Method for establishing distributed clinical test system

Abstract

The invention provides a method for establishing a distributed clinical test system, which is used for setting a subject recording node and comprises the following steps of: designing a distributed account book system based on a block chain technology; the subject recording node determines the content and format of subject information data needing to be synchronized; designing a smart contract; a subject recording node is operated on a computer or a server, and the subject recording node can communicate with other nodes; the corresponding subject recording node can submit a transaction request of information modification through an intelligent contract; the subject information comprises a subject basic information module, a subject inspection information module, a subject examination information module, a subject medication information module, a subject treatment information module, a subject follow-up information module and a subject recruitment module; and the block chain technology is utilized to realize synchronous modification and storage of information among the recorded nodes of the subjects. The distributed clinical test system has high reliability, safety and transparency.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of drug clinical trials, in particular to a distributed and decentralized clinical trial system. BACKGROUND

[0002] With the rapid development of global medical technology, various new drugs are emerging, combination drug use is increasing, and irrational drug use is widespread. In recent years, drug adverse events and drug-induced diseases have occurred frequently, causing great harm to subjects and society. The current processing of new drug clinical trial information uses traditional manual methods, from research initiation, trial recording to completion of declaration and registration, through manual recording, paper submission and written review, resulting in significant consumption of manpower, material resources, financial resources and time. At the same time, the reliability, safety, accuracy and completeness of the data cannot be effectively guaranteed, and the data information utilization rate is low.

[0003] The invention with application number CN202111676996.4 provides a clinical trial project data generation method, which includes: determining the clinical attribute index of the target clinical trial project; wherein the clinical attribute index is used to represent the execution state of the target clinical trial project, and the clinical attribute index has a value constraint condition; target clinical trial data meeting the value constraint condition is selected from existing clinical trial data generated by clinical trial projects; and a target value of the clinical attribute index of the target clinical trial project is generated according to the target clinical trial data. The target value provides a standard for the control of clinical trial projects, which is conducive to improving the control efficiency of clinical trial projects.

[0004] However, the data of the above-mentioned patent technology is concentrated in a centralized server, which has the risk of tampering or loss of test data, and cannot guarantee the safety and reliability of the test data. SUMMARY

[0005] 1. The technical problem to be solved by the present application

[0006] The purpose of the present application is to provide a method for establishing a distributed clinical trial system to solve the problems raised in the background art:

[0007] (1) How to use blockchain platforms, smart contracts and other technical means to achieve distributed storage and sharing of test data, improve the transparency, safety and reliability of test data.

[0008] 2. Technical solution

[0009] To achieve the above-mentioned purpose, the present application provides the following technical solution:

[0010] A method for establishing a distributed clinical trial system, setting up a subject record node on the computer or server of each medical department or logistics department in the clinical trial, and using blockchain technology to realize synchronous modification and storage of subject information between each subject record node, comprising the following steps:

[0011] a) Design a distributed ledger system based on blockchain technology, allowing each subject record node to share and update information through the distributed ledger system;

[0012] b) The subject record node determines the content and format of the subject information data that needs to be synchronized and converts it into a form that can be stored by the blockchain;

[0013] c) Design a smart contract that can automatically execute trial rules and processes to ensure the safety and reliability of trial data, define how to verify, add and update data, and how to resolve conflicts and synchronization problems;

[0014] d) Run a subject record node on the computer or server of each medical department or logistics department, which can communicate with other nodes to maintain the distributed ledger system, and each node can store a complete copy of the ledger locally to continue working offline or in the event of network failure;

[0015] e) When new subject information needs to be added or updated, the corresponding subject record node can submit a transaction request for information modification through the smart contract and broadcast the information modification transaction to the entire network, and other subject record nodes can verify the validity of the information modification transaction and record it in their own distributed ledger;

[0016] f) When there is a conflict in updating subject information, the subject record node can use the smart contract to resolve the conflict;

[0017] The subject information includes subject basic information module, subject test information module, subject examination information module, subject medication information module, subject treatment information module, subject follow-up information module, and subject recruitment module.

[0018] The subject basic information module includes a subject basic information unit for collecting and recording a set of data of subject basic information in clinical research; wherein, the information including age, gender, race, education, occupation, marital status, medical history and family history is from the subject recruitment unit.

[0019] The subject test information module includes a subject test information unit for collecting and recording a set of data of subject test results in clinical research.

[0020] The subject examination information module includes a subject examination information unit for collecting and recording data of subject examination results in clinical research;

[0021] The subject medication information module includes a subject medication information unit for recording data of subject medication information recorded in clinical research, which includes information such as the type, dosage, frequency, and duration of medication, and possible side effects of the medication received by the subject. The unit includes information such as the type, dosage, frequency, and duration of medication, and possible side effects of the medication received by the subject;

[0022] The subject treatment information module includes a subject treatment information unit for recording data of subject treatment plans recorded in clinical research;

[0023] The subject follow-up information module includes a subject follow-up information unit for recording data of subject follow-up information recorded in clinical research;

[0024] The subject recruitment module includes a subject recruitment unit for recording data of subject recruitment and screening in clinical research.

[0025] As a preferred method for establishing a distributed clinical trial system, in step a), a distributed ledger system based on blockchain technology is designed using the EOS blockchain platform.

[0026] As a preferred method for establishing a distributed clinical trial system, in step b), the subject record node can convert the data into JSON format and perform hash processing to ensure data integrity and tamper resistance.

[0027] As a preferred method for establishing a distributed clinical trial system, in step c), the first-come-first-served principle can be used, that is, the first submitted data will be considered as the correct version.

[0028] As a preferred method for establishing a distributed clinical trial system, in step f), a majority voting method can be used, that is, the correct version is determined according to the source and history of the data.

[0029] As a preferred method for establishing a distributed clinical trial system, the distributed clinical trial system also develops a front-end application program, which enables users to access clinical trial data and perform various operations. The front-end application program can be developed using Web technology and interacts with the EOS smart contract.

[0030] After adopting such a structure, the method for establishing a distributed clinical trial system uses blockchain technology to realize information synchronization, modification and storage between each subject record node. The distributed clinical trial system has high reliability, security and transparency, can ensure the integrity and consistency of data, and does not need to trust any centralized third-party institution.

[0031] The method for establishing a distributed clinical trial system provides accurate data support for clinical drug analysis, which is an urgent problem for technical personnel in the related field.

[0032] The advantages of the method for establishing a distributed clinical trial system are:

[0033] 1. Higher transparency: the decentralized clinical trial system can realize the openness and transparency of the trial data, and anyone can view the trial results and data sources.

[0034] 2. Faster data acquisition speed: the decentralized clinical trial system can acquire trial data in real time, accelerating the progress and result analysis of the trial.

[0035] 3. Lower cost: compared with traditional centralized clinical trials, the cost of decentralized clinical trials is lower, because a large number of equipment and human resources are not needed to maintain the trial system.

[0036] 4. Higher data security: the decentralized clinical trial system can prevent trial data from being tampered with or lost, ensuring the security and reliability of the trial data. BRIEF DESCRIPTION OF DRAWINGS

[0037] Figure 1 is an information updating mechanism schematic diagram of an embodiment of the method for establishing a distributed clinical trial system.

[0038] Figure 2 is a block diagram of subject information in an embodiment of the method for establishing a distributed clinical trial system. DETAILED DESCRIPTION

[0039] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific embodiments of the present application will be described in detail below. In the following description, a large number of specific details are set forth in order to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the spirit of the present application, therefore the present application is not limited to the specific implementation disclosed below.

[0040] The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are only for illustrative purposes and do not represent the only implementation.

[0041] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0042] The method of establishing a distributed clinical trial system sets up subject record nodes on computers or servers of various medical departments or logistics departments in the clinical trial (various medical departments or logistics departments include outpatient medical record management departments, examination / laboratory departments, outpatient diagnosis departments, prescription management departments, outpatient nurse stations, emergency verification label printing equipment, outpatient skin test departments, outpatient infusion departments, resident physician stations, inpatient nurse stations, etc.), as shown in Figure 1 The use of blockchain technology to achieve synchronization and modification of subject information between various subject record nodes, storage can take the following steps:

[0043] a) Use the EOS blockchain platform to design a distributed ledger system based on blockchain technology, allowing each subject record node to share and update information through the distributed ledger system.

[0044] b) The subject record node determines the subject information data content and format that needs to be synchronized, and converts it into a form that can be stored by the blockchain. The subject record node can convert the data into JSON format and perform hash processing to ensure data integrity and tamper resistance.

[0045] c) Design a smart contract,

[0046] Create a smart contract on the EOS platform to manage the decentralized functions of the clinical trial system. The smart contract is the core part of the decentralized clinical trial system. The smart contract can automatically execute trial rules and processes, ensuring the safety and reliability of trial data, defining how to verify, add and update data, and how to solve conflicts and synchronization problems. The first-come-first-served principle can be used, that is, the first submitted data will be considered as the correct version.

[0047] Use programming languages such as Solidity to write smart contract code. The smart contract should be able to perform various operations, such as adding, deleting and updating clinical trial data, and verifying and authorizing user identities.

[0048] d) In each medical department or logistics department computer or server runs a subject record node, which can communicate with other nodes, maintain a distributed ledger system together, and each node can store a complete copy of the ledger locally, so as to continue to work offline or network failure.

[0049] Deploy the smart contract to the EOS network and ensure that the EOS network is seamlessly integrated with the subject record node and the smart contract.

[0050] e) When there is new subject information to be added or updated, the corresponding subject record node can submit a transaction request for information modification through the smart contract, and broadcast the information modification transaction to the entire network, and other subject record nodes can verify the validity of the information modification transaction and record it in their own distributed ledger.

[0051] f) When there is a conflict in updating the subject information, the subject record node can use the smart contract to resolve the conflict, which can use a majority voting method, that is, according to the source and history of the data to determine the correct version.

[0052] g) The distributed clinical trial system also develops a front-end application, which develops an easy-to-use front-end application for the clinical trial system, and the front-end application enables users to access clinical trial data and perform various operations. The front-end application can be developed using web technologies such as React or Angular, and interacts with the EOS smart contract.

[0053] h) Test the decentralized function of the clinical trial system to ensure that it works as expected. If necessary, optimize and improve the system to improve its performance and reliability.

[0054] Among them, as shown in Figure 2 the subject information includes a subject basic information module, a subject test information module, a subject examination information module, a subject medication information module, a subject treatment information module, a subject follow-up information module, and a subject recruitment module;

[0055] The subject basic information module includes a subject basic information unit for collecting and recording a set of data of subject basic information in clinical research; wherein, the information including age, gender, race, education, occupation, marital status, medical history and family history, etc. comes from the subject recruitment unit;

[0056] The subject test information module includes a subject test information unit for collecting and recording a set of data of subject test results in clinical research;

[0057] The subject examination information module comprises a subject examination information unit for collecting and recording data of subject examination results in clinical research;

[0058] The subject medication information module comprises a subject medication information unit for recording data of subject medication information in clinical research, the subject medication information unit comprising information of subject medication types, dosages, frequencies, medication time lengths, and possible side effects, etc.

[0059] The subject treatment information module comprises a subject treatment information unit for recording data of subject treatment plans in clinical research;

[0060] The subject follow-up information module comprises a subject follow-up information unit for recording data of subject follow-up conditions in clinical research;

[0061] The subject recruitment module comprises a subject recruitment unit for recording data of subject recruitment and screening in clinical research.

[0062] The above is only one embodiment of the present application, and it should be noted that those skilled in the art can make several modifications and improvements without departing from the principles of the present application, which should be considered as falling within the scope of the present application.

Claims

1. A method for establishing a distributed clinical trial system, comprising setting up subject recording nodes on computers or servers in various medical departments or logistics departments during the clinical trial, and utilizing blockchain technology to achieve synchronous modification and storage of subject information among the various subject recording nodes, including the following steps: a) Design a distributed ledger system based on blockchain technology, so that each subject's record node can share and update information through the distributed ledger system; b) The subject recording node determines the content and format of the subject information data that needs to be synchronized and converts it into a form that can be stored on the blockchain; c) Design smart contracts that can automatically execute test rules and processes, ensure the security and reliability of test data, define how to verify, add and update data, and how to resolve conflicts and synchronization issues; d) Run a subject recording node on the computer or server of each medical department or logistics department. The subject recording node can communicate with other nodes to jointly maintain the distributed ledger system. Each node can store a complete copy of the ledger locally so that it can continue to work when offline or in the event of network failure. e) When new subject information needs to be added or updated, the corresponding subject record node can submit a transaction request for information modification through a smart contract and broadcast the information modification transaction to the entire network. Other subject record nodes can verify the validity of the information modification transaction and record it in their own distributed ledger. f) When there is a conflict in updating the subject information, the subject record node can use a smart contract to resolve the conflict; The subject information includes a subject basic information module, a subject test information module, a subject examination information module, a subject medication information module, a subject treatment information module, a subject follow-up information module, and a subject recruitment module; The subject basic information module includes a subject basic information unit, which is a set of data used to collect and record the basic information of subjects in clinical research; among which, information such as age, gender, race, education level, occupation, marital status, medical history and family medical history are obtained from the subject recruitment unit; The subject test information module includes a subject test information unit, which is used to collect and record a set of data on the test results of subjects in clinical studies; The subject examination information module includes a subject examination information unit, which is used to collect and record subject examination results data in clinical studies; The subject medication information module includes a subject medication information unit, which is used to record data on the drug treatment information of subjects in clinical studies. The subject medication information unit includes information such as the type, dosage, frequency and duration of medication received by the subject, as well as possible side effects. The subject treatment information module includes a subject treatment information unit, which is used to record data on the subject treatment plan in clinical research. The subject follow-up information module includes a subject follow-up information unit, which is used to record data on subject follow-up in clinical studies; The subject recruitment module includes a subject recruitment unit for recording data related to subject recruitment and screening in clinical studies.

2. The method for establishing a distributed clinical trial system according to claim 1, characterized in that: In step a), a distributed ledger system based on blockchain technology is designed using the EOS blockchain platform.

3. The method for establishing a distributed clinical trial system according to claim 1, characterized in that: In step b), the subject record node can convert the data into JSON format and hash it to ensure the integrity and immutability of the data.

4. The method for establishing a distributed clinical trial system according to claim 1, characterized in that: In step c), a first-come, first-served principle can be adopted, meaning that the first data submitted will be considered the correct version.

5. The method for establishing a distributed clinical trial system according to claim 1, characterized in that: In step f), a majority vote method can be used, that is, the correct version can be determined based on the source and history of the data.

6. The method for establishing a distributed clinical trial system according to claim 2, characterized in that: The distributed clinical trial system also has a front-end application that enables users to... To access clinical trial data and perform various operations, the front-end application can be developed using web technologies. It also interacts with the smart contracts of the EOS blockchain platform.

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