The U.S. Department of Health and Human Services (HHS) announced a proposal on Wednesday that will require researchers to publicize all clinical trial results in a public database, including those that failed to win FDA approval.
Current rules require researchers to publish the summary of their studies involving FDA-regulated drugs, biological products, and devices. However, the rule is not applicable to studies that failed during their initial phase.
Under the new proposed rules, researchers would submit a summary of their studies to ClinicalTrials.gov whether it wins FDA approval or not. The website is accessible to the public and maintained by the National Institutes of Health (NIH). Another proposal suggests that all clinical trials funded by the NIH be published in the database.
NIH officials forecasted an additional 600 trial results to be added to the database if the proposal is implemented. Currently, ClinicalTrials.gov lists about 178,000 clinical trials, but only 15,000 (or less than 10 percent) submitted the results, according to Bloomberg.
Federal officials aim to increase public awareness and to prevent other researchers from duplicating studies leading to negative results.
"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," said FDA Commissioner Margaret A. Hamburg, M.D, in a press release. "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."
The new proposal received positive comments from groups supporting increased transparency.
"This is a great day for research in America," said Harlan Krumholz, who has been an advocate for greater transparency, to Forbes. "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."
The proposal is open for public comment until Feb. 19.
