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Applying Blockchain Technology to Enhance Clinical Trial Recruitment.

ABSTRACT: Patient recruitment for clinical trials is known to be a challenging aspect of clinical research. There are multiple competing concerns from the sponsor, patient and principal investigator's perspectives resulting in most clinical trials not meeting recruitment requirements on time. Conducting under-enrolled clinical trials affects the power of conclusive results or causes premature trial termination. The Blockchain is a distributed ledger technology originally applied in the financial sector. Its features as a peer-to-peer system with publicly audited transactions, data security, and patient privacy are a good fit for the needs of clinical trials recruitment. The "Smart Contract" is a programmable self-executing protocol that regulates the blockchain transactions. Given current recruitment challenges, we have proposed a blockchain model containing multiple trial-based contracts for trial management and patient engagement and a master smart contract for automated subject matching, patient recruitment, and trial-based contracts management.

SUBMITTER: Zhuang Y

PROVIDER: S-EPMC7153067 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Applying Blockchain Technology to Enhance Clinical Trial Recruitment.

Zhuang Yan Y Sheets Lincoln R LR Shae Zonyin Z Chen Yin-Wu YW Tsai Jeffrey J P JJP Shyu Chi-Ren CR

AMIA ... Annual Symposium proceedings. AMIA Symposium 20190101

Patient recruitment for clinical trials is known to be a challenging aspect of clinical research. There are multiple competing concerns from the sponsor, patient and principal investigator's perspectives resulting in most clinical trials not meeting recruitment requirements on time. Conducting under-enrolled clinical trials affects the power of conclusive results or causes premature trial termination. The Blockchain is a distributed ledger technology originally applied in the financial sector. I ...[more]

PMID: 32308925

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Project description:BACKGROUND:Digital health technologies, including telemedicine, mobile health (mHealth), and remote monitoring, are playing a greater role in medical practice. Safe and accurate management of medical information leads to the advancement of digital health, which in turn results in a number of beneficial effects. Furthermore, mHealth can help lower costs by facilitating the delivery of care and connecting people to their health care providers. Mobile apps help empower patients and health care providers to proactively address medical conditions through near real-time monitoring and treatment, regardless of the location of the patient or the health care provider. Additionally, mHealth data are stored in servers, and consequently, data management that prevents all forms of manipulation is crucial for both medical practice and clinical trials. OBJECTIVE:The aim of this study was to develop and evaluate a tamper-resistant mHealth system using blockchain technology, which enables trusted and auditable computing using a decentralized network. METHODS:We developed an mHealth system for cognitive behavioral therapy for insomnia using a smartphone app. The volunteer data collected with the app were stored in JavaScript Object Notation format and sent to the blockchain network. Thereafter, we evaluated the tamper resistance of the data against the inconsistencies caused by artificial faults. RESULTS:Electronic medical records collected using smartphones were successfully sent to a private Hyperledger Fabric blockchain network. We verified the data update process under conditions where all the validating peers were running normally. The mHealth data were successfully updated under network faults. We further ensured that any electronic health record registered to the blockchain network was resistant to tampering and revision. The mHealth data update was compatible with tamper resistance in the blockchain network. CONCLUSIONS:Blockchain serves as a tamperproof system for mHealth. Combining mHealth with blockchain technology may provide a novel solution that enables both accessibility and data transparency without a third party such as a contract research organization.

Dataset Information

Applying Blockchain Technology to Enhance Clinical Trial Recruitment.

Publications

Applying Blockchain Technology to Enhance Clinical Trial Recruitment.

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