Regulatory readiness to facilitate the appropriate use of innovation in clinical trials: The case of decentralized clinical trial approaches

• Published in: Drug discovery today Vol. 29; no. 11; p. 104180
• Main Authors: de Jong, Amos J., Zuidgeest, Mira G.P., Santa-Ana-Tellez, Yared, de Boer, Anthonius, Gardarsdottir, Helga
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.11.2024
• Subjects: clinical trial innovation; decentralized clinical trials; regulation; regulatory readiness; regulatory science; clinical trial innovation; decentralized clinical trials; regulatory readiness; regulation; regulatory science
• ISSN: 1359-6446; 1878-5832; 1878-5832
• DOI: 10.1016/j.drudis.2024.104180

•Regulatory readiness can be defined as a timely response to innovation.•Decentralized clinical trials (DCT) take an innovative approach to trial operations.•Regulatory readiness might facilitate the appropriate use of DCT approaches.•Explorative research should be facilitated to collect data on the usefulness of DCTs.•Overregulation should be circumvented when establishing regulatory requirements. Methodological and operational clinical trial innovation is needed to address key challenges associated with clinical trials, including limited generalizability and (s)low recruitment rates. In this article, we discuss how appropriate implementation of innovative clinical trial approaches can be facilitated by a timely identification of, and response to, emerging situations and innovation by regulators (i.e. regulatory readiness) using decentralized clinical trial (DCT) approaches – in which trial activities are moved closer to participants and away from the investigative sites – as a case study example. Specifically, we discuss how explorative research (e.g. using regulatory sandboxes) can enable the collection of data on the usefulness of DCT approaches. Additionally, we argue that DCT approaches should be evaluated similarly to conventional clinical trials.