U.S. Proposes Greater Public Access to Data From Clinical Trials

New rules would require even failed trials to publish summary of results

Thursday, November 20, 2014

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Clinical Trials

THURSDAY, Nov. 20, 2014 (HealthDay News) -- Two U.S. government agencies have proposed new rules that will make it easier for everyone to know whether a clinical trial was successful or not.

The proposed changes would expand the number of trials that are required to publish summaries of their results to ClinicalTrials.gov -- a publicly accessible database, according to the U.S. National Institutes of Health (NIH) and the U.S. Department of Health and Human Services.

"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," Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration, said in an NIH news release.

Hamburg said the new rules would also help to eliminate unnecessary duplication of clinical trials. This is particularly important when negative results -- findings that suggest the medication didn't work -- haven't been published about a drug that may be unsafe or ineffective, the NIH said.

Currently, there are 178,000 clinical trials registered in the United States and internationally. Some of those registered trials are completed, while others are still enrolling patients. Of those trials, just 15,000 include a summary of their results, according to the NIH.

"Medical advances would not be possible without participants in clinical trials," Dr. Francis Collins, director of the NIH, said in the news release. "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."

Summaries of findings would generally be due within a year of an NIH-funded study's end, according to the NIH. And, the new rules would require summaries even for unapproved, unlicensed, and uncleared products.

However, the NIH is not including phase 1 studies in the new reporting requirements. Phase 1 studies are generally quite small and are designed to test only the safety of a new drug or device (not its effectiveness), and establish a safe dose for humans, according to the U.S. National Library of Medicine.

It's expected that an extra 650 clinical trial summaries will be published each year under the new rules, according to the Associated Press.

Public comments on the proposed rule changes are being accepted through Feb. 19, 2015.

SOURCES: U.S. National Institutes of Health, news release, Nov. 19, 2014; Associated Press

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