Study examines gap in federal oversight of clinical trials
Wednesday, March 5, 2014 - 08:30
in Health & Medicine
An analysis of nearly 24,000 active human research clinical trials found that between 5 percent and 16 percent fall into a regulatory gap and are not covered by two major federal regulations. These trials studied interventions other than drugs or devices (e.g., behavioral, surgical). The authors write that their analysis provides the first quantitative estimate of the size of the gap in regulatory coverage, and also documents a large number of studies that are subject to both sets of regulations.