US government proposes rules to increase transparency of clinical trials

The US Department of Health and Human Services (HHS) proposed new rules on Wednesday that would increase the number of clinical trials that drugmakers, medical device companies and academic researchers are required to report. "We owe it to every participant and the public at large to support the maximal use of this knowledge for the greatest benefit to human health," remarked National Institutes of Health (NIH) director Francis Collins.

Specifically, under the proposed rules, any researcher receiving funding from the National Institutes of Health (NIH) would be compelled to make their study results available on ClinicalTrials.gov and report summary results within a year of study completion. Meanwhile, safety data would not have to be disclosed for studies conducted in the absence of NIH funding, but researchers would still be required to report other data.

The NIH estimated that the proposals, if approved, would result in the release of study data for about 650 additional studies each year. At present, the NIH and HHS estimate that about 178 000 studies are currently registered on ClinicalTrials.gov, although study summaries are only available for about 15 000 studies.

"This proposed rule would close an important gap, making additional information about clinical studies of investigational drugs, medical devices and biological products available to the public," commented FDA Commissioner Margaret A. Hamburg, adding "it would help eliminate unnecessary duplicative trials, advance biomedical innovation, and provide the public with a much richer understanding about the clinical trials for these products."

Commenting on the news, Harlan Krumholz, head of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation, said "this is a great day for research in America." Krumholz further remarked "NIH is exhibiting extraordinary leadership in exerting their influence to promote the responsible conduct of research for anyone receiving their funds. It's a day to applaud these actions."

However, Kay Dickersin, director of the Center for Clinical Trials at the Johns Hopkins Bloomberg School of Public Health, stated "the proposals take important steps toward greater transparency, but there are also disappointments." Dickersin praised the proposed requirement that results would have to be reported for studies of additional uses of FDA-approved drugs, but suggested that the lack of a requirement for researchers to reveal details of study protocols could permit drugmakers to conceal unfavourable results.

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