KR20220060932A - System and method for connecting clinical trial using blockchain network - Google Patents

Abstract

Embodiments are related to a system and method for clinical trial relay. The method comprises the steps of: registering a clinical trial requesting institution, a patient, and a medical institution conducting a clinical trial on a system; retrieving a candidate patient matching a condition of a clinical trial planned by the clinical trial requesting institution; obtaining consent of the candidate patient to share clinical data when the candidate patient is retrieved; supplying clinical data of the patient subject to the clinical trial who has consented to share the clinical data; and recording a supply history in blockchain.

Description

Clinical trial relay system and method using blockchain network {SYSTEM AND METHOD FOR CONNECTING CLINICAL TRIAL USING BLOCKCHAIN NETWORK}

The present invention relates to a technology for relaying clinical trials, and more particularly, to a system and method for relaying clinical trials using a blockchain network.

Clinical trials are an essential process for the development of drugs for the treatment or prevention of diseases. However, clinical trials have a number of difficulties in recruiting patients to confirm the safety and efficacy of the drug. For example, the huge cost of advertising patient recruitment for clinical trials, the need for additional manpower input due to the tendency of hospital-centered clinical trial patient recruitment when the clinical trial is hosted by a non-hospital (eg, a pharmaceutical company); There are difficulties such as the patient's fear of exposing their medical information.

Patent Laid-Open Publication No. 10-2011-0092252

The present invention, in one aspect, does not require a separate clinical trial patient recruitment when subscribing to the system, and uses blockchain technology to relay clinical trials using a blockchain network that guarantees prevention of forgery/falsification of patient's medical information Systems and methods may be provided.

In addition, embodiments of the present invention also provide a computer-readable recording medium in which a computer program is recorded for performing the above-described clinical trial relay method.

Embodiments of the present invention, according to one aspect, the clinical relay method includes: registering a clinical trial requesting institution, a patient, and a medical institution performing a clinical trial on a system; searching for a candidate patient matching the conditions of the clinical trial planned by the clinical trial sponsor; when the candidate patient is found, obtaining consent of the candidate patient for sharing clinical data; supplying clinical data of a clinical trial subject patient who has obtained consent to share the clinical data; And it provides a clinical trial relay method performed by a computing device including a processor, comprising the step of recording the supply history in the block chain.

In one embodiment, the step of registering on the system, generating the private key and public key of the clinical trial sponsor, patient and medical institution; transmitting the private keys of the clinical trial requesting institution, the patient, and the medical institution to the clinical trial requesting institution device, the patient device, and the medical institution device, respectively; It may include obtaining consent from the patient device to share medical information.

In one embodiment, both consent to sharing medical information and consent to sharing clinical data may be required in order to supply the clinical data.

In one embodiment, the method further includes: obtaining consent to share additional clinical data in order to supply additional clinical data of a clinical trial subject patient who has given consent to share medical information and to share clinical data may include

In one embodiment, the step of supplying the clinical data of the candidate patient who has obtained the consent to share the clinical data includes the consent to sharing the clinical data so that the data server stores the consent to sharing the clinical data. transmitting; and receiving and transmitting the clinical data from the data server.

In an embodiment, the searching for candidate patients may include: obtaining the number of candidate patients for each medical institution by searching for candidate patients matching the test conditions; and obtaining approval from the medical institution.

In one embodiment, the test conditions include patient information, medical institution information, diagnosis history information, medication history information, genetic mutation information, genetic test information, test result information, allergy and side effects information, vaccination history information, biosignal information And it may include one or more of legal infectious disease information.

In one embodiment, the genetic mutation information may include the name of the gene in which the mutation has occurred, or the exon ID of the gene in which the mutation has occurred.

In one embodiment, the step of recording the supply history in the block chain includes: generating a supply history transaction based on a hash value of the supply history information and clinical data; and recording the supply history transaction in a blockchain. The supply history information includes at least one of a supply time stamp, a clinical trial requesting institution that has received clinical data, a medical institution that has sent clinical data, approval information, content of consent for sharing clinical data, and test conditions, The hash value of clinical data is a value calculated by applying the clinical data to a hash function.

In one embodiment, the method comprises: receiving a request for verification of forgery of the clinical data; and comparing the hash value of the clinical data recorded in the block chain with the hash value of the supplied clinical data to verify whether or not forgery or not.

A computer-readable recording medium according to another aspect of the present invention may record a computer program for performing the clinical trial relay method according to the above-described embodiments.

A clinical trial relay system according to another aspect of the present invention includes a platform server that communicates with a node that is a participant in a blockchain network; It may include a terminal. The platform server receives registration requests from the clinical trial requesting institution device, the medical institution device, and the patient terminal, and registers the clinical trial requesting institution, the patient, and the medical institution performing the clinical trial on the system, and from the clinical trial requesting institution device Receives the conditions of the clinical trial planned by the clinical trial sponsoring institution, searches for a candidate patient matching the conditions of the clinical trial, and when the candidate patient is found, requests the candidate patient's consent to share clinical data with the patient Transmitting to the terminal to obtain the consent of the candidate patient, supply the clinical data of the clinical trial subject patient who has obtained consent to share the clinical data for the relevant clinical trial, and store the supply history of the clinical data in the block chain can also be recorded.

In one embodiment, the system, the clinical trial relay system may proceed to share the clinical data through a smart contract (smart contract).

A clinical trial requesting institution that has subscribed to the clinical trial relay system according to an aspect of the present invention can search and secure the target patient required for the planned clinical trial from the medical information of the patient who has agreed to share the medical information. .

As a result, the clinical trial sponsor can dramatically reduce the cost of recruiting clinical trial patients.

The clinical trial relay system can manage the patient's clinical data provision history based on shared transactions using blockchain technology.

In addition, in the clinical trial relay system, patients can select some or all of their medical information to be shared in the process of consenting to sharing medical information, and can verify whether the medical information provided to the clinical trial sponsor has been forged or forged. It is possible to minimize the risk of information leakage of patients. In particular, the patient's role as a data subject in the clinical trial process can be strengthened by confirming consent for each clinical trial whether or not to provide clinical trial data to the relevant clinical trial for patients who have agreed to join the system and primary share.

Effects of the present invention are not limited to the effects mentioned above, and other effects not mentioned will be clearly understood by those skilled in the art from the description of the claims.

In order to more clearly explain the technical solutions of the embodiments of the present invention or the prior art, drawings necessary for the description of the embodiments are briefly introduced below. It should be understood that the following drawings are for the purpose of explaining the embodiments of the present specification and not for the purpose of limitation. In addition, some elements to which various modifications such as exaggeration and omission have been applied may be shown in the drawings below for clarity of description.
1 is a schematic configuration diagram of a clinical trial relay system according to an embodiment of the present invention.
2 is a system flow diagram of a process of registering a patient with a medical institution, according to an embodiment of the present invention.
3 is a flowchart of a process of registering a clinical trial sponsoring institution and searching for a clinical trial patient desired by the clinical trial sponsoring institution, according to an embodiment of the present invention.
4 is a flowchart of a clinical data supply process according to an embodiment of the present invention.
5 is a system flow diagram of a clinical data verification process according to an embodiment of the present invention.
6 is a system flow diagram of a process of supplying additional clinical data according to an embodiment of the present invention.
7 is a system flow diagram of a process of supplying additional clinical data according to another embodiment of the present invention.
8 is a flowchart of a clinical trial relay method according to an embodiment of the present invention.

The terminology used herein is for the purpose of referring to specific embodiments only, and is not intended to limit the present invention. As used herein, the singular forms also include the plural forms unless the phrases clearly indicate the opposite. As used herein, the meaning of "comprising" specifies a particular characteristic, region, integer, step, operation, element and/or component, and the presence or absence of another characteristic, region, integer, step, operation, element and/or component It does not exclude additions.

Although not defined otherwise, all terms including technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the present invention belongs. Commonly used terms defined in the dictionary are additionally interpreted as having a meaning consistent with the related technical literature and the presently disclosed content, and unless defined, are not interpreted in an ideal or very formal meaning.

As used herein, a “node” is a participant in a blockchain network and includes various communicationable electronic devices such as servers, personal computers, smart phones, and terminals.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.

1 is a schematic block diagram of a clinical trial relay system 1 according to an embodiment of the present invention.

Referring to FIG. 1 , the clinical trial relay system 1 includes a clinical trial requesting institution device 10 ; medical institution device 20; patient device 30; It may include one or more of the data server 40 and/or the blockchain platform server 50 .

The clinical trial relay system 1 according to the embodiments may have aspects that are entirely hardware, entirely software, or partially hardware and partially software. For example, the clinical trial relay system 1 may collectively refer to hardware equipped with data processing capability and operating software for driving the same. As used herein, terms such as “unit,” “module,” “device,” or “system” are intended to refer to a combination of hardware and software run by the hardware. For example, the hardware may be a data processing device including a central processing unit (CPU), a graphic processing unit (GPU), or another processor. In addition, software may refer to a running process, an object, an executable file, a thread of execution, a program, and the like.

The clinical trial requesting institution device 10 is a device used in the clinical trial requesting institution. The device 10 is an electronic device including a processor such as a computer, and an application for performing data inquiry or request and final data acquisition may be installed.

The clinical trial requesting institution is an institution that plans or designs a clinical trial and requests a clinical trial to a medical institution that conducts the clinical trial, and may be, for example, a contract research organization (CRO) or a pharmaceutical company.

The medical institution device 20 is a device used in a clinical trial performing medical institution to obtain clinical data of a patient by conducting a clinical test on a patient. The device 20 is an electronic device including a processor such as a computer, and an application for performing data inquiry or request, and transmission of final data to another component (eg, the data server 40 ) may be installed.

The final data includes information on target patients required for clinical trials planned or designed by the clinical trial sponsoring institution. The information about the target patient includes, for example, identification information of the target patient and/or clinical data of the target patient. This final data is stored in the data server 40 as off-chain data, described below.

In an embodiment, the medical institution device 20 may generate off-chain data of the target patient that satisfies a medical information standard. For example, the medical institution device 20 may include a Fast Healthcare Interoperability Resources (FHIR) API, and may generate off-chain data according to the FHIR standard through the FHIR API. Then, when the patient's medical data is shared, it is shared in the form of an FHIR resource using the FHIR API.

However, the FHIR standard is merely an example, and it will be apparent to those skilled in the art that the medical institution device 20 may share off-chain resources through other medical information standards.

Patient device 30 is a device used by a patient or caregiver. The patient device 30 may be a communicable electronic device including a processor, including a personal computer, a smart phone, a terminal, and the like. The patient device 30 may install an application that performs data inquiry and request.

The clinical trial requesting institution device 10 , the medical institution device 20 , and the patient terminal 30 communicate with the block chain platform server 50 and function as a node participating in the block chain of the platform service. The clinical trial sponsor device 10 , the medical institution device 20 , and the patient terminal 30 operate as individual entities participating in platform services to provide or receive necessary data, and to verify the integrity of these data with each other.

The data server 40 and the blockchain platform server 50 are a number of computer systems or computer software implemented as network servers. Here, the network server is a computer system and computer that is connected to a subordinate device capable of communicating with another network server through a computer network such as a private intranet or the Internet, receives a request for performing a task, performs the task, and provides an execution result It means software (network server program). However, in addition to such a network server program, it should be understood as a broad concept including a series of application programs operating on the network server and various databases built therein in some cases.

The data server 40 is an off-chain storage that stores off-chain data about patients participating in the clinical trial relay system 1 or a set (ie, database) thereof. Off-chain storage refers to a space that stores data outside of the blockchain. The database refers to a large set of structured, unstructured, or semi-structured data, and may include patient-related data. Here, the structured data is data stored in a fixed field, for example, a relational database, a spreadsheet, or the like. In addition, the unstructured data is data that is not stored in a fixed field, and includes, for example, text documents, images, moving pictures, and voice data. In addition, semi-structured data is not stored in a fixed field, but includes metadata or schema, for example, XML, HTML, text, and the like.

The data server 40 stores off-chain medical information such as patient information indicating identification information of the patient, medical institution information that has treated the patient, diagnosis history, medication history, and the like. The medical information includes information on medical record summary items and/or genetic test information.

In one embodiment, off-chain data stored in data server 40 may include one or more of the details in the following table.

Classification Details explanation patient information Patient ID Patient ID generated by the medical institution birth date Patient's date of birth (YYYYMMDD) patient gender Patient gender statement patient name contact Patient contact information address patient address Medical institution information Medical institution identification number A number assigned to identify a medical institution Nursing home symbol Health Insurance Review and Assessment Service Nursing Institution Symbol name of nursing institution name of nursing institution Nursing Institution Contact Nursing institution phone number Nursing home address Nursing home address Diagnosis history Diagnosis date Diagnosis date of the relevant disease Sang Byeong-myung Corporal Code Name (KCD 7) corporal code Corporal Code (KCD 7) dosing history Prescription date Prescription date and time of the prescribed drug Prescription drug name KD code name of prescribed drug prescription drug code KD code of prescription drug Main ingredient name ATC Active Ingredient Code Names for Prescribed Drugs main component code ATC Active Ingredient Codes for Prescribed Drugs Volume Total daily dose of prescribed medications dosage unit Total daily dosage unit of prescribed drug dosing period Total number of days of medication prescribed usage Prescription drug usage information genetic mutation gene name of the gene in which the mutation occurred Exon ID Exon ID of the mutated gene genetic testing information Request request date Date of request for genetic testing Target sample type Sample types for genetic testing Inspection result details test result text test results Inspection date and time Date and time of the inspection Inspection item name Item name of the inspection Prosecutor's name Applicable inspection name inspection code code of the check Test result value the result of the test reference value Reference value for the test result surgery history date of surgery date of surgery operation name operation name operation code operation code Diagnosis after surgery Diagnosis after surgery Allergies and side effects registration date Registration date by allergy Allergy factors Allergy Factor Name Allergy name Allergy name reaction allergic reaction Vaccination history inoculation date Date of vaccination Vaccination name Vaccination name immunization code immunization code biosignals and status measurement date Date of measurement of the corresponding biological signal key measured height weight measured weight blood pressure (systolic) Measured systolic blood pressure blood pressure (diastolic) Measured diastolic blood pressure temperature measured body temperature legal contagious disease onset date Date of Onset of Legal Infectious Disease Report Diagnosis date Diagnosis date of the notification of statutory infectious disease Infectious disease name Infectious disease name in the legal infectious disease report report date Report date of statutory infectious disease notification patient classification Patient Classification of Legal Infectious Disease Report Confirmation test result Confirmation test result of legal infectious disease report Hospitalization Whether or not to be hospitalized in the report of a legal contagious infectious disease Presumptive infection area Estimated area of infection in the notification of statutory infectious disease

In an embodiment, the data server 40 is a simple storage service (S3) provided by Amazon.Com, Inc., and a Google file system (GFS) provided by Google (Google Inc.). ; Google File System), or Microsoft Office Online provided by Microsoft Corporation), refers to a clouding database computing resource in which applications and data are stored on a remote server.

The blockchain platform server 50 is a component that relays the interaction between the clinical trial requesting institution 10, the medical institution device 20, the patient device 30, and the data server 40, and a server unit that operates the platform service may be referred to as

When receiving a specific request from the clinical trial requesting institution 10 or the patient device 30, the blockchain platform server 50 may perform an operation corresponding to the request to provide a result for the request.

In addition, the block chain platform server 50 may perform an operation of recording the history of relaying clinical trials in the block chain.

Here, the blockchain network is a network composed of nodes that want to use the blockchain as a distributed ledger. The distributed ledger distributes the ledger recording transaction information in a peer-to-peer network rather than a central server of a specific institution, and is recorded and managed jointly by members. Each member (i.e., node) of a blockchain network uses a consensus protocol to agree on the contents of the ledger (commonly referred to as a transaction). The blockchain network records the transactions agreed on by all nodes in chronological order, and once stored in the blockchain, the transaction records cannot be changed. In addition, the blockchain network uses a digital signature based on the PKI algorithm to ensure the integrity of the transaction.

The block chain represents a data structure in which a plurality of transactions are grouped every predetermined time to generate one block, and the block is continuously connected to an existing block like a chain. Various pieces of information may be included in the blocks.

In some embodiments, the blocks may include a block hash value of a corresponding block, a nonce value, a block hash value of a previous block, and the like. The block hash value and the nonce value are values obtained using a preset hash function. In addition, the blocks may include information on software executing the system 1, block creation time, information related to nodes (eg, IP address of the blockchain platform server 50, etc.).

These blockchains are stored in individual blockchain distributed storage of each node participating in the blockchain network. The blockchain distributed storage of each node is a predetermined storage space inside the node for distributed storage of the blockchain results generated by the blockchain network to each node. It refers to the storage component that constitutes the entire distributed storage of the blockchain network. . Data stored in the blockchain is propagated to other nodes through the blockchain network, and the result of data propagation is again stored in the other nodes. As a result of propagation to all nodes, the blockchain copy data (or file) stored in the blockchain distributed storage of each node is substantially the same as the data recorded on the blockchain, and is sufficient to verify the validity of the propagated data.

In this specification, unless otherwise specified, it is described that data stored in the blockchain of the blockchain network is stored in the blockchain distributed storage of the node.

In one embodiment, the clinical trial relay system 1 may be a private blockchain system based on Hyperledger Fabric, and the blockchain platform server 50 issues a membership service provider (MSP) that manages authentication in the network. As an institution and management, it may be a Certificate Authority (CA). In Hyperledger Fabric, the CA first checks the participant's signature and authorization, and checks whether the predefined endorsement policy is complied with before being recorded in the ledger through the node. The guarantee policy has the content that the transaction must be authorized by the specified node. For example, a transaction for information sharing in the clinical trial relay system 1 requires permission of a designated patient terminal.

In an embodiment, the on-chain data stored in the blockchain may include one or more of the detailed items in Table 2 below.

Classification Details explanation patient information Patient ID Patient ID generated by the medical institution birth date Patient's date of birth (YYYYMMDD) patient gender Patient gender Medical institution information Medical institution identification number A number assigned to identify a medical institution Nursing home symbol Health Insurance Review and Assessment Service Nursing Institution Symbol name of nursing institution name of nursing institution Diagnosis history Diagnosis date Diagnosis date of the relevant disease Sang Byeong-myung Corporal Code Name (KCD 7) corporal code Corporal Code (KCD 7) dosing history Prescription date Prescription date and time of the prescribed drug Prescription drug name KD code name of prescribed drug prescription drug code KD code of prescription drug Main ingredient name ATC Active Ingredient Code Names for Prescribed Drugs main component code ATC Active Ingredient Codes for Prescribed Drugs Volume Total daily dose of prescribed medications dosage unit Total daily dosage unit of prescribed drug genetic mutation gene name of the gene in which the mutation occurred Exon ID Exon ID of the mutated gene

The blockchain platform server 50 records this on-chain data on the blockchain network.

The blockchain platform server 50 retrieves clinical data from the off-chain data of Table 1 and supplies it to the device 10 of the clinical trial requesting institution, or stores the on-chain data of Table 2 in the blockchain network as a result of the supply. may be The operation of the system 1 will be described in more detail with reference to FIGS. 2 to 7 below.

2 is a system flow diagram of a process of registering a patient with a medical institution, according to an embodiment of the present invention.

Referring to FIG. 2 , the medical institution device 20 transmits a registration request to the blockchain platform server 50 ( S211 ). The registration request includes identification information of a medical institution, a communication address (eg, an IP address), and the like.

When the block chain platform server 50 receives the registration request of the medical institution device 20, it registers the medical institution as a system subscriber (S212).

In addition, the blockchain platform server 50 allocates a security key to the medical institution (S214). In one embodiment, the security key assigned to the medical institution device includes a private key and a public key. In step S214, the private key and the public key are mapped to the registration information of the medical institution.

The blockchain platform server 50 transmits a system registration notification to the medical institution device 20 (S215). In one embodiment, the system registration notification includes a private key assigned to the corresponding medical institution. The medical institution device 20 may digitally sign data using the received private key of the medical institution and transmit the digitally signed data to the blockchain platform server 50 .

The patient device 30 also transmits a registration request for registration as a system subscriber to the blockchain platform server 50 (S221). Then, similar to the registration process of the medical institution device 20 , a private key and a public key of the patient device 30 are allocated, and the patient's private key is provided to the patient device 30 ( S222 to S225 ). The patient device 30 may digitally sign data using the received patient's private key and transmit the digitally signed data to the blockchain platform server 50 .

The clinical trial relay system 1 may proceed to share medical information through a smart contract. A smart contract is a script that causes the contract to be executed when certain conditions are met. The patient's consent to share the clinical trial may be specified as a condition for the implementation of the medical information sharing operation. The above conditions may be subdivided or variously modified and applied according to the subject of consent.

The clinical trial relay system 1 may supply clinical data of a patient who has consented to sharing their own medical information to other system subscribers (eg, the clinical trial sponsoring institution device 10 ). To this end, the clinical trial relay system 1 is configured to obtain consent for sharing medical information by the patient device 30 (S230). The consent to share medical information indicates that the patient intends to share his/her own medical information for the clinical trial while joining the clinical trial relay system 1 as a system participant. However, the consent to share medical information does not mean that the person intends to share clinical data for clinical trials immediately. A patient who has written consent for sharing medical information shares clinical data only for a specific clinical trial that he/she wants to participate in among various clinical trials relayed through the clinical trial relay system 1. In one embodiment, the step S230 includes It includes the step (S231) of generating a medical information sharing agreement and transmitting it to the blockchain platform server 50.

The patient device 30 is configured to generate a medical information sharing agreement in response to receiving the system registration notification (S231). In the step S231, the patient device 30 provides the patient with a screen for writing a medical information sharing agreement. Then, the patient device 30 receives the patient input for writing the medical information sharing agreement, generates the medical information sharing agreement, and transmits it to the blockchain platform server 50 (S231).

In one embodiment, the medical information sharing agreement may include the identification information of the patient, the patient's medical institution, clinical trial information, and/or the scope of sharing medical information. The patient's medical institution may include a medical institution of the medical institution device 20 .

The medical information sharing range is set as some or all of the medical information in Table 1 above. The clinical trial relay system 1 may set the sharing range of medical information by allowing the patient device 30 to select some or all of the classification items of the medical information in Table 1. In addition, the clinical trial relay system 1 may set the sharing range of medical information by selecting some or all detailed items of the medical information in Table 1. For example, when only diagnosis and medication classification are selected in Table 1, sharing of clinical data of the patient may be shared only within the scope of diagnosis and medication information.

In an embodiment, the patient device 30 may electronically sign the medical information sharing agreement with the patient's private key (S321). The patient device 30 may transmit the medical information sharing agreement digitally signed by the private key to the blockchain platform server 50 . For example, the patient device 30 may transmit a medical information sharing agreement electronically signed with the patient's private key to the blockchain platform server 50 .

Upon receiving the medical information sharing agreement from the patient device 30 (S231), the blockchain platform server 50 checks the medical institution of the patient who has agreed to share the medical information in the medical information sharing agreement (S234).

In one embodiment, the blockchain platform server 50, upon receiving the electronically signed medical information sharing agreement (S231), verifies the validity of the electronic signature in the electronically signed medical information sharing agreement (S234). Since the blockchain platform server 50 has the patient's public key, it verifies the digital signature using the patient's public key to verify whether the digital signature is genuinely signed by the patient device 30 .

The clinical trial relay system 1 is configured to prepare for sharing the medical information of the patient who has consented to the sharing of the medical information to the system subscribers.

The blockchain platform server 50 is a medical institution of a patient who has agreed to share medical information, and instructs preparation for sharing the patient's medical information to system subscribers (S235). In an embodiment, the instruction of preparation for sharing may be an instruction to cause the medical institution device 20 to configure the consented patient's medical information set and store the configured patient's medical information set in the data server 40 . The instruction of preparation for sharing may include a consent form for sharing medical information.

In one embodiment, the composition of the patient's medical information set depends on the scope of sharing. The instruction of step S235 may include a sharing range of medical information, and then, the medical institution device 20 selects the patient's medical information as an item within the sharing range among the patient's medical information acquired before receiving the instruction in step S235. You can also make sets.

Upon receiving the preparation instruction for sharing with system subscribers, the medical institution device 20 configures the patient's medical information set (S236). In one embodiment, the medical information set includes some or all of the off-chain data of Table 1. The medical institution device 20 transmits the patient's medical information set who has agreed to share to the data server 40 through the blockchain platform server 50 . The clinical trial relay system 1 stores the medical information set of the patient who has agreed to share in advance in the data server 40 (S237).

In step S237 , clinical data such as diagnosis, medication, examination, and biosignal required to search for a clinical test target patient are stored in the data server 40 . In addition, the content of the patient's consent to share medical information is also stored in the data server (40).

The clinical trial relay system 1 may supply clinical data including some or all of the patient's medical information set previously stored in the data server 40 upon a request from the clinical trial sponsor.

3 is a flowchart of a process of registering a clinical trial sponsoring institution and searching for a clinical trial patient desired by the clinical trial sponsoring institution, according to an embodiment of the present invention.

Referring to FIG. 3 , the clinical trial requesting institution device 10 also transmits a registration request for registration as a system subscriber to the blockchain platform server 50 ( S311 ). Then, similarly to the registration process of the medical institution device 20 , the private key and public key of the clinical trial requesting institution are allocated, and the private key of the clinical trial requesting institution is provided to the clinical trial requesting institution device 10 ( S312 to S315).

The registered clinical trial sponsor may search whether a patient matching the desired test condition is a system subscriber (S320). In the step S320, the clinical trial requesting institution device 10 transmits a search request including the desired test condition to the blockchain platform server 50 (S321). The blockchain platform server 50 generates a search instruction based on the test conditions included in the search request (S322). The search instruction includes a test condition.

In an embodiment, the test condition may be metadata of information stored in the data server 40 . In the clinical trial relay system 1, some or all of the items expected to have a high search frequency in the clinical trial sponsoring institution in off-chain data may be defined as metadata. The metadata may include, for example, one or more of a diagnosis history, a medication history, and a genetic mutation in the classification of Table 2.

The data server 40 searches for a candidate patient matching the test condition from among the registered patients in which the medical information set is configured (S324). When a candidate patient is searched, the data server 40 generates the number of candidate patients for each medical institution as search result data (S324).

The clinical trial relay system 1 transmits the number of candidate patients for each medical institution from the data server 40 to the clinical trial requesting institution device 10 through the blockchain platform server 50 (S325).

In one embodiment, the step (S320) may further include the step (S326) of generating the approval and plan of the clinical trial performing institution. In certain embodiments, the approval of the clinical trial conducting institution may be performed only for a medical institution with a relatively large number of candidate patients.

When the device 10 of the clinical trial sponsoring institution acquires the existence of a candidate patient matching the test conditions (S325), the clinical trial sponsoring institution must obtain approval from the medical institution related to the candidate patient to secure the candidate patient as a clinical trial patient. can The approval of the medical institution includes the approval of the bioresearch ethics committee of the medical institution. The approval may be prepared by electrical communication between the clinical trial sponsor device 10 and the medical institution device 20 .

The clinical trial requesting institution approved by the medical institution transmits the approval and the plan to the blockchain platform server 50 through the clinical trial requesting institution device 10 (S327). Then, the blockchain platform server 50 may supply the clinical data of the candidate patient to the clinical trial requesting institution device 10 by confirming the approval and the plan.

In another embodiment, the patient device 30 may transmit a registration request including a medical information sharing agreement to the blockchain platform server 50 . Then, the blockchain platform server 50 may check the patient's medical institution while registering the patient's security key (224) (S234). Subsequently, the clinical data of the candidate patient may be supplied to the device 10 of the clinical trial sponsoring institution by confirming the approval and the plan from the confirmed patient's medical institution.

4 is a flowchart of a clinical data supply process according to an embodiment of the present invention.

Referring to FIG. 4 , the blockchain platform server 50 requests identification information of a candidate patient of an approved medical institution (S410). The step (S410) includes a step (S413) of the block chain platform server 50 searching for the identification information of the candidate patient in the data server 40 (S413).

The blockchain platform server 50 is configured to obtain consent to share clinical data with a clinical trial requesting institution to a clinical trial patient (S420).

In one embodiment, the step (S420) may include the step (S421) of transmitting a request for consent for sharing clinical data to the patient device 30 by the blockchain platform server 50 . The consent request is transmitted based on the identification information of the candidate patient (S421). The above consent indicates that the candidate patient consents to share his/her clinical data with the clinical trial sponsor. If the request for consent to share clinical data is the first after the clinical trial has been approved, it includes the nature of consent to participate in the approved clinical trial. That is, consent to share clinical data has the nature of whether to provide patient information to allow participation in clinical trials and use in clinical trials.

When the candidate patient participates in the clinical trial, the patient device 30 generates a clinical data sharing agreement (S422) and transmits the clinical data sharing agreement to the blockchain platform server 50 (S423). The clinical data sharing agreement may be generated in the form of a snapshot.

The consent to share clinical data in step S420 is different from the consent to share medical information in step S230. The consent of step S420 indicates the intention to actually supply clinical data. Candidate patients who have given consent to share clinical data are determined as clinical trial subjects. As such, the clinical trial relay system 1 strengthens the role of the patient as a data subject through the patient consent process of this two-step process.

When the blockchain platform server 50 receives the clinical data sharing agreement, the blockchain platform server 50 confirms the clinical data sharing agreement (S430). The blockchain platform server 50 treats the candidate patient who has written the consent form in step S420 as a clinical trial target patient. And the data server 40 is instructed to prepare for supplying clinical data of the clinical trial target patient, so that the clinical data is supplied from the data server 40 to the clinical trial requesting institution device 10 (S430).

In one embodiment, the step (S430) includes a step (S431) of transmitting the clinical data supply preparation instruction (hereinafter, “preparation instruction”) of the clinical trial subject patient to the data server 40 . The preparation instructions include consent to share clinical data. The data server 40 confirms the consent of the clinical trial subject patient.

The data server 40 prepares to supply clinical data in response to receiving a request for supplying clinical data (S434). The data server 40 prepares to supply clinical data by storing the consent for sharing clinical data (S434). The data server 40 additionally stores the clinical data sharing agreement in the medical information set of the clinical trial subject patient (S434).

In one embodiment, the data server 40 may change the storage state of the clinical trial target patient to the ready state. Clinical data is provided only for clinical trial subjects having the above readiness status.

The data server 40 may transmit the supply ready status to the blockchain platform server 50 . In one embodiment, the clinical trial relay system 1 may transmit a notification of completion of supply preparation from the data server 40 to the clinical trial requesting institution device 10 through the block chain platform server 50 (S435).

Upon receiving the notification of completion of supply preparation, the clinical trial requesting institution device 10 transmits a clinical data supply request to the data server 40 through the block chain platform server 50 (S437). The clinical data supply request may include items of clinical data desired by the clinical trial sponsor. For example, the clinical data supply request includes a clinical data item desired by the clinical trial sponsor.

The data server 40 supplies the requested clinical data to the clinical trial requesting institution device 10 through the blockchain platform server 50 in response to the clinical data supply request (S439).

The supplied clinical data may be detailed information about the clinical trial. In an embodiment, the clinical data may include one or more of the name of the clinical trial, the clinical trial subject, the clinical trial start and end dates, and a physical examination schedule for conducting the clinical trial, and a drug administration schedule.

The clinical trial relay system 1 stores the supply history of clinical data of the clinical trial target patient in the blockchain network (S450).

In one embodiment, the step (S450) may include: generating a hash value of supply history information and clinical data by the data server 40 and transmitting it to the block chain platform server 50 (S451) . The supply history information may include one or more of a supply time stamp, a clinical trial requesting institution that has received clinical data, a medical institution that has sent clinical data, approval information, consent to sharing clinical data, and test conditions. . The consent may be included in the form of a snapshot.

The data server 40 may calculate a hash value of the clinical data by applying the clinical data to the hash function.

The blockchain platform server 50 generates a supply history transaction based on the hash value of supply history information and clinical data (S453). The block chain platform server 50 records the supply history transaction in the block chain and updates the block chain (S453).

In addition, the block chain platform server 50 may pay compensation to the clinical trial subject who participated in the clinical trial when the clinical trial is finished.

The clinical trial relay system 1 can manage the clinical data supply history through transaction management based on blockchain technology. Because the supply history facts recorded in the blockchain are verified through the integrity verification of the blockchain, disputes over the supply history facts are prevented.

The clinical trial relay system 1 may provide a confirmation result when a clinical trial patient requests confirmation that his/her clinical data used in the clinical trial has been used without forgery/falsification.

5 is a system flow diagram of a clinical data verification process according to an embodiment of the present invention.

Referring to FIG. 5 , the patient device 30 transmits a forgery verification request to the blockchain platform server 50 ( S511 ). The forgery verification request may include patient information of the patient device 30 . In an embodiment, the forgery verification request may include clinical trial information in which clinical data is used.

The clinical trial relay system 1 verifies forgery of shared clinical data by comparing the hash value of the clinical data recorded in the block chain with the hash value of the clinical data used by the clinical trial performing institution. Since the clinical data used by the clinical trial performing institution is stored in the data server 40, the blockchain platform server 50 retrieves and acquires the supplied clinical data from the data server 40 (S513 and S515).

The blockchain platform server 50 calculates the hash value of clinical data using the hash value of clinical data found after the verification request. The blockchain platform server 50 compares the hash value of the clinical data recorded in the block chain with the hash value of the clinical data used (S516). If there is a change such as correction/addition to the clinical data used, the hash value of the clinical data recorded in the block chain and the hash value of the clinical data used are different. If the hash values match, it means that there is no change in the clinical data used.

The blockchain platform server 50 may compare the hash values and, if the hash values match, transmit a verification confirmation message indicating that there is no forgery to the patient device 30 . The blockchain platform server 50 may compare the hash values and, if the hash values do not match, transmit a notification that forgery or falsification to the patient device 30 .

The clinical trial relay system 1 may supply additional clinical data even when a clinical trial sponsor who has used clinical data for a clinical trial requests the provision of additional clinical data for a clinical trial patient who has already supplied clinical data.

6 is a system flow diagram of a process of supplying additional clinical data according to an embodiment of the present invention.

Referring to FIG. 6 , when the clinical trial requesting institution desires additional clinical data of a patient subject to a clinical trial, it requests the sharing of additional clinical data to the blockchain platform server 50 ( S610 ). Upon receiving the request to share additional clinical data, the blockchain platform server 50 is configured to obtain consent for sharing additional clinical data with the clinical trial sponsor to the clinical trial subject patient (S620). The consent of the step (S620) is performed even when the clinical trial patient has already participated in the same clinical trial and supplied clinical data.

In an embodiment, the step (S5620) may include a step (S621) of transmitting a consent request for additional clinical data sharing to the patient device 30 by the block chain platform server 50 . The patient device 30 generates a consent form for sharing additional clinical data (S623), and transmits a consent form for sharing additional clinical data to the blockchain platform server 50 (S623).

When the block chain platform server 50 receives the consent form for sharing additional clinical data, the block chain platform server 50 confirms the consent of the clinical trial target patient to share additional clinical data (S630). And it instructs the data server 40 to prepare for supplying additional clinical data of the clinical trial target patient (S630). When the data server 40 is ready to supply the additional clinical data, the additional clinical data is supplied to the clinical trial sponsoring institution device 10 (S630).

In one embodiment, the step (S630) includes the step (S631) of the block chain platform server 50 transmitting a preparation instruction (or “additional preparation instruction”) for supplying additional clinical data to the medical institution device 20 do. The additional preparation instructions include consent to share additional clinical data. The medical institution device 20 confirms the consent of the clinical trial subject patient through the consent form for additional clinical data sharing. In certain embodiments, the consent may be in the form of a snapshot, but is not limited thereto.

In a medical institution, an additional clinical test is performed on a clinical trial target patient, and the medical institution device 20 acquires additional clinical data (S632). Then, the medical institution device 20 transmits the additional clinical data to the data server 40 (S633). In addition, the medical institution device 20 transmits the agreement (eg, a snapshot) for sharing the additional clinical data to the data server 40 (S633).

The data server 40 prepares to supply additional clinical data in response to receiving a request for supplying additional clinical data (S634). The data server 40 prepares to supply additional clinical data by storing the additional clinical data and the consent form for sharing the additional clinical data (S634).

In one embodiment, when the data server 40 receives the additional clinical data, it may change the storage state to the additional supply ready state (S634). The data server 40 may supply additional clinical data to the clinical trial requesting institution 10 when it has a state of complete preparation for additional supply.

The data server 40 may transmit an additional supply ready state to the blockchain platform server 50 . In an embodiment, the clinical trial relay system 1 may transmit a notification of preparation for additional supply from the data server 40 to the clinical trial requesting institution device 10 through the blockchain platform server 50 (S635).

Upon receiving the notification of additional supply preparation, the clinical trial requesting institution device 10 transmits an additional clinical data supply request to the data server 40 through the block chain platform server 50 (S637). The data server 40 supplies the requested additional clinical data to the clinical trial requesting institution device 10 through the blockchain platform server 50 in response to the additional data supply request (S639).

The clinical trial relay system (1) stores the supply history of additional clinical data of clinical trial subjects in the blockchain network (S650)>

In one embodiment, the step (S650) may include a step (S451) of generating a hash value of additional supply history information and additional clinical data by the data server 40 and transmitting it to the block chain platform server 50 there is. The additional supply history information has the same configuration as the supply history information described above in step S450.

The data server 40 may calculate a hash value of additional clinical data by applying the additional supply history information to a hash function.

The blockchain platform server 50 generates an additional supply history transaction based on the hash value of the additional supply history information and additional clinical data (S653). The block chain platform server 50 records the additional supply history transaction in the block chain to update the block chain (S653).

In the clinical trial relay system 1 , before the clinical trial sponsor requests the provision of additional clinical data, the data server 40 may be provided with additional clinical data in advance. In this case, the clinical trial relay system 1 may supply additional clinical data.

7 is a system flow diagram of a process of supplying additional clinical data according to another embodiment of the present invention.

Since the embodiment of FIG. 7 is similar to the embodiment of FIG. 6 , differences will be mainly described.

7 , before the clinical trial sponsor requests the provision of additional clinical data, the data server 40 may store additional clinical data in advance. In addition, the blockchain platform server 50 may receive a request for sharing and supply of additional clinical data (S610).

In this case, when the consent for sharing additional clinical data is received from the patient device 30 (S620), and the preparation for supplying additional clinical data is completed (S631 to S635), the blockchain platform server 50 is the data server 40 to transmit an additional clinical data supply request (S637). Then, the data server 40 transmits the requested additional clinical data to the clinical trial requesting institution device 10 through the blockchain platform server 50 (S639).

Clinical trial relay services of various scenarios can be provided to system participants through the clinical trial relay system 1 .

In one example, assuming that a clinical trial for lung cancer patients is conducted through a clinical trial relay method, in the above example, the clinical trial sponsor is a pharmaceutical company, CRO, etc., using blockchain-based patient search and data sharing. It is a situation registered for the purpose (S311 to S314), and the patient agrees to information sharing and genomic test items for participation in a blockchain-based clinical trial (S221 to S327).

The blockchain platform server 50 may search for non-small cell lung cancer patients and candidate patients with EGFR mutation information based on the metadata. In addition, the number of patients for each medical institution may be obtained (S321 to S325).

The pharmaceutical company creates the approval and plan of the clinical trial candidate patient and submits it to the blockchain platform server 50 (S326 and S327).

The blockchain platform server 50 confirms consent to share clinical data with the candidate patient (S420). When the patient has given consent, if clinical data including genetic test information is stored in the data server 40 , the data server 40 stores the contents of consent (eg, a snapshot) and conducts clinical trials through the blockchain platform server 50 Data is supplied (S430). The clinical data includes lung cancer diagnosis information including non-small cell lung cancer, and genetic test information including gene EGRF mutation information.

If there is no genetic test information in the data server 40, clinical data may be supplied to the patient according to the genetic test result. Since the test conditions include genetic EGRF mutation information, clinical data is provided if the patient has EGRF mutation.

In another example, assuming a clinical trial to compare weight loss according to obesity genes (FTO, MC4R, BDNF) among hypertensive patients over 30 years of age, in the above example, the clinical trial sponsor is a pharmaceutical company based on blockchain It is a situation in which it is registered for patient search and data sharing (S311 to S314), and the patient agrees to information sharing and genomic test items for participation in a blockchain-based clinical trial (S221 to S327).

The blockchain platform server 50 can search for candidate patients with obesity genes (FTO, MC4R, BDNF) among hypertensive patients over the age of 30 based on metadata. In addition, the number of patients for each medical institution may be obtained (S321 to S325).

Pharmaceutical companies, CROs, etc. generate approval and plan for clinical trial candidates and submit them to the blockchain platform server 50 (S326 and S327).

The blockchain platform server 50 confirms consent to share clinical data with the candidate patient (S420). When the patient has given consent, if clinical data including genetic test information is stored in the data server 40 , the data server 40 stores the contents of consent (eg, a snapshot) and conducts clinical trials through the blockchain platform server 50 Data is supplied (S430). The clinical data includes genetic test information including age information 30 years or older, hypertension diagnosis information, and obesity genes (FTO, MC4R, BDNF).

Then, the clinical trial sponsor may conduct a clinical trial by using a patient with an obesity gene as an experimental group and a patient without an obesity gene as a control, based on whether or not there is an obesity gene through genetic testing.

In addition, the clinical trial relay system 1 records supply history information including supply time stamps, snapshots, etc. and hash values of clinical data in the blockchain and stores them in the blockchain network (S450).

In addition, the clinical trial relay system 1 may check forgery by comparing the hash value recorded in the block chain with the hash value of the clinical data used.

In another example, assuming a clinical trial to evaluate the immunogenicity and safety of an influenza vaccine (new drug) in healthy adults aged 18 years or older to 65 years old or younger, in another example, clinical The test requesting institution is a pharmaceutical company, CRO, etc., which is registered for blockchain-based patient search and data sharing (S311 to S314), and the patient agrees to information sharing and blood test items for blockchain-based clinical trial participation is (S221 to S327).

The blockchain platform server 50 may search for a candidate patient aged 18 or older to 65 or younger based on the metadata. In addition, the number of patients for each medical institution may be obtained (S321 to S325).

Pharmaceutical companies, CROs, etc. generate approval and plan for clinical trial candidates and submit them to the blockchain platform server 50 (S326 and S327).

The blockchain platform server 50 confirms consent to share clinical data with the candidate patient (S420). The consent to share clinical data may be stored in the data server 40 as snapshot data.

In order to perform a clinical test, a patient visits a medical institution, receives a test drug and a reference drug at random, and receives a blood test, so that the medical institution device 20 acquires the patient's blood test information.

Thereafter, in order to compare the patient's blood test result data, the clinical trial requesting institution device 10 transmits a clinical data supply request to the block chain platform server 50 (S437). Then, the requested clinical data is supplied from the data server 40 to the clinical trial requesting institution device 10 through the blockchain platform server 50 . The clinical data includes blood test information of the patient.

In addition, the clinical trial relay system 1 records supply history information including supply time stamps, snapshots, etc. and hash values of clinical data in the blockchain and stores them in the blockchain network (S450).

In addition, the clinical trial relay system 1 may check forgery by comparing the hash value recorded in the block chain with the hash value of the clinical data used.

Each of the components 10, 20, 30, 40, and 50 constituting the clinical trial relay system 1 according to the embodiments is not necessarily intended to refer to a physically distinct separate component. Each of the components 10 , 20 , 30 , 40 , and 50 is only functionally classified according to an operation performed by the computing device in which they are implemented, and does not necessarily mean separate elements separated from each other. Although the medical institution device 20 and the data server 40 are shown as separate blocks in FIG. 1 , in certain embodiments, they may be integrated into the same single device.

It will be apparent to a person skilled in the art that the system 1 may include other components not described herein. For example, components 10, 20, 30, 40, and/or 50 of the system 1 may include a network interface, an input device for data entry, and an output device for display, printing, or other data presentation. It may include other hardware elements necessary for the operation described herein, including but not limited to.

The method of relaying a clinical trial according to another aspect of the present invention may be performed by a computing device including a processor (eg, the clinical trial relay system 1 of FIG. 1 ). Hereinafter, for clarity of explanation, the present invention will be described in more detail based on embodiments performed by the clinical trial relay system 1 of FIG. 1 .

8 is a flowchart of a clinical trial relay method according to an embodiment of the present invention.

Referring to FIG. 8 , the clinical trial relay method includes receiving test conditions from the device 10 of the clinical trial sponsoring institution and searching for candidate patients for the clinical trial matching the test conditions ( S810 ).

When the block chain platform server 50 receives a search request including a test condition from the clinical trial requesting institution device 10, it searches for a candidate patient in the data server 40 based on the test condition (S810). In the step (S810), the number of candidate patients for each medical institution is obtained.

In certain embodiments, the clinical trial relay method includes registering a clinical trial sponsor, a patient, and a medical institution as participants in the system before step S810. The registration step includes generating a private key and a public key of a clinical trial requesting institution, a patient, and a medical institution; and transmitting the private keys of the clinical trial requesting institution, the patient, and the medical institution to the clinical trial requesting institution device, the patient device, and the medical institution device, respectively. Since the registration process has been described with reference to FIGS. 2 and 3 , a detailed description thereof will be omitted.

Further, the clinical trial relay method includes receiving a clinical data sharing request (S820) and obtaining patient consent (S830).

In one embodiment, when the request for sharing is the first for a corresponding clinical trial, the patient's consent includes consent to share clinical data with a clinical trial sponsor and a willingness to participate in the clinical trial. As this has been described above with reference to step S420, a detailed description thereof will be omitted.

The clinical trial relay method includes a step of instructing the preparation of clinical data, transmitting the patient's consent (S840). In the step (S840), the blockchain platform server 50 transmits the patient's consent to the data server 40 so that the data server 40 stores the patient's consent. The patient's consent may be transmitted in the form of a snapshot.

The clinical trial relay method includes receiving clinical data from the data server 40 and transmitting the clinical data to the clinical trial requesting institution device 10 ( S850 ). In addition, the clinical trial relay method includes receiving supply history information and a hash value of clinical data from the data server 40 to update the block chain (S860). Steps (S840 to S860) are similar to steps (S430 to S450), so a detailed description will be omitted.

The operations of the systems and methods according to the embodiments described above may be at least partially implemented as a computer program and recorded in a computer-readable recording medium. For example, embodied with a program product consisting of a computer-readable medium containing program code, which may be executed by a processor for performing any or all steps, operations, or processes described.

The computer-readable recording medium includes all types of recording identification devices in which computer-readable data is stored. Examples of the computer-readable recording medium include ROM, RAM, CD-ROM, magnetic tape, floppy disk, optical data storage identification device, and the like. In addition, the computer-readable recording medium may be distributed in a network-connected computer system, and the computer-readable code may be stored and executed in a distributed manner. In addition, functional programs, codes, and code segments for implementing the present embodiment may be easily understood by those skilled in the art to which the present embodiment belongs.

Although the present invention as described above has been described with reference to the embodiments shown in the drawings, it will be understood that these are merely exemplary and that various modifications and variations of the embodiments are possible therefrom by those of ordinary skill in the art. However, such modifications should be considered to be within the technical protection scope of the present invention. Accordingly, the true technical protection scope of the present invention should be determined by the technical spirit of the appended claims.

Claims (13)

In the clinical trial relay method performed by a computing device including a processor,
registering a clinical trial requesting institution, a patient, and a medical institution performing a clinical trial on the system;
searching for a candidate patient matching the conditions of the clinical trial planned by the clinical trial sponsor;
when the candidate patient is found, obtaining consent of the candidate patient for sharing clinical data;
supplying clinical data of a clinical trial subject patient who has obtained consent to share the clinical data for the clinical trial; and
Clinical trial relay method comprising the step of recording the supply history of the clinical data in a block chain.
The method of claim 1, wherein the step of registering on the system comprises:
generating a private key and a public key of the clinical trial requesting institution, patient, and medical institution;
transmitting the private keys of the clinical trial requesting institution, the patient, and the medical institution to the clinical trial requesting institution device, the patient device, and the medical institution device, respectively;
A clinical trial relay method comprising the step of obtaining consent for sharing medical information from a patient device.
3. The method of claim 2,
A clinical trial relay method, characterized in that both consent to sharing medical information and consent to sharing clinical data are required in order to supply the clinical data.
4. The method of claim 3,
The clinical trial relay method further comprising the step of obtaining consent to share additional clinical data in order to supply additional clinical data of a clinical trial subject patient who has consented to the sharing of the medical information and consent to the sharing of clinical data.
According to claim 1, wherein the step of supplying the clinical data of the candidate patient who has obtained consent to share the clinical data,
transmitting, by a data server, the contents of consent for sharing the clinical data to store the contents of consent for sharing the clinical data; and
Clinical trial relay method comprising the step of receiving and transmitting the clinical data from the data server.
The method of claim 1, wherein the searching for the candidate patient comprises:
obtaining the number of candidate patients for each medical institution by searching for candidate patients matching the test conditions; and
Clinical trial relay method comprising the step of obtaining approval from the medical institution.
The method of claim 1,
The test conditions include patient information, medical institution information, diagnosis history information, medication history information, genetic mutation information, genetic test information, test result information, allergy and side effects information, vaccination history information, biosignal information, and legal infectious disease information. Clinical trial relay method comprising one or more of.
The method of claim 7, wherein the genetic mutation information,
A clinical trial relay method comprising the name of the mutated gene or the exon ID of the mutated gene.
The method of claim 1, wherein the step of recording the supply history in a block chain comprises:
generating a supply history transaction based on a hash value of the supply history information and clinical data; and
Recording the supply history transaction in a blockchain,
The supply history information includes at least one of a supply time stamp, a clinical trial requesting institution that has received clinical data, a medical institution that has sent clinical data, approval information, content of consent for sharing clinical data, and test conditions,
The clinical trial relay method, characterized in that the hash value of the clinical data is a value calculated by applying the clinical data to a hash function.
10. The method of claim 9,
Receiving a forgery verification request of the clinical data; and
The clinical trial relay method further comprising the step of verifying whether or not forgery by comparing the hash value of the clinical data recorded in the block chain with the hash value of the supplied clinical data.
A computer-readable recording medium in which a computer program is recorded for performing the clinical trial relay method according to any one of claims 1 to 10.
In a clinical trial relay system including a platform server that communicates with a node that is a participant in a blockchain network, the node includes a clinical trial requesting institution device, a medical institution device, and a patient terminal,
The platform server,
By receiving a registration request from the clinical trial requesting institution device, the medical institution device and the patient terminal, the clinical trial requesting institution, the patient, and the medical institution performing the clinical trial are registered in the system;
receiving the clinical trial conditions planned by the clinical trial sponsoring organization from the device of the clinical trial sponsoring organization, and searching for a candidate patient matching the clinical trial conditions;
When the candidate patient is found, the candidate patient's consent is obtained by transmitting the candidate patient's consent request for sharing clinical data to the patient terminal,
Supplying clinical data of clinical trial subjects who have obtained consent to share the clinical data for the relevant clinical trial, and
A clinical trial relay system, characterized in that the supply history of the clinical data is recorded in a block chain.
13. The method of claim 12,
The clinical trial relay system is a clinical trial relay system, characterized in that the sharing of the clinical data through a smart contract (smart contract).

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