is marked.
  • the color difference value is obtained by the recruitment server / subject terminal of the medical technology recruitment station sending the tongue fur image data to the color difference analyzer for detection, and the color difference meter feeds back to the doctor through the Internet of Things.
  • the recruitment server / medical technology terminal of the technology recruitment station, and then the recruitment server / medical technology terminal of the medical technology recruitment station is marked in the research form; and the gray value is the recruitment server / medical technology of the medical technology recruitment station.
  • the terminal preprocesses the tongue fur image data of the subject collected by the subject terminal, obtains the tongue fur image data in black and white tones, and marks them in the research form.
  • the present invention also provides another "millions of clinical real-world studies” management method. The details are described below in conjunction with specific embodiments. Instructions.
  • the management method of "a million clinical real-world studies" in this embodiment specifically includes steps:
  • Step 1 The medical technology recruitment station establishes a communication connection with the remote management center through the Internet of Things and assists professionals in registering personal information.
  • the medical technology recruitment station includes a connected recruitment server and a plurality of medical technology terminals, wherein the recruitment server establishes a communication connection with the server of the remote management center through the Internet of Things, and is configured to receive and store the distribution issued by the server.
  • the medical technology terminal is connected to the recruitment server for Receiving the subject terminal identification information sent by the recruitment server, and sending a research form to the subject terminal through the recruitment server, and receiving the research form filled out by the subject and returned by the subject terminal through the recruitment server, And obtain the clinical information entered by the professional (such as the diagnosis and treatment information of the subject corresponding to the subject terminal) to complete the study form , Then the server will recruit professionals and research form the subjects fill uploaded to a remote management center.
  • the identification information of the subject terminal such as Mobile phone number
  • the medical technology terminal is connected to the recruitment server for Receiving the subject terminal identification information sent by the recruitment server, and sending a research form to the subject terminal through the recruitment server, and receiving the research form filled out by the subject and returned by the subject terminal through the recruitment server, And obtain the clinical information entered by the professional (such as the diagnosis and treatment information of the subject corresponding to the subject terminal) to complete the study form , Then the server will recruit professionals and research form the subjects fill uploaded to a remote management center.
  • the medical technology terminal when a professional enters the remote management center URL by scanning the corresponding QR code on the medical technology terminal in the medical technology recruitment station, the medical technology terminal
  • the recruitment server establishes a communication connection with the server of the remote management center, so that professionals can directly register with the remote management center through the medical technology terminal and register personal information.
  • the personal information of professionals includes a license number and / or qualification number and / or identification number and / or mobile phone number; the professional is a doctor, pharmacist or nurse.
  • Step 2 The medical technology recruitment station receives the research form and the QR code uniquely identifying the corresponding professional distributed by the remote management center through the Internet of Things.
  • the research form is generated by the remote management center according to the clinical trial design requirements (same as in the first or second embodiment above), and the two-dimensional code is the personal information registered by the remote management center in step 1. Generated.
  • the remote management center sends a pre-generated research form and a QR code generated according to the personal information registered by the professional to the professional corresponding through the Internet of Things.
  • the recruitment server in the medical technology recruitment station is stored.
  • the research form may also be that a professional sends a download request to a server of the remote management center through a medical technology terminal of a medical technology recruitment station, and the server of the remote management center sends the download request according to the download request.
  • Recruitment server for Medical Technology Recruitment Station includes the subject's personal information section, clinical research information section, and informed consent section; the clinical information section includes the subject's tongue coating image information field.
  • Step 3 The medical technology recruitment station sends the research form to the subject terminal corresponding to the subject.
  • the subject terminal scans a QR code that uniquely identifies the professional on the recruitment device corresponding to the professional
  • the communication connection established with the recruitment server in the medical technology recruitment station through the Internet of Things is selected by the research sponsor / professional, and is specifically a device that can be carried as a professional, including glasses and / or lab coats and / or and / or sitting tables and / or work permits, and distributed in advance
  • the QR code on the recruitment device is configured by the remote management center for the corresponding QR code of each professional on the recruitment device, or is received by the medical technology recruitment station
  • the staff of the medical technology recruitment station such as professionals, print the QR code and configure it on the recruitment device.
  • Step four The medical technology recruitment station receives the research form filled by the subject through the Internet of Things feedback from the subject terminal, and obtains the clinical information (such as initial diagnosis information) entered by the corresponding professional to fill in the research form and upload To the remote management center.
  • the clinical information such as initial diagnosis information
  • the subject after the subject receives the research form through the subject terminal, the subject starts to fill in the research form as required, and then feeds it back to the recruitment server of the medical technology recruitment station, such as filling in the subject's personal information , such as region, gender, age, body temperature, height, weight, etc., and tongue coating image data, where the subject of the tongue coating image data directly selects the photo function option in the tongue coating image information field in the research form, and then calls the Obtained by the camera module on the subject terminal, or the subject directly opens the camera module on the subject terminal to take a picture, and then clicks the upload / add function option in the tongue fur image information bar and directly selects the captured picture.
  • Tongue coating image data of course, the subject can also be loaded into the tongue coating image information bar wirelessly / wired after taking pictures with another camera device, and the camera device can be distributed to professionals by the remote management center, and then Distributed to each subject by a professional.
  • the method after receiving the research form feedback from the subject terminal, the method further includes the following steps:
  • the medical technology recruitment station also preprocesses the tongue coating image data of each subject to obtain black and white tone tongue coating image data, and then obtains the grayscale value of the black and white tone tongue coating image and feeds it back to the remote management center.
  • the tongue coating image data is automatically adjusted by the recruitment server to draw software such as Photoshop to adjust the tongue coating image data, or is operated by a professional in a medical technology terminal, such as calling Photoshop It is obtained after preprocessing; and the gray value classification of the tongue coating image data includes: A, B, and C, where the gray value of class A is 121-150, and the gray value of class B is 151-190, The gray value of class C is 191-250; the gray value of healthy people is 90-120.
  • the present invention also provides another method for managing "millions of clinical real-world studies", which includes each of the above-mentioned fifth embodiments.
  • the steps are different.
  • the tongue coating image data received by the medical technology recruitment station does not need to be preprocessed.
  • the subject tongue coating image data is sent to a pre-configured color difference analyzer through the Internet of Things.
  • the color difference value detected by the color difference meter is marked on the corresponding subject tongue fur image data.
  • the recruitment server of the color medical technology recruitment station sends tongue fur image data to the pre-configured color difference analyzer for detection through the Internet of Things, and then receives the detection result fed back by the color difference analyzer, and detects the detection result.
  • the results are marked in the study form.
  • the present invention also provides another "millions of clinical real-world studies” management method. The details are described below in conjunction with specific embodiments. Instructions.
  • the management method of "a million clinical real-world studies" in this embodiment specifically includes steps:
  • Step 1 The subject terminal scans the QR code that uniquely identifies the corresponding professional on the recruitment device to establish a communication connection with the medical technology recruitment station corresponding to the professional.
  • the two-dimensional code is generated by the remote management center according to the obtained personal information of the professional and is pre-configured on the recruitment device, or received by the medical technology recruitment station and issued by the remote management center.
  • the QR code is configured on the recruitment equipment pre-assigned by the research sponsor; and the recruitment equipment uses equipment that can be carried by professionals, including glasses and / or lab coats and / or and / or sitting tables and / Or work permit; among them, the personal information of professionals is obtained in advance by the research sponsor and entered in the remote management center, or the invited professionals can be recruited through medical technology.
  • Step 2 The subject terminal receives the research form issued by the medical technology recruitment station through the Internet of Things.
  • the research form is issued by the remote management center to the recruitment server in the medical technology recruitment station through the Internet of Things, and is generated according to the clinical trial design requirements, and the research form is a professional in the remote management center After successful registration, or after logging in to the remote management center for the first time through the account assigned by the research sponsor, the remote management center sends to the recruitment server of the professional medical technology recruitment station through the Internet of Things; of course, the research form can also After the professional sends a download request to the server of the remote management center through the medical technology recruitment station, the server of the remote management center sends the download request to the medical technology recruitment station according to the download request.
  • the research form includes a subject personal information section, a clinical research information section, and an informed consent section; the clinical information section includes a subject tongue coating image information field.
  • Step 3 The subject terminal obtains the information entered by the subject to fill in the research form, and feeds it back to the medical technology recruitment station.
  • the information entered by the subject on the subject terminal includes image data of the subject's tongue coating.

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Abstract

一种"百万例临床真实世界研究"的管理***，其包括远程管理中心（1）、多个医技招募站（2）、多个受试者终端（3）和多个用于招募受试者的招募设备（4）；该***能够实现海量数据的收集，且能够高效、低成本的招募受试者；进一步选取了舌苔作为典型体征，并进行分类存储；打通了100万受试者和医生、药企之间的信息屏障；该***分配的二维码将成为研究发起人的数据财富，并进一步实现医生教育、求医问诊等需求的载体；该***还用大数据的方式预测或挖掘藿香正气液等药剂/制剂更多的适应性，并为其上市后的安全性追踪提供数据支撑。

Description

“百万例临床真实世界研究”的管理***及方法 技术领域
本发明涉及药品临床试验管理技术领域，具有涉及一种“百万例临床真实世界研究”的管理***和方法。
背景技术
在循证医学时代，以RCT为主的研究方式解决了新药的有效性与安全性问题。但是也带来了很多困扰和难题，如RCT通过一系列入选排除标准选取一定样本的特定人群，RCT纳入人群限制较多，用药条件控制严格，使得研究结果的内部真实性较高，外部真实性却较差，无法确定在真实临床实践中的可推广性；另外出于控制变量的设计，RCT很少获得关于伴随疾病和伴随治疗的信息，并且为了依从研究方案，往往采取较多的干预措施，这在临床实践中也不太现实。总的来说RCT存在以下问题：试验对象年龄范围较窄、临床试验病例数有限、用药条件控制较严格、用药时间较短等，很难得出药品全面的安全性和有效性结论，因此，不适用于解决如藿香正气口服液等中药的上市后安全性和有效性再评价问题。故而，提出了真实世界研究的概念和方法，通过“真实世界样本”来反映真实世界总体。
真实世界研究(Real-world Study，RWS)是从1992年正式提出循证的概念，至现在超过20年，深刻影响医学临床实践与医学研究。真实世界研究起源于实用性临床试验，最早应用于药物流行病学范围，其是指在较大的样本量(覆盖具有代表性的更广大受试人群)的基础上，在真实医疗过程中，根据患者的实际病情和意愿非随机选择治疗措施，开展长期评价，并注重有意义的结局治疗，在广泛真实医疗过程中评价干预措施的外部有效性和安全性，并且由于试验时间较长，观察指标全面，可以较真实地收集药品安全性和有效性相关信息，从而为评价药品的受益-风险及采取相应 措施提供重要依据。故而，在保证人民群众用药安全、有效的前提下，基于RWS的中药上市后临床再评价研究可能延长药品的市场生命，也有利于药品生产企业的健康发展。RWS是开展上市后中药临床再评价研究的一种新理念，必将在中药上市后再评价实践工作中得到充分的应用和检验。
然而，由于RWS是一项庞大而***的工作，其复杂性、艰巨性、长期性使得RWS的管理面临着巨大的挑战。如为了开发和验证藿香正气液的多种临床适应症，2017年太极集团启动的“藿香正气液百万例真实世界研究项目”，该项目由中国中药协会、中华中医药学会、中华医学会、首都医科大学附属北京中医医院、西京医院、四川大学华西医院、成都中医药大学、太极集团等单位参与组织和实施。其创新之处在于发挥全国各地医生的力量，对祖辈传承下来的千古名方进行真实世界研究，用事例、数据证明藿香正气液对多种疾病有效、对哪些人群有效以及疗效有多可靠。该项目实施周期为5年，针对藿香正气液的临床运用，将通过真实世界研究方式，注册登记研究100万例真实案例。然而，这是一项庞大而***的工作，其复杂性、艰巨性、长期性都将考验项目组和企业的领导能力和创新精神。即在现有技术的基础上，要完成这个收集超大样本的真实世界研究还将面临着1)企业投资巨大；2)数据收集难度高；3)工作量庞大；4)数据异质性强；5)对统计方法要求更高等挑战。因此，如何高效、低成本的实现招募受试者，收集大量数据，是目前需要解决的问题。
在本发明请求优先权的基础上，国家知识产权局出具了一份检索报告，其列举出3篇对比文件，公开号分别是CN104318355A、CN105303034A、CN106725314A。CN104318355A公开了一种疫苗临床试验网络管理方法及***。该方法包括：对受试者持有的接种证上的智能标签进行扫描，采集受试者的照片，对应存储到临床试验数据库中；根据预设体检项目对受试者进行体检并记录体检数据后，对受试者进行筛选，进而对受试者进行分组及编号后，并获取该受试者的接种信息后自动呼叫受试者进行生物样本采集；扫描受试者的流程卡上的智能标签，根据临床试验数据库存储的相应 数据获得该受试者对应的疫苗接种信息，对受试者进行疫苗接种后，记录接种信息并存储到临床试验数据库中，最后进行留观登记以及测量受试者的体温。本发明的***与对比文件的区别主要在于1)产品不同，本发明针对的是一种OTC药品，一种中药制品，而对比文件针对的是疫苗，一种管制类生物制品；2)本发明的数据采集量达到了一百万例，而对比文件没有公开数据量；3)本发明采用了真实世界研究方法，对比文件没有公开研究方法，应该是采用传统的随机对照试验；4)本发明有一个由研究人(药厂或合作的科研机构)掌控的远程***，该***作为宏观管理，可派发研究表单和二维码，对比文件没有相对应的***；5)本发明的派码***派发二维码给医生，对比文件中类似的智能标签是派发给受试者；6)本发明的二维码由代表医生特异性身份的号码转化而来，对比文件中类似的智能标签代表的是受试者；7)本发明具备招募受试者的设备，对比文件没有；8)本发明的拍照设备用于拍摄舌苔的照片，建成舌苔数据库，对比文件中采集受试者照片用于打印成受试者流程卡便于后续参与疫苗接种。综上所述，本发明的***与对比文件CN104318355A相比有较多的不同之处。
CN105303034A公开了一种临床试验用药物分发记录的***及方法，该发明属于医疗器械领域，该***包括分药盒、控制器和管理设置单元，管理设置单元主要是用于药物分发管理。这套***能够实现自动记录试验用药分发及回收的详细记录，有效减轻研究中的劳动量。该对比文件与本发明的相关性较小，与本发明要解决的技术问题显然不同。
CN106725314A公开了一种基于二维码、拓扑码的中医量化辨色诊断技术和方法。该发明与本发明类似的技术特征有1)望舌诊色彩信息量化采集；2)望色诊信息的二维码。本发明采集舌苔照片，主要是白腻苔，建立一个舌苔数据库，为藿香正气液的用药提供数据支持；而对比文件对舌质、舌苔等与舌相关的颜色信息进行识别，便于中医精准用药，本发明解决的技术问题更具针对性。本发明的二维码由代表医生特异性身份的号码转化而来，而对比文件中的二维码主要是由望色诊的量化信息编码形成。综上， 本发明的与对比文件CN106725314A有较多不同之处。
综上，申请人启动了藿香正气口服液的“百万例”临床真实世界研究项目，并以此为基础开发了相应的管理***和方法。由百度百科可知，“百万”是一个数量单位，可以是实数，一般也被用来表示虚指，言数量极多。因此本发明的“百万例”实际上是一种对超大样本数据的形容。本发明解决的问题包括①用高效、低成本的方式招募百万例患者参与临床真实世界研究。②用行之有效的方法对服用藿香正气口服液等药剂后的效果、指标进行收集、统计和分析。③用大数据的方式预测或挖掘藿香正气液等药剂更多的适应性，并为其上市后的安全性追踪提供数据支撑。该项目旨在用大数据技术推动各种药剂的发展。
发明内容
针对上述存在的技术问题，本发明提供一种“百万例真实世界研究”的管理***，用于超大样本量的受试者的临床研究管理。
为了解决上述技术问题，本发明采用的技术方案为：
“百万例临床真实世界研究”的管理***，其包括：远程管理中心、多个医技招募站、多个受试者终端，以及预先分配给每个医技招募站中每个专业人员的用于招募受试者的招募设备；所述远程管理中心、多个医技招募站和多个受试者终端通过物联网相连，其中，
所述远程管理中心用于预先根据所获取到的临床试验设计需求生成多份研究表单，以及预先根据所获取到的所邀请的每个医技招募站中每个专业人员个人信息生成唯一标识所述专业人员的二维码；通过物联网向每个医技招募站派发所述研究表单和所述二维码；以及通过物联网接收所述医技招募站反馈的由受试者和专业人员填写后的研究表单；
所述医技招募站用于接收并存储所述远程管理中心所派发研究表单和二维码，以及当所述受试者对应的受试者终端通过扫描所述招募设备上的二维码与所述医技招募站建立通信连接时，向所述受试者终端派发所述研 究表单，以及接收所述受试者终端反馈的填写后的研究表单，并获取所述专业人员录入的信息以填写所述研究表单，然后通过物联网上传至所述远程管理中心；
所述招募设备用于向所述受试者展示预先配置在所述招募设备上的唯一标识所述专业人员的二维码；
所述受试者终端用于扫描所述招募设备所展示的二维码，以通过物联网与对应专业人员的所述医技招募站建立通信连接，并接收所述医技招募站通过物联网所派发的研究表单；以及获取所述受试者录入的信息以填写所述研究表单，并通过物联网将填写后的研究表单反馈至对应的所述医技招募站。
进一步地，所述受试者终端反馈的所述研究表单包括所述受试者的舌苔图像数据；则
所述管理***还包括：色差分析仪，通过物联网与所述医技招募站相连，用于检测所述医技招募站发送来的研究表单中的所述受试者舌苔图像数据的色差值，然后将检测得到的色差值反馈给所述医技招募站以在所述研究表单中进行色差值标记；和/或，
所述远程管理中心/所述医技招募站对所述受试者舌苔图像数据进行预处理，得到黑白色调的舌苔图像数据，并按照灰度值进行分类并构建舌苔图像数据库。
其中，所述远程管理中心包括：
二维码生成设备，用于获取研究发起人所邀请的每个专业人员的个人信息，并根据所述个人信息生成唯一标识所述专业人员的二维码；
研究表单生成设备，用于获取临床试验的设计需求，并根据该设计需要生成相应的研究表单；
服务器，与所述二维码生成设备和所述研究表单生成设备相连，用于存储所述研究表单和所述二维码，以及根据预先构建的医技招募站数学模型，并根据所述医技招募数学模型计算得到的医技招募站数，通过物联网 向所邀请的每个医技招募站派发相应数量的所述研究表单和对应二维码，并接收所述医技招募站反馈的由受试者和专业人员填写后的研究表单；其中，
所述医技招募站数学模型为：m＝x/n；其中，m为医技招募站的总数量，n为每个医技招募站所招募的受试者数量，x为临床试验所需受试者/研究表单总数。
其中，所述医技招募站包括：
招募服务器，用于通过物联网与所述服务器建立通信连接，以接收所述服务器所派发的所述研究表单和所述二维码；以及当所述受试者终端通过扫描所述招募设备上的二维码时，与所述受试者终端建立通信连接，以获取所述受试者终端的标识信息，并推送至医技终端；
多个医技终端，与所述招募服务器相连，用于接收所述招募服务器推送来的受试者终端标识信息，并通过所述招募服务器向所述受试者终端发送所述研究表单，以及接收所述受试者终端通过所述招募服务器反馈回来的由受试者填写后的研究表单，同时获取对应专业人员所录入的所述受试者的临床信息以填写所述研究表单，然后通过所述招募服务器将由所述专业人员和所述受试者填写后的研究表单上传至所述远程管理中心。
进一步地，所述招募服务器还用于当获取到填写有受试者个人信息研究表单时，根据所述受试者个人信息生成唯一标识所述受试者的特性编码，并标记在所述研究表单中。
其中，所述研究表单包括受试者个人信息板块、临床研究信息板块和知情同意书板块；和/或，
所述专业人员个人信息包括医生的执业证号和/或资格证号和/或身份证号和/或手机号；所述专业人员为医生、药师或护士，且所述专业人员的个人信息是由研究发起人录入所述远程管理中心的，或者由所述专业人员登录所述远程管理中心后自行录入的；和/或，
所述招募设备为所述专业人员的随身物品，所述随身物品包括眼镜和/ 或白大褂和/或和/或坐诊台和/或工作证；且所述招募设备被分配到至少10个省份/地区。
其中，所述舌苔图像数据的灰度值分类包括：A类、B类和C类，其中A类的灰度值为121-150，B类的灰度值为151-190，C类的灰度值为191-250；健康人的灰度值为90-120。
进一步地，所述服务器还用于构建受试者数据库和/或招募人员数据库。
更进一步地，所述“百万例临床真实世界研究”为针对藿香正气口服液的临床真实世界研究。
基于上述的“百万例真实世界研究”的管理***，本发明还提供了一种“百万例真实世界研究”的管理方法，其包括步骤：
远程管理中心获取临床试验设计需求，并生成相应的多份研究表单；
远程管理中心获取所邀请的每个医技招募站中每个专业人员的个人信息，并生成唯一标识所述专业人员的二维码；
远程管理中心通过物联网将所生成的研究表单和二维码发送给对应的每个医技招募站，以使得当受试者终端通过扫描所述医技招募站中专业人员对应的招募设备所展示的二维码与所述医技招募站建立通信连接后，从所述医技招募站获取所述研究表单；
远程管理中心接收医技招募站通过物联网反馈的由受试者和专业人员填写后的研究表单；
其中，所述招募设备是预先派发给每个专业人员的，且每个招募设备上预先配置有唯一标识所述专业人员的所述二维码。
进一步地，获取每个专业人员的个人信息之前，还包括步骤：
所述远程管理中心构建医技招募站数学模型，并结合研究表单总数计算医技招募站数量；其中，
所述医技招募站数学模型为：m＝x/n；其中，m为医技招募站的总数量，n为每个医技招募站所招募的受试者数量，x为临床试验所需受试者/研究表单总数。
其中，所述医技招募站发送来的所述研究表单中包括所述受试者的舌苔图像数据，且所述舌苔图像数据被标记有对应的色差值/灰度值；
其中，所述色差值是由色差分析仪对受试者终端所采集的舌苔图像数据进行检测得到，并反馈至所述医技招募站，由所述医技招募站在所述研究表单中标记的；
其中，所述灰度值是由所述医技招募站对受试者终端所采集的受试者舌苔图像数据进行预处理，得到黑白色调的舌苔图像数据后得到并在所述研究表单中标记的。
所述医技招募站发送来的所述研究表单中包括所述受试者的舌苔图像数据，则所述管理方法还包括步骤：
所述远程管理中心对各个受试者的舌苔图像数据进行预处理，得到黑白色调的舌苔图像数据，并按照灰度值进行分类并构建舌苔图像数据库。
其中，所述医技招募站发送来的所述研究表单中包括所述受试者的舌苔图像数据，则所述管理方法还包括步骤：
所述远程管理中心对各个受试者的舌苔图像数据进行预处理，得到黑白色调的舌苔图像数据，并按照灰度值进行分类并构建舌苔图像数据库。
其中，所述研究表单包括受试者个人信息板块、临床研究信息板块和知情同意书板块；和/或，
所述专业人员个人信息包括医生的执业证号和/或资格证号和/或身份证号和/或手机号；所述专业人员为医生、药师或护士；且所述专业人员的个人信息是由研究发起人录入所述远程管理中心的，或者由所述专业人员登录所述远程管理中心后自行录入的；和/或，
所述招募设备为所述专业人员的随身物品，所述随身物品包括眼镜和/或白大褂和/或和/或坐诊台和/或工作证。
其中，所述舌苔图像数据的灰度值分类包括：A类、B类和C类，其中A类的灰度值为121-150，B类的灰度值为151-190，C类的灰度值为191-250；健康人的灰度值为90-120。
进一步地，所述“百万例临床真实世界研究”为针对藿香正气口服液的临床真实世界研究。
基于上述的“百万例真实世界研究”的管理***，本发明还提供了另一种“百万例真实世界研究”的管理方法，其包括步骤：
医技招募站通过物联网与远程管理中心建立通信连接，并协助专业人员登记个人信息；
医技招募站接收所述远程管理中心通过物联网派发的研究表单和唯一标识对应专业人员的二维码；其中，所述研究表单是所述远程管理中心根据临床试验设计需求生成的，所述二维码是所述远程管理中心根据所述个人信息生成的；
医技招募站将所述研究表单下发给受试者对应的受试者终端，所述受试者终端是通过扫描所述专业人员对应的招募设备上的二维码时，通过物联网与所述医技招募站建立的通信连接；所述招募设置是预先分配给每个医技招募站中的每个专业人员的，且预先配置有唯一标识对应专业人员的二维码；
医技招募站接收所述受试者终端通过物联网反馈的由所述受试者填写后的研究表单，并获取对应专业人员所录入的临床信息以填写所述研究表单，然后将由受试者和专业人员填写后的研究表单上传至所述远程管理中心。
其中，所述受试者终端发送来的所述研究表单中包括所述受试者舌苔图像数据，且所述医技招募站向所述远程管理中心反馈所述研究表单之前，还包括步骤：
所述医技招募站对所述受试者舌苔图像数据进行预处理，得到黑白色调的舌苔图像数据，并标记相应的灰度值；和/或，
所述医技招募站将所述受试者舌苔图像数据发送至色差分析仪进行检测，并将检测得到的色差值标记在相应的所述受试者舌苔图像数据上。
基于上述的“百万例真实世界研究”的管理***，本发明还提供了另 一种“百万例真实世界研究”的管理方法，其包括步骤：
受试者终端通过扫描招募设备上的唯一标识对应专业人员的二维码，以建立与所述专业人员对应医技招募站的通信连接；其中，所述二维码是远程管理中心根据预先所获取到的专业人员个人信息生成，并预先配置在派发给所述专业人员的招募设备上的；
受试者终端通过物联网接收所述医技招募站下发的研究表单；其中，所述研究表单是远程管理中心通过物联网下发给所述医技招募站的，且是根据临床试验设计需求生成的；
受试者终端获取受试者录入的信息以填写所述研究表单，并反馈至所述医技招募站；其中，所述受试者录入的信息包括所述受试者舌苔图像数据。
进一步地，所述“百万例临床真实世界研究”为针对藿香正气口服液的临床真实世界研究。
更进一步地，所述受试者录入的信息包括所述受试者舌苔图像数据。
本发明的有益之处在于：
1)本***收集了海量数据，同时高效、低成本的实现了招募受试者的功能。2)本***可为药剂量身定制，在众多的临床体征中选取了相应的部位作为典型体征，如为藿香正气液，选取舌苔作为典型体征，***专门建立了舌苔数据库，并将海量舌苔进行了分类。3)本***在开展临床试验研究的同时，将打通100万受试者和医生、药企之间的信息屏障；***分配的二维码将成为申请人的数据财富，并进一步实现医生教育、求医问诊等需求的载体。4)本发明还能以大数据的方式预测或挖掘藿香正气液等药剂更多的适应性，并为其上市后的安全性追踪提供数据支撑。
附图说明
图1a为本发明的一种“百万例临床真实世界研究”的管理***的一实施例的功能模块示意图；
图1b为本发明的一种“百万例临床真实世界研究”的管理***的又一实施例的功能模块示意图；
图2为反应图1中管理***中受试者终端、招募服务器、医技终端和远程管理中心的服务器之间的实时交互示意图；
图3为本发明的一种“百万例临床真实世界研究”的管理方法的一实施例的流程图；
图4为招募设备的一实施例的示意图；
图5为舌苔灰度值分类示意图。
具体实施方式
下面结合附图，对本实用新型作详细的说明。
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。
名词释义
研究发起人：本文中的研究发起人是指发起藿香正气口服液或者其他“百万例临床真实世界研究”的企业，或者该企业为本文中管理***的管理者。
专业人员：文本中的专业人员是指具有专业医技的技术人员，如药师、医生或者护士等，且当其应上述研究发起人的邀约去招募患者参与“百万例临床真实世界研究”时，该专业人员则也称之为招募人员。
受试者：本文中的受试者是指藿香正气口服液或其他“百万例临床真实世界研究”中的被采集相关数据，如个人信息和舌苔图像数据，的患者，且该患者是在招募人员的号召下资源参与该研究的。
研究表单：本文中的研究表单是研究发起人针对藿香正气口服液或其他相应“百万例临床真实世界研究”设计的表单，其包括参与者(如受试 者及其对应的专业人员)信息板块、临床研究信息板块和知情同意书板块，其中，该临床信息板块包括受试者舌苔图像信息栏，以及受试者的地区、性别、年龄、体温、身高、体重、脉象、病症、用药方式等信息。
远程管理中心：本文中的远程管理中心是指由研究发起人所掌控的一套设施，其用于根据临床试验设计需求生成多份研究表单(如n份，n≥1000000)，以及根据每个专业人员个人信息生成唯一标识该专业人员的二维码；以及通过物联网下发研究表单和二维码，并接收反馈回来的由受试者和专业人员填写后的研究表单。
医技招募站：本文中的医技招募站是指用于招募受试者的某个医疗场所，如药店、药房、诊所、社区卫生站，或医院等，其配置有多个医技终端，如专业人员的办公电脑/移动终端，招募服务器，其可通过物联网与远程管理中心相连，以及可连接至该办公电脑/移动终端以反馈患者/受试者检测数据的各项医疗仪器，以及预先分配给该医技招募站中工作的每个专业人员的招募设备。其中，该招募设备是由上述远程管理中心分配给每个医技招募站，而该招募设备上配置的二维码可以是该远程管理中心预先根据每个医技招募站中专业人员信息配置好的，然后由该医技招募站根据二维码分发给对应的专业人员的；当然，该招募设备上的二维码也可以是由医技招募站从远程管理中心获取到其内的专业人员各自的二维码后，再配置到各个招募设备上，然后分发给相应的专业人员的；当然，也可以是医技招募将招募设备分发给各个专业人员后，各个专业人员从该医技终端站获取对应的二维码后直接配置到该招募设备上的。
受试者终端：本文中的受试者终端是指可通过扫描招募设备上的二维码与医技终端建立通信连接，以获取研究表单，并反馈研究表单的设备，如受试者随身的移动终端等。
本发明通过分别设置对应于研究发起人的远程管理中心，对应于专业人员(即招募人员)的多个医技招募站和多个招募设备，以及对应于受试者的受试者终端，即通过远程管理中心根据临床试验设计需要生成相应的 研究表单，并根据存储的专业人员个人信息生成唯一标识专业人员的二维码，然后通过物联网将该研究表单和二维码下发至对应的医技招募站，且当受试者的受试者终端扫描专业人员预先分配得到的招募设备，以与医技招募站建立通信连接时，该医技招募站(在专业人员的操控下)通过物联网将研究表单下发至相应的受试者终端，而当受试者终端通过物联网向医技招募站反馈受试者填写后的研究表单时，医技招募站将该研究表单推送至专业人员进行填写，并将填写后的研究表单上传至远程管理中心，即本发明的管理***链接了药厂(即研究发起人)、医生(即专业人员)、患者(即受试者)，并可实现线上线下互动等特点，因而可以预见在未来如藿香正气液等药剂的销售量将会陡然增长。
实施例一
参见图1a，为本发明的一种“百万例临床真实世界研究”的管理***的一实施例的框架原理图，具体地，以藿香正气口服液“百万例临床真实世界研究”的管理为例进行说明，本实施例中的该管理***包括：远程管理中心1、多个医技招募站2、多个受试者终端3和多个用于招募受试者的招募设备4；其中，该远程管理中心1、医技招募站2和受试者终端3均通过物联网相连。
本实施例中，该远程管理中心1用于预先根据所获取到的藿香正气口服液临床试验设计需求生成研究表单，以及预先根据所获取到的所邀请的每个专业人员个人信息生成唯一标识专业人员的二维码；通过物联网向每个专业人员对应的医技招募站派发所生成的研究表单和对应的二维码；以及通过物联网接收医技招募站反馈的由受试者填写后的研究表单。
在一具体实施例中，该远程管理中心1包括：
二维码生成设备，用于获取研究发起人所邀请的专业人员的个人信息，并根据该个人信息生成唯一标识该专业人员的二维码；
研究表单生成设备，用于获取藿香正气口服液临床试验的设计需求， 并根据该设计需要生成相应的研究表单；具体地，该研究表单生成设备可采用PC机或单片机或电脑等可供录入设计需求，并生成的表单的智能终端；
服务器，与上述的二维码生成设备和研究表单生成设备相连，用于存储研究表单和二维码，以及用于通过物联网与医技招募站建立通信连接，以向医技招募站派发研究表单和二维码，并接收医技招募站反馈的由受试者填写后的研究表单。
在一具体实施例中，该设计需求是研究发起人录入该远程管理中心的，而专业人员个人信息可以由研究发起人预先获取到所邀请的每个专业人员的个人信息，并录入该远程管理中心的，也可以是被邀请的专业人员各自通过医技招募站登录该远程管理中心，进行注册登录时所录入的。其中，该专业人员包括医生，或药师，或护士等，个人信息包括执业证号和/或资格证号和/或身份证号和/或手机号等。
在一具体实施例中，该当专业人员注册登录成功后，或者通过研究发起人分配的账号首次登录该远程管理中心后，该远程管理中心则将所生成的研究表单和对应的二维码通过物联网下发至该专业人员对应医技招募站进行存储。当然，该研究表单也可以是专业人员通过医技招募站向该远程管理中心的服务器发送下载请求后，该远程管理中心的服务器再根据该下载请求发送给医技招募站的。其中，该研究表单包括受试者个人信息板块、临床研究信息板块和知情同意书板块；该临床信息板块由受试者/专业人员来填写各种临床数据，如受试者舌苔图像数据，当然不同的药剂临床试验可能测试的部位不同，因此，该临床数据也可以是其它部位的图像数据。
进一步地，该服务器还用于根据每个专业人员的二维码构建招募人员数据库。随着参与的医疗人员数量越来越多，便可形成一个二维码数据库，也即招募人员(专业人员)数据库，从而便于优化整合更多的医疗资源，以为后续其他药品临床试验储备医疗资源，使得当进行新药品临床试验时，只需要向该招募人员数据库中的各个招募人员，即专业人员，对应的医技终端发出邀请函即可，无需重头开始到各个地区/省份招募新的专业人员， 避免了因一个产品临床试验的完成而导致因断联而造成医生资源的浪费。
本实施例中，该医技招募站用于接收并存储该远程管理中心所下发的研究表单和二维码，以及当受试者对应的受试者终端扫描上述招募设备上的二维码与该医技招募站建立通信连接时，向该受试者终端下发研究表单，然后接收该受试者终端反馈的由受试者填写完整的研究表单，并通过物联网上传至远程管理中心。
在一具体实施例中，该医技招募站包括：
招募服务器，通过物联网与远程管理中心的服务器建立通信连接，用于接收存储该服务器下发的研究表单和二维码；以及当受试者对应的受试者终端通过扫描招募设备上的二维码时，与受试者终端建立通信连接，并获取该受试者终端的标识信息(如手机号码)，然后将该标识信息发送给医技终端，并在医技终端的控制指令下将所存储的研究表单发送给该受试者终端；
多个医技终端，与该招募服务器相连，用于接收招募服务器发送来的受试者终端标识信息，并通过该招募服务器发送研究表单至该受试者终端，以及接收受试者终端通过招募服务器反馈回来的由受试者填写后的研究表单，并获取专业人员录入的临床信息(如针对该受试者终端对应的受试者的诊疗信息)以填写该研究表单，然后通过该招募服务器将专业人员和受试者填写后的研究表单上传至远程管理中心。
在一具体实施例中，当专业人员通过在该医技终端上输入相应的远程管理中心的网址或通过扫描相应的二维码进入该远程管理中心时，则该医技终端通过招募服务器与该远程管理中心的服务器建立通信连接，而当其进行注册登记完成后，或者利用研究发起人分配的账号首次登录该远程管理中心时，则该远程管理中心即将预先生成的研究表单和根据该专业人员个人信息生成的二维码下发给该专业人员对应医技招募站的招募服务器进行存储。
在一具体实施例中，招募设备是专业人员的随身物品，具体包括眼镜 和/或白大褂和/或和/或坐诊台和/或工作证，且该招募设备是由研究发起人向自己所邀请的医技招募站(具体地，可直接通过在远程管理中心上向连接至服务器的各个医技招募站发送携带有详细项目介绍的邀请函；当然也可面对面邀请)派发的，具体招募设备数量是根据该医技招募站中作为招募人员的数量派发的，而该招募设备上的二维码可以是该远程管理中心派发招募设备时就已经配置在该招募设备上的，也可以是医技招募站在接收到二维码时自行配置在所分配的招募设备上的，也可以是专业人员从医技招募站获取到二维码后自行配置在招募设备上的。而当受试者通过受试者终端扫描招募设备上的二维码时，则该受试者终端即建立起与该二维码对应的专业人员的招募服务器的通信连接，同时，该招募服务器也将获取到该受试者终端的信息，如电话号码，从而受试者信息推送至医技终端，并根据医技终端反馈的支路将所存储的研究表单发送给该受试者终端。
进一步地，该招募设备被分派到至少10个不同的省份/地区，从而能够收集到多元的患者样本。
更进一步地，由于我国幅员辽阔，南北地区气候差异巨大：北方地区夏季炎热,冬季低温,气温年较差大；南方地区夏季高温,冬季温暖,气温年较差较北方小，这就使得南北患者的患病与用药情况也必有差异，因此，本实施例中该招募设备根据不同季节被分配至不同的省份/地区，以收集不同省份/地区的受试者数据，实现患者样本的多样化的同时，还能够在不同气候带不同地区形成独有的用药体系，具有重大意义。
进一步地，上述招募服务器还用于当获取到填写有受试者个人信息研究表单时，根据受试者个人信息生成唯一标识受试者的特性编码，并标记在研究表单中。
更进一步地，本实施例中，当医技招募站的招募服务器/医技终端接收到受试者终端反馈来的研究表单后，则对该研究表单进行预处理，如招募服务器自动调取Photoshop等制图软件(或医技终端在专业人员的操控下调取Photoshop等制图软件)将受试者舌苔图像数据转换为黑白色调，然 后获取其灰度值并在研究表单中进行标记，然后发送给远程管理中心以按照灰度值进行分类并构建舌苔图像数据库；当然，也可以是直接将黑白色调的受试者舌苔数据直接发送给远程管理中心，由该远程管理中心来进行灰度值的获取和标记，然后按照灰度值进行分类并构建舌苔图像数据库。其中，该舌苔图像数据的灰度值分类具体包括：A类、B类和C类，其中A类的灰度值为121-150，B类的灰度值为151-190，C类的灰度值为191-250；健康人的灰度值为90-120。
本实施例中，该受试者终端4用于扫描招募设备所展示的二维码，以通过物联网与该招募设备对应的专业人员的医技招募站中招募服务器建立通信连接(具体地，参见图2，扫码后向招募服务器发送通信连接请求，并接收招募服务器的响应以建立通信连接；其中，该通信连接请求中携带有受试者终端的标识信息)，并接收该招募服务器下发的研究表单(具体地，参见图2，由医技终端接收到受试者终端标识信息后，向该招募服务器发送向该受试者终端下发表单请求，然后该招募服务器向该受试者终端下发研究表单)；以及获取该受试者录入的信息以填写所接收到的研究表单，并通过物联网将填写后的研究表单反馈至该医技招募站中招募服务器。
在一具体实施例中，该受试者录入的信息包括受试者的个人信息，如地区、性别、年龄、身高、体重等信息，以及舌苔图像数据。其中，该舌苔图像数据的受试者直接选取该研究表单中舌苔图像信息栏中的拍照功能选项，然后调用该受试者终端上的拍照模块进行拍照得到的，或者，受试者直接开启受试者终端上的拍照模块进行拍照，然后点击舌苔图像信息栏中的上传/添加功能选项后直接选中所拍摄的舌苔图像数据，当然，也可以是受试者采用另外的拍照设备拍照后通过无线/有线的方式加载到该舌苔图像信息栏的，而该拍照设备可以是由远程管理中心派发给专业人员，然后由专业人员分发给各个受试者的。
下面以微信平台为例，对本实施例的该管理***的工作原理进行详细的说明：
1、医生和/或药师和/或护士在手机(即医技终端)微信平台上搜索公众号，进入“太极藿香正气官方服务号”(即登录远程管理中心的服务器)；当然，也可以是通过扫描该太极藿香正气官方服务号的二维码进入的；
2、医生和/或药师和/或护士(即专业人员)在“太极藿香正气官方服务号”(即远程管理中心的服务器)进行注册登记个人信息；该个人信息包括医技招募站的设备标识号，如电话号码；在注册登记个人信息时，要求必须上传医师执业证书照片，包括姓名页和执业地址页，不可用医师资格证书代替；
3、远程管理中心的二维码生成设备根据个人信息生成唯一标识该专业人员的二维码，而服务器则将该二维码和预先生成的研究表单一起派发给专业人员所在医技招募站的招募服务器；同时，医技招募站接收到二维码后，则将每个专业人员的二维码配置到预先分配得到的工作牌(即招募设备)上，然后派发给相应的专业人员以随身携带；
4、患者(即受试者)通过随身携带的移动终端(即受试者终端)扫描该专业人员工作牌(即招募设备)上的二维码，以与医生和/或药师和/或护士的手机(即医技终端)建立通信连接；
5、医生和/或药师和/或护士的手机通过招募服务器获取到患者移动终端的标识信息(如电话号码)；
6、医生和/或药师和/或护士通过手机向招募服务器发送下发表单的请求，使得招募服务器向患者的移动终端推送研究表单，该研究表单包括电子知情同意书，参与人(专业人员和受试者)基本信息表单，以及医生初诊问卷、患者日志问卷、不良事件跟踪问卷和严重不良事件跟踪问卷等临床研究信息相关表单；
7、患者在移动终端(即受试者终端)上查阅电子知情同意书，并确定知情同意；
8、医生和/或药师和/或护士在医技终端填写患者初诊问卷；
9、患者在移动终端(即受试者终端)填写日志问卷，并通过招募服务 器反馈至医技终端；
10、医生和/或药师和/或护士通过医技终端在招募服务器上查阅患者日志并跟踪患者情况；
11、招募服务器根据研究表单生成AE和SAE的记录报告。
AE和SAE的记录报告主要包括以下：
首先，AE记录报告，当患者在研究表单的日志问卷中填写了特殊不适情况时，则该招募服务器根据研究表单所填写的特殊不适情况生成一条AE记录，并创建AE库，以列表形式推送至医技终端，以使得医生对AE进行跟踪随访。
最后，SAE记录报告，当医生在医技终端中判断出对所生成的AE记录属于以下情况之一时，则招募服务器将该AE记录标记为SAE。
BL11：患者的不适情况是否导致以下情况发生？(备注：如果有任何一种情况，请在SAE中完善SAE报告填写内容。)(非必填多选题)
□致死
□危机生命
□导致住院或延长住院时间
□导致显著或者永久的人体伤残或者器官功能的损伤
□致畸、致癌、致出生缺陷
□其他药剂的医学事件
实施例二
参见图1b，为本发明的另外一种“百万例临床真实世界研究”的管理***的一实施例的框架原理图，具体地，本实施例的该管理***包括上述实施例一中的各个模块，不同的是，本实施例的该管理***还包括：
色差分析仪，其通过物联网与医技招募站的招募服务器相连，用于检测医技招募站中的招募服务器发送来的研究表单中的受试者舌苔图像数据，并将检测得到的色差值反馈给医技招募站的招募服务器，然后由该招募服 务器在研究表单中进行色差值标记。
相应地，该招募服务器和/或，远程管理中心接收到标记有色差值的舌苔图像数据后，还可构建相应的舌苔图像数据库。
当然，本实施例中，该受试者舌苔图像数据也可以是由受试者终端直接通过物联网发送给该色差分析仪进行检测的；而在另一具体实施例中，该色差仪还可将检测结果发送到远程管理中心的服务器，然后由该远程管理中心的服务器进行标记，并构建相应的舌苔图像数据库。
当然，本实施例中，该色差分析仪的数量可根据实际情况确定，可以是每个医技招募站处设置一个，也可以只设置一个。
实施例三
基于上述实施例一中的“百万例临床真实世界研究”的管理***，本发明还提供了一种“百万例临床真实世界研究”的管理方法，下面以藿香蒸汽口服液“百万例临床真实世界研究”为例进行说明，结合具体的实施例进行详细的说明。
参见图3，本实施例的“百万例临床真实世界研究”的管理方法具体包括步骤：
步骤一，远程管理中心获取临床试验设计需求，并生成相应的研究表单。
本实施例中，该设计需求是研究发起人录入该远程管理中心的，具体地，该设计需求包括该临床试验中所需受试者数量，参与者信息，临床研究内容等，则生成的该研究表单包括医生个人信息板块、受试者个人信息板块、知情同意书板块、医生初诊问卷、患者日志问卷、不良事件跟踪问卷和严重不良事件跟踪问卷等临床信息研究板块，以供受试者上传舌苔图像数据等临床数据。
步骤二，远程管理中心获取所邀请的每个医技招募站中每个专业人员的个人信息，并生成唯一标识所述专业人员的二维码。
本实施例中，获取每个专业人员的个人信息之前，该远程管理中心需 要构建医技招募站数学模型，即结合临床试验设计需求，设置相应的数量的医技招募站，并设定每个医技招募站所招募的受试者数量，得到医技招募站数学模型为：m＝x/n；其中，m为医技招募站的总数量，n为每个医技招募站所招募的受试者数量，x为临床试验所需受试者/研究表单总数；然后获取所邀请的每个医技招募站中专业人员的个人信息。而专业人员个人信息可以由研究发起人预先获取到所邀请的每个专业人员的个人信息(例如专业人员/医技招募站所提交的招募人员信息)，并录入该远程管理中心的，也可以是被邀请的专业人员各自通过医技招募站的医技终端登录该远程管理中心，进行在线注册登录时所录入的。其中，该专业人员包括医生，或药师，或护士等，个人信息包括执业证号和/或资格证号和/或身份证号和/或手机号等。
步骤三，远程管理中心通过物联网将所生成的研究表单和二维码发送个对应的每个医技招募站，以使得受试者终端通过扫描该医技招募站中每个专业人员对应的招募设备所展示的二维码与该医技招募站中的招募服务器建立通信连接，从而从该招募服务器中获取研究表单。
在一具体实施例中，该当专业人员注册登录成功后，或者通过研究发起人分配的账号首次登录该远程管理中心后，该远程管理中心则将所生成的研究表单和对应的二维码通过物联网下发至该专业人员对应医技招募站进行存储。当然，该研究表单也可以是专业人员通过医技招募站向该远程管理中心的服务器发送下载请求后，该远程管理中心的服务器再根据该下载请求发送给医技招募站的。其中，该研究表单包括专业人员个人信息板块、受试者个人信息板块、临床研究信息板块和知情同意书板块；该临床信息板块包括受试者舌苔图像信息栏。
步骤四，远程管理中心接收医技招募站通过物联网反馈的由受试者和专业人员填写后的研究表单。
在一具体实施例中，当受试者通过受试者终端扫描预先分配给专业人员的招募设备上的唯一标识该专业人员二维码时，则该受试者终端即建立 起与该二维码对应的专业人员的医技招募站中招募服务器的通信连接，同时，该医技招募站中的招募服务器也将获取到该受试者终端的标识信息，如电话号码，从而该受试者终端可将受试者填写后的研究表单通过物联网上传至医技招募站的招募服务器，然后由招募服务器转发给医技终端，继续由专业人员进行填写，且填写完成后，由招募服务器将其转发给远程管理中心。
在一具体实施例中，该招募设备是专业人员的随身物品，具体包括眼镜和/或白大褂(参见图4)和/或和/或坐诊台和/或工作证，且该招募设备是由研究发起人向自己所邀请的医技招募站(具体地，可直接通过在远程管理中心上向连接至服务器的各个医技招募站发送携带有详细项目介绍的邀请函；当然也可面对面邀请)派发的，具体招募设备数量是根据该医技招募站中作为招募人员的数量派发的，而该招募设备上的二维码可以是该远程管理中心派发招募设备时就已经配置在该招募设备上的，也可以是医技招募站在接收到二维码时自行配置在所分配的招募设备上的，也可以是专业人员从医技招募站获取到二维码后自行配置在招募设备上的。而当受试者通过受试者终端扫描招募设备上的二维码时，则该受试者终端即建立起与该二维码对应的专业人员的招募服务器的通信连接，同时，该招募服务器也将获取到该受试者终端的信息，如电话号码，从而受试者信息推送至医技终端，并根据医技终端反馈的支路将所存储的研究表单发送给该受试者终端。
进一步地，本实施例中，当远程管理中心接收到填写有受试者舌苔图像数据的研究表单时，还包括步骤：
远程管理中心对舌苔图像数据进行预处理，得到黑白色调的舌苔图像数据，并按照灰度值进行分类，以及构建舌苔图像数据库。
在一具体实施例中，可采用Photoshop等软件进行预处理；而舌苔图像数据的灰度值分类包括：A类、B类和C类，其中A类的灰度值为121-150，B类的灰度值为151-190，C类的灰度值为191-250；健康人的灰度值为 90-120，参见图5。
实施例四
基于上述实施例二中的“百万例临床真实世界研究”的管理***，本发明还提供了另外一种“百万例临床真实世界研究”的管理方法，其包括上述实施例三中的各个步骤，不同的是，本实施例中，该远程管理中心并不需要对所接收的舌苔图像数据进行预处理以获取灰度值，因为该远程管理中心的服务器所接收到的舌苔图像数据已经被标记了相应的灰度值/色差值。
在一具体实施例中，该色差值是由医技招募站的招募服务器/受试者终端将舌苔图像数据发送给色差分析仪进行检测得到，并由该色差仪通过物联网反馈至该医技招募站的招募服务器/医技终端，然后由医技招募站的招募服务器/医技终端在研究表单中标记的；而该灰度值则是由医技招募站中的招募服务器/医技终端对受试者终端所采集的受试者舌苔图像数据进行预处理，得到黑白色调的舌苔图像数据后得到并在研究表单中标记的。
实施例五
基于上述实施例一中的“百万例临床真实世界研究”的管理***，本发明还提供了另一种“百万例临床真实世界研究”的管理方法，下面结合具体的实施例进行详细的说明。
本实施例的“百万例临床真实世界研究”的管理方法具体包括步骤：
步骤一，医技招募站通过物联网与远程管理中心建立通信连接，并协助专业人员登记个人信息。
在一具体实施例中，该医技招募站包括相连的招募服务器和多个医技终端，其中，招募服务器通过物联网与远程管理中心的服务器建立通信连接，用于接收存储该服务器下发的研究表单和二维码；以及当受试者对应的受试者终端通过扫描招募设备上的二维码时，与受试者终端建立通信连接，并获取该受试者终端的标识信息(如手机号码)，然后将该标识信息 发送给医技终端，并在医技终端的控制指令下将所存储的研究表单发送给该受试者终端；医技终端，与该招募服务器相连，用于接收招募服务器发送来的受试者终端标识信息，并通过该招募服务器发送研究表单至该受试者终端，以及接收受试者终端通过招募服务器反馈回来的由受试者填写后的研究表单，并获取专业人员录入的临床信息(如针对该受试者终端对应的受试者的诊疗信息)以填写该研究表单，然后通过该招募服务器将专业人员和受试者填写后的研究表单上传至远程管理中心。
在一具体实施例中，当专业人员通过在该医技招募站中的医技终端上输入相应的远程管理中心的网址或通过扫描相应的二维码进入该远程管理中心时，该医技终端通过招募服务器与该远程管理中心的服务器建立通信连接，从而使得专业人员可通过该医技终端直接在该远程管理中心上进行注册，并登记个人信息。其中，专业人员个人信息包括执业证号和/或资格证号和/或身份证号和/或手机号；专业人员为医生、药师或护士。
步骤二，医技招募站接收远程管理中心通过物联网派发的研究表单和唯一标识对应专业人员的二维码。
本实施例中，该研究表单是远程管理中心根据临床试验设计需求(与上述实施例一或二中的相同)生成的，而该二维码是远程管理中心根据步骤一中所登记的个人信息生成的。
在一具体实施例中，当专业人员注册登录成功后，该远程管理中心则将预先生成的研究表单，以及根据专业人员登记的个人信息生成的二维码通过物联网下发至该专业人员对应医技招募站中的招募服务器进行存储。
当然，在另一具体实施例中该研究表单也可以是专业人员通过医技招募站的医技终端向该远程管理中心的服务器发送下载请求后，该远程管理中心的服务器再根据该下载请求发送给医技招募站的招募服务器。其中，该研究表单包括受试者个人信息板块、临床研究信息板块和知情同意书板块；该临床信息板块包括受试者舌苔图像信息栏。
步骤三，医技招募站将研究表单下发给受试者对应的受试者终端。
本实施例中，该受试者终端是通过扫描专业人员对应的招募设备上唯一标识该专业人员的二维码时，通过物联网与该医技招募站中的招募服务器建立的通信连接；而该招募设备是由研究发起人/专业人员所选定的，具体为可作为专业人员随身物品的设备，包括眼镜和/或白大褂和/或和/或坐诊台和/或工作证，并预先分发给各个医技招募站的，而该招募设备上的二维码则是由远程管理中心将每个专业人员对应的二维码配置到招募设备上的，或者，是由医技招募站在接收到远程管理中心下发的二维码时，由医技招募站的工作人员，如专业人员，直接将该二维码打印出来并配置在该招募设备上的。
步骤四，医技招募站接收受试者终端通过物联网反馈的由受试者填写后的研究表单，并获取对应专业人员所录入的临床信息(如初诊信息等)以填写研究表单，然后上传至远程管理中心。
在一具体实施例中，当受试者通过受试者终端收到研究表单后，则开始按照要求填写该研究表单，然后反馈至医技招募站的招募服务器，例如填写受试者的个人信息，如地区、性别、年龄、体温、身高、体重等信息，以及舌苔图像数据，其中，该舌苔图像数据的受试者直接选取该研究表单中舌苔图像信息栏中的拍照功能选项，然后调用该受试者终端上的拍照模块进行拍照得到的，或者，受试者直接开启受试者终端上的拍照模块进行拍照，然后点击舌苔图像信息栏中的上传/添加功能选项后直接选中所拍摄的舌苔图像数据，当然，也可以是受试者采用另外的拍照设备拍照后通过无线/有线的方式加载到该舌苔图像信息栏的，而该拍照设备可以是由远程管理中心派发给专业人员，然后由专业人员分发给各个受试者的。
进一步地，本实施例中，在接收到受试者终端反馈来的研究表单后，还包括步骤：
医技招募站还对各个受试者的舌苔图像数据进行预处理，得到黑白色调的舌苔图像数据，然后获取所述黑白色调的舌苔图像的灰度值，并反馈至远程管理中心。
在一具体实施例中，该舌苔图像数据是由该招募服务器自动调取Photoshop等制图软件将该舌苔图像数据进行色调调整的，或者由专业人员在医技终端进行操作，如调用Photoshop等软件进行预处理后得到的；而该舌苔图像数据的灰度值分类包括：A类、B类和C类，其中A类的灰度值为121-150，B类的灰度值为151-190，C类的灰度值为191-250；健康人的灰度值为90-120。
实施例六
基于上述实施例二中的“百万例临床真实世界研究”的管理***，本发明还提供了另外一种“百万例临床真实世界研究”的管理方法，其包括上述实施例五中的各个步骤，不同的是，本实施例中，医技招募站接收到舌苔图像数据不需要对其进行预处理，而是通过物联网将该受试者舌苔图像数据发送至预先配置的色差分析仪进行检测，并将色差仪所检测得到的色差值标记在相应的受试者舌苔图像数据上。
在一具体实施例中，该色医技招募站的招募服务器通过物联网将舌苔图像数据发送给预先配置好的色差分析仪进行检测，然后接收该色差分析仪反馈回来的检测结果，并将检测结果在研究表单中进行标记。
实施例七
基于上述实施例一中的“百万例临床真实世界研究”的管理***，本发明还提供了另一种“百万例临床真实世界研究”的管理方法，下面结合具体的实施例进行详细的说明。
本实施例的“百万例临床真实世界研究”的管理方法具体包括步骤：
步骤一，受试者终端通过扫描招募设备上的唯一标识对应专业人员的二维码，以建立与所述专业人员对应医技招募站的通信连接。
在一具体实施例中，该二维码是远程管理中心根据所获取到的专业人员个人信息生成，并预先配置在招募设备上的，或者由医技招募站在接收 到远程管理中心下发的二维码时配置到研究发起人预先分配来的招募设备上；而该招募设备采用的是可作为专业人员随身物品的设备，具体包括眼镜和/或白大褂和/或和/或坐诊台和/或工作证；其中，专业人员个人信息是由研究发起人预先获取到所邀请的每个专业人员的个人信息，并录入该远程管理中心的，也可以是被邀请的专业人员各自通过医技招募站登录该远程管理中心，进行注册时所录入的，具体地，专业人员包括医生，或药师，或护士等，个人信息包括执业证号和/或资格证号和/或身份证号和/或手机号等。
步骤二，受试者终端通过物联网接收医技招募站下发的研究表单。
在一具体实施例中，该研究表单是远程管理中心通过物联网下发给医技招募站中招募服务器的，且是根据临床试验设计需求生成的，而该研究表单是专业人员在远程管理中心注册成功后，或者通过研究发起人分配的账号首次登录该远程管理中心后，该远程管理中心通过物联网下发至该专业人员对应医技招募站中招募服务器的；当然，该研究表单也可以是专业人员通过医技招募站向该远程管理中心的服务器发送下载请求后，该远程管理中心的服务器再根据该下载请求发送给医技招募站的。具体地，该研究表单包括受试者个人信息板块、临床研究信息板块和知情同意书板块；该临床信息板块包括受试者舌苔图像信息栏。
步骤三，受试者终端获取受试者录入的信息以填写研究表单，并反馈至所述医技招募站。
在一具体实施例中，该受试者在受试者终端上录入的信息包括受试者舌苔图像数据。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。

Claims (22)

  1. “百万例临床真实世界研究”的管理***，其特征在于，包括：远程管理中心(1)、多个医技招募站(2)、多个受试者终端(3)，以及预先分配给每个医技招募站中每个专业人员的招募设备(4)；所述远程管理中心(1)、多个医技招募站(2)和多个受试者终端(3)通过物联网相连，其中，
    所述远程管理中心(1)用于预先根据所获取到的临床试验设计需求生成多份研究表单，以及预先根据所获取到的所邀请的每个医技招募站中每个专业人员个人信息生成唯一标识所述专业人员的二维码；通过物联网向每个医技招募站派发所述研究表单和所述二维码；以及通过物联网接收所述医技招募站反馈的由受试者和专业人员填写后的研究表单；
    所述医技招募站(2)用于接收并存储所述远程管理中心所派发研究表单和二维码，以及当所述受试者对应的受试者终端通过扫描所述招募设备上的二维码与所述医技招募站建立通信连接时，向所述受试者终端派发所述研究表单，以及接收所述受试者终端反馈的填写后的研究表单，并获取所述专业人员录入的信息以填写所述研究表单，然后通过物联网上传至所述远程管理中心；
    所述招募设备(4)用于向所述受试者展示预先配置在所述招募设备上的唯一标识所述专业人员的二维码；
    所述受试者终端(3)用于扫描所述招募设备所展示的二维码，以通过物联网与对应专业人员的所述医技招募站建立通信连接，并接收所述医技招募站通过物联网所派发的研究表单；以及获取所述受试者录入的信息以填写所述研究表单，并通过物联网将填写后的研究表单反馈至对应的所述医技招募站。
  2. 如权利要求1所述的管理***，其特征在于，所述受试者终端反馈的所述研究表单包括所述受试者的舌苔图像数据；则
    所述管理***还包括：色差分析仪，通过物联网与所述医技招募站相连，用于检测所述医技招募站发送来的研究表单中的所述受试者舌苔图像数据的色 差值，然后将检测得到的色差值反馈给所述医技招募站以在所述研究表单中进行色差值标记；和/或，
    所述远程管理中心/所述医技招募站对所述受试者舌苔图像数据进行预处理，得到黑白色调的舌苔图像数据，并按照灰度值进行分类并构建舌苔图像数据库。
  3. 如权利要求2所述的管理***，其特征在于，所述远程管理中心包括：
    二维码生成设备，用于获取每个专业人员的个人信息，并根据所述个人信息生成唯一标识所述专业人员的二维码；
    研究表单生成设备，用于获取临床试验的设计需求，并根据所述设计需要生成相应的研究表单；
    服务器，与所述二维码生成设备和所述研究表单生成设备相连，用于存储所述研究表单和所述二维码，以及构建医技招募站数学模型，并根据所述医技招募数学模型计算得到的医技招募站数，通过物联网向每个医技招募站派发相应数量的所述研究表单和对应二维码，并接收所述医技招募站反馈的由受试者和专业人员填写后的研究表单；其中，
    所述医技招募站数学模型为：m＝x/n；其中，m为医技招募站的总数量，n为每个医技招募站所招募的受试者数量，x为临床试验所需受试者/研究表单总数。
  4. 如权利要求3所述的管理***，其特征在于，所述医技招募站包括：
    招募服务器，用于通过物联网与所述服务器建立通信连接，以接收所述服务器所派发的所述研究表单和所述二维码；以及当所述受试者终端通过扫描所述招募设备上的二维码时，与所述受试者终端建立通信连接，以获取所述受试者终端的标识信息，并推送至医技终端；
    多个医技终端，与所述招募服务器相连，用于接收所述招募服务器推送来的受试者终端标识信息，并通过所述招募服务器向所述受试者终端发送所述研 究表单，以及接收所述受试者终端通过所述招募服务器反馈回来的由受试者填写后的研究表单，同时获取对应专业人员所录入的所述受试者的临床信息以填写所述研究表单，然后通过所述招募服务器将由所述专业人员和所述受试者填写后的研究表单上传至所述远程管理中心。
  5. 如权利要求4所述的管理***，其特征在于，所述招募服务器还用于当获取到填写有受试者个人信息研究表单时，根据所述受试者个人信息生成唯一标识所述受试者的特性编码，并标记在所述研究表单中。
  6. 如权利要求2至5中任意一项所述的管理***，其特征在于，所述研究表单包括受试者个人信息板块、临床研究信息板块和知情同意书板块；和/或，
    所述专业人员个人信息包括医生的执业证号和/或资格证号和/或身份证号和/或手机号；所述专业人员为医生、药师或护士，且所述专业人员的个人信息是由研究发起人录入所述远程管理中心的，或者由所述专业人员登录所述远程管理中心后自行录入的；和/或，
    所述招募设备为所述专业人员的随身物品，所述随身物品包括眼镜和/或白大褂和/或和/或坐诊台和/或工作证；且所述招募设备被分配到至少10个省份/地区。
  7. 如权利要求6所述的管理***，其特征在于，所述舌苔图像数据的灰度值分类包括：A类、B类和C类，其中A类的灰度值为121-150，B类的灰度值为151-190，C类的灰度值为191-250；健康人的灰度值为90-120；和/或，
    所述服务器还用于构建受试者数据库和/或招募人员数据库。
  8. 如权利要求7所述的管理***，其特征在于，所述“百万例临床真实世界研究”为针对藿香正气口服液的临床真实世界研究。
  9. “百万例临床真实世界研究”的管理方法，其特征在于，基于如权利要求1至7中任意一项所述的管理***，所述方法包括步骤：
    远程管理中心获取临床试验设计需求，并生成相应的多份研究表单；
    远程管理中心获取所邀请的每个医技招募站中每个专业人员的个人信息，并生成唯一标识所述专业人员的二维码；
    远程管理中心通过物联网将所生成的研究表单和二维码发送给对应的每个医技招募站，以使得当受试者终端通过扫描所述医技招募站中专业人员对应的招募设备所展示的二维码与所述医技招募站建立通信连接后，从所述医技招募站获取所述研究表单；
    远程管理中心接收医技招募站通过物联网反馈的由受试者和专业人员填写后的研究表单；
    其中，所述招募设备是预先派发给每个专业人员的，且每个招募设备上预先配置有唯一标识所述专业人员的所述二维码。
  10. 如权利要求9所述的管理方法，其特征在于，获取每个专业人员的个人信息之前，还包括步骤：
    所述远程管理中心构建医技招募站数学模型，并结合研究表单总数计算医技招募站数量；其中，
    所述医技招募站数学模型为：m＝x/n；其中，m为医技招募站的总数量，n为每个医技招募站所招募的受试者数量，x为临床试验所需受试者/研究表单总数。
  11. 如权利要求10所述的管理方法，其特征在于，所述医技招募站发送来的所述研究表单中包括所述受试者的舌苔图像数据，且所述舌苔图像数据被标记有对应的色差值/灰度值；
    其中，所述色差值是由色差分析仪对受试者终端所采集的舌苔图像数据进行检测得到，并反馈至所述医技招募站，由所述医技招募站在所述研究表单中标记的；
    其中，所述灰度值是由所述医技招募站对受试者终端所采集的受试者舌苔图像数据进行预处理，得到黑白色调的舌苔图像数据后得到并在所述研究表单中标记的。
  12. 如权利要求10所述的管理方法，其特征在于，所述医技招募站发送来的所述研究表单中包括所述受试者的舌苔图像数据，则所述管理方法还包括步骤：
    所述远程管理中心对各个受试者的舌苔图像数据进行预处理，得到黑白色调的舌苔图像数据，并按照灰度值进行分类并构建舌苔图像数据库。
  13. 如权利要求9至12中任意一项所述的管理方法，其特征在于，所述研究表单包括受试者个人信息板块、临床研究信息板块和知情同意书板块；和/或，
    所述专业人员个人信息包括医生的执业证号和/或资格证号和/或身份证号和/或手机号；所述专业人员为医生、药师或护士；且所述专业人员的个人信息是由研究发起人录入所述远程管理中心的，或者由所述专业人员登录所述远程管理中心后自行录入的；和/或，
    所述招募设备为所述专业人员的随身物品，所述随身物品包括眼镜和/或白大褂和/或和/或坐诊台和/或工作证。
  14. 如权利要求12所述的管理方法，其特征在于，所述舌苔图像数据的灰度值分类包括：A类、B类和C类，其中A类的灰度值为121-150，B类的灰度值为151-190，C类的灰度值为191-250；健康人的灰度值为90-120。
  15. 如权利要求9至14中任意一项所述的管理方法，其特征在于，所述“百万例临床真实世界研究”为针对藿香正气口服液的临床真实世界研究。
  16. “百万例临床真实世界研究”的管理方法，其特征在于，基于如权利要 求1至7中任意一项所述的管理***，所述管理方法包括步骤：
    医技招募站通过物联网与远程管理中心建立通信连接，并协助专业人员登记个人信息；
    医技招募站接收所述远程管理中心通过物联网派发的研究表单和唯一标识对应专业人员的二维码；其中，所述研究表单是所述远程管理中心根据临床试验设计需求生成的，所述二维码是所述远程管理中心根据所述个人信息生成的；
    医技招募站将所述研究表单下发给受试者对应的受试者终端，所述受试者终端是通过扫描所述专业人员对应的招募设备上的二维码时，通过物联网与所述医技招募站建立的通信连接；所述招募设备是预先分配给每个医技招募站中的每个专业人员的，且预先配置有唯一标识对应专业人员的二维码；
    医技招募站接收所述受试者终端通过物联网反馈的由所述受试者填写后的研究表单，并获取对应专业人员所录入的临床信息以填写所述研究表单，然后将由受试者和专业人员填写后的研究表单上传至所述远程管理中心。
  17. 如权利要求16所述的管理方法，其特征在于，所述受试者终端发送来的所述研究表单中包括所述受试者舌苔图像数据，且所述医技招募站向所述远程管理中心反馈所述研究表单之前，还包括步骤：
    所述医技招募站对所述受试者舌苔图像数据进行预处理，得到黑白色调的舌苔图像数据，并标记相应的灰度值；和/或，
    所述医技招募站将所述受试者舌苔图像数据发送至色差分析仪进行检测，并将检测得到的色差值标记在相应的所述受试者舌苔图像数据上。
  18. 如权利要求17所述的管理方法，其特征在于，所述研究表单包括受试者个人信息板块、临床研究信息板块和知情同意书板块；和/或，
    所述专业人员个人信息包括医生的执业证号和/或资格证号和/或身份证号和/或手机号；所述专业人员为医生、药师或护士；和/或，
    所述招募设备为所述专业人员的随身物品，所述随身物品包括眼镜和/或白 大褂和/或和/或坐诊台和/或工作证。
  19. 如权利要求16至18中任意一项所述的管理方法，其特征在于，所述“百万例临床真实世界研究”为针对藿香正气口服液的临床真实世界研究。
  20. “百万例临床真实世界研究”的管理方法，其特征在于，基于如权利要求1至7中任意一项所述的***，所述方法包括步骤：
    受试者终端通过扫描招募设备上的唯一标识对应专业人员的二维码，以建立与所述专业人员对应医技招募站的通信连接；其中，所述二维码是远程管理中心根据预先所获取到的专业人员个人信息生成，并预先配置在派发给所述专业人员的招募设备上的；
    受试者终端通过物联网接收所述医技招募站下发的研究表单；其中，所述研究表单是远程管理中心通过物联网下发给所述医技招募站的，且是根据临床试验设计需求生成的；
    受试者终端获取受试者录入的信息以填写所述研究表单，并反馈至所述医技招募站。
  21. 如权利要求20所述的管理方法，其特征在于，所述“百万例临床真实世界研究”为针对藿香正气口服液的临床真实世界研究。
  22. 如权利要求21所述的管理方法，其特征在于，所述受试者录入的信息包括所述受试者舌苔图像数据。
PCT/CN2019/087345 2018-08-09 2019-05-17 "百万例临床真实世界研究"的管理***及方法 WO2020029633A1 (zh)

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