• Ojasav Sehrawat, Peter A Noseworthy, Konstantinos C Siontis, Tufia C Haddad, John D Halamka, and Hongfang Liu.
• Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN. Electronic address: sehrawat.ojasav@mayo.edu.
• Mayo Clin. Proc. 2023 Sep 1; 98 (9): 140414211404-1421.

AbstractTraditional trial designs have well-recognized inefficiencies and logistical barriers to participation. Decentralized trials and digital health solutions have been suggested as potential solutions and have certainly risen to the challenge during the pandemic. Clinical trial designs are now increasingly data driven. The use of distributed clinical data networks and digitization has helped to fundamentally upgrade existing research systems. A trial design may vary anywhere from fully decentralized to hybrid to traditional on-site. Various decentralization components are available for stakeholders to increase the reach and pace of their trials, such as electronic informed consent, remote interviews, administration, outcome assessment, monitoring, and laboratory and imaging modalities. Furthermore, digital health technologies can be included to enrich study conduct. However, careful consideration is warranted, including assessing verification and validity through usability studies and having various contingencies in place through dedicated risk assessment. Selecting the right combination depends not just on the ability to handle patient care and the medical know-how but also on the availability of appropriate technologic infrastructure, skills, and human resources. Throughout this process, quality of evidence generation and physician-patient relation must not be undermined. Here we also address some knowledge gaps, cost considerations, and potential impact of decentralization and digitization on inclusivity, recruitment, engagement, and retention. Last, we mention some future directions that may help drive the necessary change in the right direction.Copyright © 2023 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

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