Blog

With observations of National Hispanic Heritage Month kicking off on September 15, this year’s events will have special resonance for a team of Oregon Health & Science University (OHSU) researchers who are working to bring the benefits of clinical trials to more persons in underserved communities.

Decentralized clinical trials represent the shift towards implementing virtual research studies using digital health tools to gather data and monitor patient activity. During the COVID-19 pandemic, the clinical industry experienced significant disruption to traditional practices. To mitigate the spread of coronavirus, officials executed temporary guidance that limited person-to-person contact and forced many on-site physical clinical trials to a halt.

As stakeholders in pain research and pain management across the U.S. observe Pain Awareness Month this September, an ACRP Fellow and long-time volunteer is among the voices calling for more attention to be aimed at this vital but often-overlooked area of healthcare.

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.