“I’m expecting a flood of trials to get registered,” FDA Commissioner Robert Califf
Reporter: Aviva Lev-Ari, PhD, RN
WASHINGTON — Researchers will have to publicly report the results of many more clinical trials, including some for drugs and devices that never reach the market, under new government rules announced Friday.
The federal rules, which also require more complete reporting of deaths, clarify and strengthen a 2007 law that requires researchers to report results of many human studies of experimental treatments for ailments such as diabetes, cancer, and heart disease.
Government officials said the new rules are meant to improve compliance with requirements for public registration of trials and posting of data on the ClinicalTrials.gov website. But advocates for transparency in clinical research cautioned that the success of the new rules, which take effect Jan. 18, 2017, will depend on the vigor of government enforcement.
A recent analysis in the journal BMJ found that GlaxoSmithKline, Paxil’s manufacturer, failed to disclose 2001 data showing the drug to be no more effective than a placebo, and was linked to increased suicide attempts by teens.
Biden threatens funding cuts for researchers who fail to report clinical trial results
“Under the law, it says you must report. If you don’t report, the law says you shouldn’t get funding,” Biden said, citing a STAT investigation that found widespread reporting lapses.