Leveraging Blockchain Technology for Informed Consent Process and Patient Engagement in a Clinical Trial Pilot.

Autor:	Mak BC; Department of Clinical Operations, Boehringer Ingelheim Canada Ltd./Ltée, Burlington, ON, Canada., Addeman BT; International Business Machines (IBM), Markham, ON, Canada., Chen J; International Business Machines (IBM), Yorktown Heights, NY, USA., Papp KA; K. Papp Clinical Research and Probity Medical Research Inc., Waterloo, ON, Canada., Gooderham MJ; SKiN Centre for Dermatology, Peterborough, ON, Canada., Guenther LC; The Guenther Dermatology Research Centre, London, ON, Canada., Liu Y; Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA., Broedl UC; Global Clinical Development & Operations, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany., Logger ME; Department of Clinical Operations, Boehringer Ingelheim Canada Ltd./Ltée, Burlington, ON, Canada.
Jazyk:	angličtina
Zdroj:	Blockchain in healthcare today [Blockchain Healthc Today] 2021 Oct 15; Vol. 4. Date of Electronic Publication: 2021 Oct 15 (Print Publication: 2021).
DOI:	10.30953/bhty.v4.182
Abstrakt:	Objective: Despite the implementation of quality assurance procedures, current clinical trial management processes are time-consuming, costly, and often susceptible to error. This can result in limited trust, transparency, and process inefficiencies, without true patient empowerment. The objective of this study was to determine whether blockchain technology could enforce trust, transparency, and patient empowerment in the clinical trial data management process, while reducing trial cost. Design: In this proof of concept pilot, we deployed a Hyperledger Fabric-based blockchain system in an active clinical trial setting to assess the impact of blockchain technology on mean monitoring visit time and cost, non-compliances, and user experience. Using a parallel study design, we compared differences between blockchain technology and standard methodology. Results: A total of 12 trial participants, seven study coordinators and three clinical research associates across five sites participated in the pilot. Blockchain technology significantly reduces total mean monitoring visit time and cost versus standard trial management (475 to 7 min; P = 0.001; €722 to €10; P = 0.001 per participant/visit, respectively), while enhancing patient trust, transparency, and empowerment in 91, 82 and 63% of the patients, respectively. No difference in non-compliances as a marker of trial quality was detected. Conclusion: Blockchain technology holds promise to improve patient-centricity and to reduce trial cost compared to conventional clinical trial management. The ability of this technology to improve trial quality warrants further investigation. Competing Interests: Boehringer Ingelheim supported this research. Baldwin C. Mak, Yi Liu, Uli C. Broedl, and Marianne E. Logger are employees of Boehringer Ingelheim. Bryan T. Addeman and Jia Chen are employees of IBM. Lyn C. Guenther receives clinical research support from Boehringer Ingelheim; Kim A. Papp consults, participates in steering committees and advisory boards, and receives clinical research grants and honoraria from Boehringer Ingelheim; Melinda J. Gooderham consults, speaks, participates on advisory boards, and receives clinical research and institutional funding from Boehringer Ingelheim. Boehringer Ingelheim provided the sole source of funding that supported this work. (© 2021 The Authors.)
Databáze:	MEDLINE
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