Drugmakers Must Report Clinical Trial Results Once Kept Secretby
NIH rule requires disclosure even if FDA didn’t approve drug
Researchers risk losing NIH funding if they don’t comply
Pharmaceutical companies will no longer be able to keep confidential their clinical trial results for experimental drugs that aren’t approved for patient use.
Under a rule released Friday, the National Institutes of Health will require drugmakers to post their results on clinicaltrials.gov, the agency’s online database that lists publicly and privately funded studies. Researchers currently are required to disclose results for key trials on drugs that were approved for sale by the U.S. Food and Drug Administration, though not all do.
Companies and academic researchers that don’t comply may risk losing NIH funding for future clinical trials. Twelve drugmakers released a median of 65 percent of relevant clinical trial findings for selected treatments, according to a study published in November in the medical journal BMJ Open. The rule would expand the requirement to research on unapproved drugs.
“The money that we have to spend on research needs to be spent on really good research,” FDA Commissioner Robert Califf said Thursday on a call with reporters. “If it’s not a good clinical trial, we’re saying you’ve got to put it out there anyway. It’s going to lead people to do things more thoughtfully, and I think the quality of the trials will get better.”
NIH Director Francis Collins said the research community has a “disappointing track record” of making trial results available.
In one of the worst examples of secrecy, Eliot Spitzer, then the attorney general of New York state, sued GlaxoSmithKline Plc, accusing it of suppressing research that showed links between its antidepressant Paxil and increased risk of suicide in young people. Glaxo settled with Spitzer for $2.5 million and agreed to publish its research online.
NIH first proposed the rule in 2014, and the final version released Friday is similar to the draft, said Kathy Hudson, the deputy director for science outreach and policy at NIH. Researchers also will have to publicly disclose clinical trial design, which Collins said may prevent those conducting trials from changing the statistical analysis to produce better results.
Medical-device clinical trials also come under the rule, which takes effect Jan. 18, and researchers have 90 days to comply.