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With recent studies from Oregon State University raising essential points about drug safety and research transparency in an era when the U.S. Food and Drug Administration seems to be approving drugs after fewer trials (accelerated approval) and releasing less data from those trials, one experienced principal investigator cautions that public perceptions of clinical research may take a hit.

With a new international guidance open for public comments, stakeholders in digital, hybrid, and fully decentralized clinical trials (DCTs) may feel a growing urgency to harmonize global regulations to prevent any roadblocks to adopting the technologies necessary to achieve the benefits of this approach.

Principal investigators interviewed for a recent academic dissertation recognized the need for greater diversity among participants in the clinical trials but are frustrated that the inclusion/exclusion criteria handed by sponsors often don’t match the real-life situations of the average patient in their practice with the condition of interest. In the forthcoming August issue of ACRP’s Clinical Researcher journal, these and other findings are detailed in a peer-reviewed article.

To better understand the current site landscape and the top challenges sites are facing, WCG created the 2023 Clinical Research Site Challenges Survey Report, in addition to recommendations for sites, sponsors, and CROs to better address study needs and the needs of the sites conducting those studies.

Untangling the web of regulatory expectations regarding who among sponsors, investigators, and vendors will be held responsible—and when and why—for different key aspects of decentralized clinical trials (DCTs) lies at the crux of comments submitted by the ACRP to the U.S. Food and Drug Administration (FDA) in response to their recent draft guidance on DCTs.