BioCentury
ARTICLE | Politics & Policy

FDA opens doors for digital tools to facilitate siteless trials, find new endpoints

September 19, 2019 11:21 PM UTC

In its latest steps to make clinical trials more representative of the real world, FDA plans to release draft guidance related to the implementation of siteless trials and the incorporation of new digital tools. The agency is also increasing its capacity to use machine learning and AI to identify new surrogate endpoints.

"We believe that more accessible clinical trials can facilitate participation by more diverse patient populations within diverse community settings where patient care is delivered and in the process, generate information that's more representative of the real world," Commissioner Scott Gottlieb said at the Bipartisan Policy Center conference on Monday...