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

Blockchain in Healthcare Today October 14, 2021
Baldwin C. Mak, PhD, Bryan T. Addeman, BSc, MBA, Jia Chen, PhD, Kim A. Papp, MD, PhD, FRCPC, FAAD, Melinda J. Gooderham, MSc, MD, FRCPC, Lyn C. Guenther, MD, FRCPC, FAAD, Yi Liu, PhD, Uli C. Broedl, MD, Marianne E. Logger, BSc

ABSTRACT

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...

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