FDA, NIH allowed clinical trial sponsors to keep results secret

Institutions that conduct clinical trials — such as pharmaceutical companies and universities — still do a poor job following a law that requires them to post clinical trial results on a government website, and the government agencies that are supposed to enforce that law are turning their heads, according to an investigation by Science.

A 2007 law made it mandatory for institutions that conduct clinical trials to post the trial results on ClinicalTrials.gov, a website run by the National Institutes of Health, within a year of completing a trial. That way, physicians and patients can look at the results to see whether new treatments are safe and effective. 

But clinical trial sponsors have ignored the law and either submitted results late or not at all. 

In 2017, the NIH and the FDA enacted a "final rule" to clarify what the law entails and what the penalties are for institutions that fail to post trial results. That final rule took effect in January 2018, but Science's investigation shows that many trial sponsors still ignore the law, and that the NIH and FDA do little to nothing to enforce it. 

Science examined 4,758 clinical trials that should have posted results on the NIH website. Out of all the trials, Science found that clinical trial sponsors violated the reporting law more than 55 percent of the time. 

The institutions that broke the clinical trial reporting law include such respected institutions as Boston Children's Hospital, affiliated with Harvard University, and Baylor College of Medicine. MD Anderson Cancer Center and Mayo Clinic both failed to report results on time or at all in about two-thirds of their trials, Science reported. 

None of the institutions disputed Science's findings when it reached out for comment. 

The violations reportedly occur in virtually all fields of medicine, and the missing or late results contain potentially vital information for patients most in need, such as those with cancer.

The FDA told Science it wouldn't enforce the policy until after the agency issues further guidance on how it will exercise its power, but hasn't set a date for when that will happen. 

The NIH reportedly said in 2016 that it would cut off grants for clinical trial sponsors who ignore the reporting requirements, but it has not. 

Lyric Jorgenson, NIH deputy director for science policy, told Science that the NIH has been "trying to change the culture of how clinical trial results are reported and disseminated; not so much on the 'aha, we caught you,' as much as getting people to understand the value, and making it as easy as possible to share and disseminate results."

Patrick McNeilly, an FDA official who handles trial enforcement matters, reportedly said that the "FDA has limited resources, and we encourage voluntary compliance."

Read the full investigation here

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