Evaluation of a blockchain‐based dynamic consent platform (METORY) in a decentralized and multicenter clinical trial using virtual drugs

Huh, Ki Young; Moon, Seol Ju; Jeong, Sang-Un; Kim, Minji; Yang, Wooseok; Jeong, Myeonggyu; Kim, Min‐Gul; Lee, SeungHwan

doi:10.1111/cts.13246

Cited by 10 publications

(14 citation statements)

References 30 publications

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“…Conveying proper understanding and ensuring security to the study participants are both crucial elements in eConsent. The results of the clinical trial revealed that informed consent that subjects gave did not always mean accurate understanding of the contents (25). The results were contradictory to the subjective feeling of understanding ("The app adequately acknowledged and provided information to let me know the progress of my action.")…”

Section: Discussionmentioning

confidence: 88%

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METORY: Development of a Demand-Driven Blockchain-Based Dynamic Consent Platform Tailored for Clinical Trials

et al. 2022

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The recent advent of the dynamic consent concept intensified the data integrity issue in clinical trials. Incorporating blockchain technology into a dynamic consent platform can be a feasible solution. Due to various clinical trial settings, a demand-driven development strategy is required. We developed a blockchain-based dynamic consent platform named METORY tailored for clinical trials. The platform consisted of three parts: web and mobile application user interface, study management platform, and blockchain platform. Hyperledger Fabric, an enterprise-grade private blockchain framework, was used to integrate blockchain into the study consent platform. We conducted user acceptance tests and applied feedback to the improvement of the platform. Identity and role-based access control was constructed by combining mobile-application-based certificate system and access control functionalities in Hyperledger fabric. Data were encrypted using SHA-256 prior to transmission to blockchain server and TLS protocol was used for in-transit encryption. File-system level encryption was separated implemented within the security measures from Amazon RDS. Users' experience in the clinical trial was acceptable in the ease and usefulness of the platform.

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Section: Discussionmentioning

confidence: 88%

“…The final platform was implemented in an actual decentralized and multicenter clinical trial using virtual drugs (ClinicalTrials.gov identifier: NCT05047016) (25). The study consisted of 2-week visits and home-based procedures.…”

Section: User Experience In the Multicenter Clinical Trialmentioning

confidence: 99%

METORY: Development of a Demand-Driven Blockchain-Based Dynamic Consent Platform Tailored for Clinical Trials

et al. 2022

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“…In addition, dynamic consent problems have been highlighted, including data readability and accessibility [126]. The authors of [127] constructed a blockchain‐based architecture for dynamic consent and tested its real‐world viability by using virtual drugs in a decentralized, multicentre clinical trial. Throughout the research, two major and three minor protocol adjustments were planned to imitate real‐world study conditions.…”

Section: Current Micro Applications In Clinical Trialsmentioning

confidence: 99%

Blockchain for applications of clinical trials: Taxonomy, challenges, and future directions

et al. 2022

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Patient enrollment, data sharing, and data privacy are enormous medical challenges for clinical trial studies. In recent years, blockchain technology has drawn the attention of various researchers and institutes. As a new and innovative distributed ledger technology, blockchain can be critical to addressing these challenges, thus making clinical research transparent and building public trust fairly and openly. However, the existing literature lacks a comprehensive survey on the adoption of blockchain in clinical trials. To fill the research void, this paper presents a punctilious taxonomy of blockchain technology in clinical trials according to the literature. This taxonomy comprises decentralized scenarios, decentralized practices, blockchain types, deployment methods, and consensus algorithms. The results show that blockchain technology can cover all aspects of the clinical trial study in a decentralized, secure, transparent manner. Besides, some open research challenges of blockchain are categorized into three groups: technical challenges, security challenges, and organizational challenges. Moreover, some recent blockchain projects, micro applications in clinical trials, and several research areas or technologies for future research and development are discussed.

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“…12 In a previous study, we developed a blockchain-based electronic consent application named METORY and evaluated the application in a DCT scenario. 15,19 We integrated an electronic diary module into METORY to manage DCT procedures in a single application. The application can keep logs for the study procedures, and investigators can analyze the adherence to study procedures with the log.…”

Section: Introductionmentioning

confidence: 99%

“…Such minimal restrictions can enable the analysis of real-world behaviors of the participants and were used to evaluate the participants' understanding of informed consent. 15 To investigate the feasibility of DCT, we conducted a pilot clinical trial in participants with functional constipation symptoms. We designed a full DCT with "lowrisk" alternatives (e.g., drug to dietary supplements and patients to participants with mild symptoms) to evaluate practical feasibility while reducing risks to participants.…”

Section: Introductionmentioning

confidence: 99%

Feasibility study for a fully decentralized clinical trial in participants with functional constipation symptoms

Huh,

Chung,

Park

et al. 2023

Clinical Translational Sci

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Decentralized clinical trials (DCTs) leverage digital technologies to reduce dependency on study sites and intermediaries. DCT should be balanced with accessibility and data reliability while meeting regulatory requirements. Here, we conducted a pilot study for functional constipation symptoms to investigate the feasibility of DCT. The study was an open, fully remote, randomized clinical trial in participants who had functional constipation symptoms. Electronic consent was obtained remotely, and study volunteers were screened through web‐based questionnaires. Subjects were randomized to either receive Lactobacillus and vitamin C supplements or vitamin C alone in a 1:1 ratio, which were delivered directly to subjects. Subjects kept track of bowel diaries daily during the 1‐week baseline and 2‐week treatment period using mobile applications. Bowel symptoms and the validity of the records were descriptively evaluated. A total of 30 subjects were randomized and completed the study. A total of 26.7% of subjects resided outside of the metropolitan area. Two‐week Lactobacillus treatments increased the number of defecations (+0.80 vs. +0.46 times per week) and decreased the defecation time (‐3.94 h vs. ‐1.62 h) compared to the comparator group. Overall, 67.1% of bowel diary records were completed in accordance with the schedule while 32.9% were not. Implementation of DCTs can facilitate geographic accessibility but should be guaranteed for data reliability. Prompt detection of errors and response using objective metrics would be required.

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Evaluation of a blockchain‐based dynamic consent platform (METORY) in a decentralized and multicenter clinical trial using virtual drugs

Cited by 10 publications

References 30 publications

METORY: Development of a Demand-Driven Blockchain-Based Dynamic Consent Platform Tailored for Clinical Trials

METORY: Development of a Demand-Driven Blockchain-Based Dynamic Consent Platform Tailored for Clinical Trials

Blockchain for applications of clinical trials: Taxonomy, challenges, and future directions

Feasibility study for a fully decentralized clinical trial in participants with functional constipation symptoms

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