Decentralized Clinical Trials in a Post-Pandemic Era

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.

It’s Time to Pay More Attention to Pain Research and Management

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.

Faster Drug Approvals by FDA Raise Concerns About Transparency and Beneficence in Clinical Trials

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.
Nadine H. Spring, PhD, CCRC, Director of Operations, SpringWell360 LLC

PIs Recognize Need for Greater Diversity in Trials, Feel Frustrated by Limitations

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.