Prototype of running clinical trials in an untrustworthy environment using blockchain
Open accessAbstract
Monitoring and ensuring the integrity of data within the clinical trial process is currently not always feasible with the current research system. We propose a blockchain-based system to make data collected in the clinical trial process immutable, traceable, and potentially more trustworthy. We use raw data from a real completed clinical trial, simulate the trial onto a proof of concept web portal service, and test its resilience to data tampering. We also assess its prospects to provide a traceable and useful audit trail of trial data for regulators, and a flexible service for all members within the clinical trials network. We also improve the way adverse events are currently reported. In conclusion, we advocate that this service could offer an improvement in clinical trial data management, and could bolster trust in the clinical research process and the ease at which regulators can oversee trials.
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Blockchain adoption has been posited to have positive connotations in clinical trial management, DNA data transmission, remote patient monitoring, drug discovery, biomarker development, and preventive healthcare.
“For example, blockchain adoption has been posited to have positive connotations in clinical trial management (Wong et al., 2019), DNA data transmission (S.J. Lee et al., 2018), remote patient monitoring (Griggs et al., 2018;Dwivedi et al., 2019) as well as drug discovery, biomarker development, and preventive healthcare (Mamoshina et al., 2018).”
From Blockchain in healthcare: A systematic literature review, synthesizing framework and future research agenda (2020) · cites this paper as Wong et al., 2019
Studies have focused on improving processes for timely updates and reporting for adverse events.
“Additionally, prior studies have focused on improving processes for timely updates (Wang & Song, 2018) and reporting for adverse events (Wong et al., 2019).”
From Blockchain in healthcare: A systematic literature review, synthesizing framework and future research agenda (2020) · cites this paper as Wong et al., 2019
Societal constraints include possibility of collusion for fabricating data and inability to control clinical malpractice.
“For example, there may be a possibility of collusion for fabricating data (Wong et al., 2019) or a healthcare system may be constrained by an inability to control clinical malpractice (Zhang et al., 2018)”
From Blockchain in healthcare: A systematic literature review, synthesizing framework and future research agenda (2020) · cites this paper as Wong et al., 2019
Certain studies pointed to socially-oriented concerns about public data sharing and users' trust in governments.
“However, certain studies have also pointed to more sociallyoriented concerns about public data sharing (Wong et al., 2019) and users' trust in governments (Dhagarra et al., 2019).”
From Blockchain in healthcare: A systematic literature review, synthesizing framework and future research agenda (2020) · cites this paper as Wong et al., 2019
Researchers have called for extending technical boundaries of framework development to improve scalability and functionality.
“Further, in order to improve the scalability (Zhang et al., 2016) and functionality (Wong et al., 2019) of previously proposed frameworks, researchers have called for the need to extend the current technical boundaries of framework development, e.g. by consideration of novel blockchain platforms (Rahmadika & Rhee, 2019).”
From Blockchain in healthcare: A systematic literature review, synthesizing framework and future research agenda (2020) · cites this paper as Wong et al., 2019
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References 15 · Cited by 160
Research works printed but not linked: 12
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- Authors
- Wong, D. R., Bhattacharya, S., & Butte, A. J.
- Affiliations
- University of California, San Francisco (US)
- Corresponding author
- Butte, Atul J.
- Venue
- Nature Communications
- Published
- 2019-02-22
- Volume
- 10
- Issue
- 1
- Pages
- 917-917
- ISSN
- 2041-1723 (ISSN-L)
- PMC
- PMC6384889
- OpenAlex
- W2917431061
- Cited by
- 160
- References
- 15
- Citations by year
- 2026: 6 · 2025: 11 · 2024: 20 · 2023: 29 · 2022: 27 · 2021: 29 · 2020: 27 · 2019: 11
- FWCI
- 29.24
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Nature Communications (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- RePEc: Research Papers in Economics (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- eScholarship (California Digital Library) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by)
- Funders
- National Institutes of Health (HHSN316201200036W)
- National Institute of Allergy and Infectious Diseases (HHSN316201200036W)
- Topics
- Physical Sciences › Computer Science › Information Systems › Blockchain Technology Applications and Security
- Physical Sciences › Computer Science › Information Systems › Blockchain Technology in Education and Learning
- Health Sciences › Health Professions › Health Information Management › Electronic Health Records Systems
- Keywords
- blockchain, clinical trials, clinical trial data integrity, data immutability, data traceability, audit trail, adverse event reporting, clinical trial data management, regulatory oversight
- MeSH terms
- Proof of Concept Study, Clinical Trials as Topic, Data Collection, Delivery of Health Care, Humans, Medical Audit, Quality Control
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