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

ABSTRACT: Blockchain is a novel data architecture characterized by a chronological sequence of blocks in a decentralized manner. We aimed to evaluate the real-world feasibility of a blockchain-based dynamic consent platform (METORY) in a decentralized and multicenter trial. The study consisted of three visits (i.e., screening and 2 follow-up visits) with a 2-week interval. Each subject was required to report the self-measured body temperatures and take a virtual investigational drug by entering the unique drug code on the application. To simulate real-world study settings, two major (i.e., changes in the schedule of body temperature measurement) and three minor protocol amendments (i.e., nonsignificant changes without any changes in the procedures) were set. Overall study completion rates, proportio

SUBMITTER: Huh KY 

PROVIDER: S-EPMC9099134 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature