WO2022098158A1 - Système et procédé de relai d'essai clinique à l'aide d'un réseau de chaîne de blocs - Google Patents

Système et procédé de relai d'essai clinique à l'aide d'un réseau de chaîne de blocs Download PDF

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WO2022098158A1
WO2022098158A1 PCT/KR2021/016046 KR2021016046W WO2022098158A1 WO 2022098158 A1 WO2022098158 A1 WO 2022098158A1 KR 2021016046 W KR2021016046 W KR 2021016046W WO 2022098158 A1 WO2022098158 A1 WO 2022098158A1
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clinical trial
clinical
patient
data
information
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PCT/KR2021/016046
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Korean (ko)
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정세영
홍경표
임가현
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서울대학교병원
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    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16B—BIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY
    • G16B20/00—ICT specially adapted for functional genomics or proteomics, e.g. genotype-phenotype associations
    • G16B20/20—Allele or variant detection, e.g. single nucleotide polymorphism [SNP] detection
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H80/00—ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L9/00—Cryptographic mechanisms or cryptographic arrangements for secret or secure communications; Network security protocols
    • H04L9/08—Key distribution or management, e.g. generation, sharing or updating, of cryptographic keys or passwords
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L9/00—Cryptographic mechanisms or cryptographic arrangements for secret or secure communications; Network security protocols
    • H04L9/08—Key distribution or management, e.g. generation, sharing or updating, of cryptographic keys or passwords
    • H04L9/0816—Key establishment, i.e. cryptographic processes or cryptographic protocols whereby a shared secret becomes available to two or more parties, for subsequent use
    • H04L9/0819—Key transport or distribution, i.e. key establishment techniques where one party creates or otherwise obtains a secret value, and securely transfers it to the other(s)
    • H04L9/0825—Key transport or distribution, i.e. key establishment techniques where one party creates or otherwise obtains a secret value, and securely transfers it to the other(s) using asymmetric-key encryption or public key infrastructure [PKI], e.g. key signature or public key certificates
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L9/00—Cryptographic mechanisms or cryptographic arrangements for secret or secure communications; Network security protocols
    • H04L9/50—Cryptographic mechanisms or cryptographic arrangements for secret or secure communications; Network security protocols using hash chains, e.g. blockchains or hash trees

Definitions

  • 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.
  • clinical trials have a number of difficulties in recruiting patients to confirm the safety and efficacy of the drug.
  • 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);
  • a non-hospital eg, a pharmaceutical company
  • There are difficulties such as the patient's fear of exposing their medical information.
  • Patent Document 1 Korean Patent 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.
  • 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.
  • the clinical relay method includes: registering a clinical trial sponsor, a patient, and a medical institution performing a clinical trial in 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.
  • both consent to sharing medical information and consent to sharing clinical data may be required in order to supply the clinical data.
  • 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
  • the step of supplying the clinical data of the candidate patient who has obtained the consent to share the clinical data includes the content of consent for sharing the clinical data so that the data server stores the content of consent for sharing the clinical data. transmitting; and receiving and transmitting the clinical data from the data server.
  • 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.
  • 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 information on legal infectious diseases.
  • 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.
  • 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.
  • 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 may record a computer program for performing the clinical trial relay method according to the above-described embodiments.
  • a clinical trial relay system includes a platform server that communicates with a node that is a participant in a blockchain network, wherein the node includes a clinical trial requesting institution device, a medical institution device, and a patient 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.
  • 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 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. .
  • 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.
  • 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.
  • 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.
  • FIG. 1 is a schematic configuration diagram of a clinical trial relay system according to an embodiment of the present invention.
  • FIG. 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.
  • FIG. 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.
  • FIG. 4 is a flowchart of a clinical data supply process according to an embodiment of the present invention.
  • FIG. 5 is a system flow diagram of a clinical data verification process according to an embodiment of the present invention.
  • FIG. 6 is a system flow diagram of a process of supplying additional clinical data according to an embodiment of the present invention.
  • FIG. 7 is a system flow diagram of a process of supplying additional clinical data according to another embodiment of the present invention.
  • FIG. 8 is a flowchart of a clinical trial relay method according to an embodiment of the present invention.
  • a “node” is a participant in a blockchain network, and includes various communicationable electronic devices such as servers, personal computers, smart phones, and terminals.
  • FIG. 1 is a schematic block diagram of a clinical trial relay system 1 according to an embodiment of the present invention.
  • 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 may have aspects that are entirely hardware, entirely software, or partially hardware and partially software.
  • the clinical trial relay system 1 may collectively refer to hardware equipped with data processing capability and operating software for driving the same.
  • terms such as “unit”, “module,” “device,” or “system” are intended to refer to a combination of hardware and software run by the hardware.
  • the hardware may be a data processing device including a central processing unit (CPU), a graphic processing unit (GPU), or another processor.
  • 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.
  • CRO contract research organization
  • 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, 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.
  • the medical institution device 20 may generate off-chain data of the target patient that satisfies a medical information standard.
  • 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.
  • FHIR Fast Healthcare Interoperability Resources
  • 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 requesting institution device 10 , the medical institution device 20 , and the patient terminal 30 operate as individual entities participating in the platform service 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.
  • 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).
  • 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.
  • the structured data is data stored in a fixed field, for example, a relational database, a spreadsheet, or the like.
  • 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.
  • semi-structured data is data that 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.
  • off-chain data stored in data server 40 may include one or more of the details in the following table.
  • 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 of the relevant disease Sang Byeong-myung Corporal Code Name (KCD 7) corporal code Corporal Code (KCD 7) dosing history
  • 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 codes for prescription 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 Usage information of prescribed medications genetic mutation gene name of the gene in which the mutation occurred
  • 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.
  • S3 simple storage service
  • GFS Google file system
  • Microsoft Office Online provided by Microsoft Corporation
  • 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
  • the blockchain platform server 50 may perform an operation corresponding to the request and provide a result for the request.
  • block chain platform server 50 may perform an operation of recording the history of relaying clinical trials in the block chain.
  • 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.
  • 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.
  • 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.
  • the blocks may include information on software executing the system 1, block creation time, node-related information (eg, IP address of the blockchain platform server 50, etc.).
  • the blockchain distributed storage of each node is a predetermined storage space inside the node for distributing and storing the blockchain results generated by the blockchain network in 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.
  • 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.
  • 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).
  • MSP membership service provider
  • CA Certificate Authority
  • 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.
  • the on-chain data stored in the blockchain may include one or more of the detailed items in Table 2 below.
  • 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 prescription 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.
  • FIG. 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.
  • 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.
  • the block chain platform server 50 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).
  • the blockchain platform server 50 allocates a security key to the medical institution (S214).
  • the security key assigned to the medical institution device includes a private key and a public key.
  • 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).
  • 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 a willingness to share the patient's 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 to share 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).
  • the step (S230) includes a 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).
  • the patient device 30 provides the patient with a screen for writing a medical information sharing agreement.
  • 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).
  • 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.
  • 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.
  • 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 .
  • 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 .
  • 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).
  • 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).
  • 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.
  • 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.
  • the medical institution device 20 Upon receiving the preparation instruction for sharing with system subscribers, the medical institution device 20 configures the patient's medical information set (S236).
  • 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).
  • 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 .
  • 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.
  • FIG. 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.
  • 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).
  • 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.
  • the test condition may be metadata of information stored in the data server 40 .
  • 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).
  • 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).
  • the step (S320) may further include the step (S326) of generating the approval and plan of the clinical trial performing institution.
  • the approval of the clinical trial conducting institution may be performed only for a medical institution with a relatively large number of candidate patients.
  • the clinical trial sponsoring institution 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.
  • 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.
  • the patient device 30 may transmit a registration request including a medical information sharing agreement to the blockchain platform server 50 .
  • the blockchain platform server 50 may check the patient's medical institution while registering the patient's security key (224) (S234).
  • 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.
  • FIG. 4 is a flowchart of a clinical data supply process according to an embodiment of the present invention.
  • 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).
  • 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 block chain 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.
  • the patient device 30 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.
  • the blockchain platform server 50 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).
  • 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).
  • 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 .
  • 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).
  • the clinical trial requesting institution device 10 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.
  • 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.
  • 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).
  • 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, content of consent for 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).
  • 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.
  • FIG. 5 is a system flow diagram of a clinical data verification process according to an embodiment of the present invention.
  • 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 .
  • 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.
  • FIG. 6 is a system flow diagram of a process of supplying additional clinical data according to an embodiment of the present invention.
  • 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 ).
  • the blockchain platform server 50 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.
  • the step (S620) 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 (S621).
  • 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).
  • the block chain platform server 50 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).
  • 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.
  • the consent may be in the form of a snapshot, but is not limited thereto.
  • 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 agreement eg, a snapshot
  • 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).
  • the data server 40 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 .
  • 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).
  • the clinical trial requesting institution device 10 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 the clinical trial target patient in the blockchain network (S650).
  • the step (S650) may include the step (S651) 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).
  • 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.
  • FIG. 7 is a system flow diagram of a process of supplying additional clinical data according to another embodiment of the present invention.
  • FIG. 7 Since the embodiment of FIG. 7 is similar to the embodiment of FIG. 6 , differences will be mainly described.
  • the data server 40 may store additional clinical data in advance.
  • the blockchain platform server 50 may receive a request for sharing and supply of additional clinical data (S610).
  • 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 .
  • 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).
  • clinical data including genetic test information is stored in the data server 40
  • the data server 40 stores the consent content (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.
  • 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.
  • 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.
  • the number of patients for each medical institution may be obtained (S321 to S325).
  • the blockchain platform server 50 confirms consent to share clinical data with the candidate patient (S420).
  • 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).
  • the clinical trial sponsor may conduct a clinical trial using a patient with an obesity gene as an experimental group and a patient without an obesity gene as a control based on the presence or absence of an obesity gene through genetic testing.
  • 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).
  • 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.
  • test requesting institution is a pharmaceutical company, CRO, etc., 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).
  • 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.
  • 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.
  • the clinical trial requesting institution device 10 transmits a clinical data supply request to the blockchain 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 block chain platform server 50 .
  • the clinical data includes blood test information of the patient.
  • 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).
  • 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.
  • 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.
  • 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 may be performed by a computing device including a processor (eg, the clinical trial relay system 1 of FIG. 1 ).
  • a computing device including a processor (eg, the clinical trial relay system 1 of FIG. 1 ).
  • the present invention will be described in more detail based on embodiments performed by the clinical trial relay system 1 of FIG. 1 .
  • FIG. 8 is a flowchart of a clinical trial relay method according to an embodiment of the present invention.
  • 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 ).
  • the block chain platform server 50 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.
  • 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.
  • the clinical trial relay method includes receiving a clinical data sharing request (S820) and obtaining patient consent (S830).
  • the patient's consent when the request for sharing is the first for a corresponding clinical trial, 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).
  • 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 ).
  • 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.
  • 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.
  • 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.
  • 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. .
  • the clinical trial sponsor can dramatically reduce the cost of recruiting clinical trial patients.
  • the patient in the clinical trial relay system of the present invention, can select some or all of the items to be shared among his or her medical information in the process of consenting to sharing medical information, and the medical information provided to the clinical trial sponsor is It can be verified whether it has been forged or altered, minimizing the risk of patient information leakage.
  • 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.

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Abstract

La présente invention porte, selon des modes de réalisation, sur un procédé de relais d'essai clinique et sur un système de relais d'essai clinique, le procédé comprenant les étapes consistant : à enregistrer, dans un système, une agence de demande d'essai clinique, un patient et une institution médicale effectuant des essais cliniques ; à rechercher un patient candidat qui correspond aux conditions de l'essai clinique planifié par l'agence de demande d'essai clinique ; à acquérir l'accord du patient candidat correspondant concernant le partage de données cliniques, si le patient candidat est trouvé ; à fournir des données cliniques concernant le patient cible d'essai clinique pour lequel un accord concernant le partage de données cliniques a été acquis ; et à enregistrer un historique d'approvisionnement sur la chaîne de blocs.
PCT/KR2021/016046 2020-11-05 2021-11-05 Système et procédé de relai d'essai clinique à l'aide d'un réseau de chaîne de blocs WO2022098158A1 (fr)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116633933A (zh) * 2023-07-24 2023-08-22 吉林大学第一医院 一种基于区块链的医疗设备信息管理系统
WO2024049956A1 (fr) * 2022-08-31 2024-03-07 Snickerdoodle Labs, Inc. Techniques pour fournir un protocole de partage de données basé sur la confidentialité

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2018533123A (ja) * 2015-09-10 2018-11-08 エフ．ホフマン−ラ ロシュ アーゲーＦ． Ｈｏｆｆｍａｎｎ−Ｌａ Ｒｏｃｈｅ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ 統合された臨床ケアのための情報科学プラットフォーム
KR20190086172A (ko) * 2018-01-12 2019-07-22 전북대학교산학협력단 블록체인을 이용한 임상시험 자원관리 방법 및 시스템
KR20190134315A (ko) * 2018-05-25 2019-12-04 (주)혁신마케팅 인공지능 기반 임상시험 참여 대상자 매칭 시스템
KR20200084736A (ko) * 2019-01-03 2020-07-13 주식회사 바이오크 임상시험 데이터 변경 이력 추적 방법
KR20200118312A (ko) * 2019-04-05 2020-10-15 주식회사 올리브헬스케어 임상시험참여자를 위한 스마트 e-컨센트 시스템 및 방법

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20100134259A (ko) * 2009-06-15 2010-12-23 윤인모 임상시험 지원방법 및 시스템
KR101398988B1 (ko) 2011-06-30 2014-06-30 김혁만 전자 증례기록지를 이용한 임상시험 서비스 시스템
KR20190118458A (ko) * 2018-04-10 2019-10-18 주식회사 메디블록 블록체인에 기반한 의료 정보 플랫폼을 제공하는 방법, 시스템 및 비일시성의 컴퓨터 판독 가능 기록 매체
KR102321476B1 (ko) * 2019-04-05 2021-11-02 이병일 관심질환 등록 기반의 스마트 임상시험 신청 시스템 및 방법

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2018533123A (ja) * 2015-09-10 2018-11-08 エフ．ホフマン−ラ ロシュ アーゲーＦ． Ｈｏｆｆｍａｎｎ−Ｌａ Ｒｏｃｈｅ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ 統合された臨床ケアのための情報科学プラットフォーム
KR20190086172A (ko) * 2018-01-12 2019-07-22 전북대학교산학협력단 블록체인을 이용한 임상시험 자원관리 방법 및 시스템
KR20190134315A (ko) * 2018-05-25 2019-12-04 (주)혁신마케팅 인공지능 기반 임상시험 참여 대상자 매칭 시스템
KR20200084736A (ko) * 2019-01-03 2020-07-13 주식회사 바이오크 임상시험 데이터 변경 이력 추적 방법
KR20200118312A (ko) * 2019-04-05 2020-10-15 주식회사 올리브헬스케어 임상시험참여자를 위한 스마트 e-컨센트 시스템 및 방법

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024049956A1 (fr) * 2022-08-31 2024-03-07 Snickerdoodle Labs, Inc. Techniques pour fournir un protocole de partage de données basé sur la confidentialité
CN116633933A (zh) * 2023-07-24 2023-08-22 吉林大学第一医院 一种基于区块链的医疗设备信息管理系统
CN116633933B (zh) * 2023-07-24 2023-09-19 吉林大学第一医院 一种基于区块链的医疗设备信息管理系统

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