The landscape of decentralized clinical trials (DCTs): focusing on the FDA and EMA guidance.

ABSTRACT: Decentralized clinical trials (DCTs) consist of off-site trial-related procedures referred to as decentralized elements. We aimed to provide an overview of the landscape of DCTs by comparing regulatory guidance reports and analyzing decentralized elements from clinical trial registries. Two guidance reports on DCTs published by the U.S. Food and Drug Administration and the European Medicines Agencies were summarized and analyzed. Both guidance publications commonly emphasized an assessment of the appropriateness of decentralized elements along 2 axes: patient safety and data integrity. DCT cases were identified from ClinicalTrials.gov by searching with 6 keywords: decentralized, remote, mobile, digital, virtual, and hybrid. Cases where the keyword was used in a non-DCT context, such as dig

SUBMITTER: Park J 

PROVIDER: S-EPMC10990725 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature