U.S. Proposes Greater Public Access to Clinical Trial Data
(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, 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," Margaret Hamburg, MD, 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.
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. Summaries of findings would generally be due within a year of an NIH-funded study's end. 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.
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 February 19, 2015.