USA – Trials without clinical sites offer chance for improved access, generalizability

The COVID-19 pandemic has fueled the rise of clinical trials without clinical sites and opened the door to continuing these innovative models after the public health crisis has faded. While these trials offer the potential to expand access and the generalizability of results, there are also some limitations to conducting drug trials in this format.
 
In a special communication in JAMA Internal Medicine, Steven R. Cummings, MD, director of the San Francisco Coordinating Center and research scientist at the California Pacific Medical Center Research Institute, outlined the different designs for trials without clinical sites, the benefits and barriers, and the lingering research questions.
 
“The pandemic and the [Food and Drug Administration] have enabled people to be innovative and creative. The article is essentially a toolbox to help people think differently,” Cummings said in an interview…