Gap in Regulatory Coverage Affects 5 to 16 Percent of Trials

Nineteen to 24 percent of trials are overlap trials, which study drugs, devices and have federal funding

WEDNESDAY, March 5, 2014 (HealthDay News) -- Human subjects protections (HSP) policies do not provide regulatory coverage for all clinical trials, while up to about a quarter of trials are considered overlap trials, according to a research letter published in the March 5 issue of the Journal of the American Medical Association.

The U.S. federal HSP policies include the U.S. Food and Drug Administration HSP regulations (FDA-regulated clinical investigation of drugs, biologics, and devices) and the Common Rule (human studies funded by federal entities). Deborah A. Zarin, M.D., from the National Institutes of Health in Bethesda, Md., and colleagues estimated the numbers of active U.S.-based clinical trials subject to these regulations. Data were obtained from records for active trials listing at least one U.S.-based facility.

The researchers estimated that 55 to 65 percent of the 23,936 sampled trials were covered only by FDA-HSP regulations; 6 to 10 percent were subject only to the Common Rule; and 19 to 24 percent were overlap trials that examined drugs and devices and had some federal funding. Five to 16 percent of trials were gap trials, which had no federal funding and examined interventions other than drugs or devices. Gap trial characteristics varied widely and included research in vulnerable populations.

"Our analysis provides the first quantitative estimate of the size of that gap in regulatory coverage, and also documents a large number of studies that are subject to both sets of regulations," the authors write.

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