Stat: New rule on clinical trial reporting doesn’t go far enough


The clinical trial industry, which I work in, is in crisis.

Roughly half of clinical trials go unreported. Industry-sponsored trials are four times more likely to produce positive results than non-industry trials. And even when trials are reported, the investigators usually fail to share their study results: nearly 90 percent of trials on ClinicalTrials.gov lack results.

Failure to report clinical trial results puts patients in danger. Here’s one example of that: GlaxoSmithKline, the maker of the antidepressant Paxil, recently paid $3 billion for failing to disclose trial data showing that Paxil was not only no more effective than placebo but was also linked to increased suicide attempts among teenagers. The effectiveness of statins, the Tamiflu anti-flu medicine, antipsychotics, and other drugs have come under question due to improperly reported data. Without complete disclosure of trial results, physicians can’t make informed decisions for their patients.

A recently passed final rule from the Department of Health and Human Services now requires that all NIH-sponsored clinical trials be reported on ClinicalTrials.gov. A complementary policy from the National Institutes of Health covers registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded trials, including those not covered by the final rule.

Unreported trials are subject to daily fines of $11,833. Researchers have 90 days after the rule is enacted on January 18, 2017 to comply with it. Excellent summaries of the rule have been published by the NIH and in the New England Journal of Medicine.

The final rule should help address some of the troubling trends in the clinical trial industry. It clears up ambiguous reporting requirements and explicitly requires investigators to submit clinical trial results, adverse events, and statistical methods. These are steps in the right direction that could limit the unscientific practices plaguing the trial industry.

But the final rule doesn’t go far enough, mainly because FDA lacks the staff and the political will to adequately enforce it. As STAT reported in December 2015, the FDA had never levied a single fine for clinical trial reporting violations. Representatives from the FDA cite legal complexities and lack of employees, yet critics have also pointed out the FDA is effectively on the pharmaceutical industry’s payroll. Under the Prescription Drug User Fee Act, the FDA supplements its budget by charging pharmaceutical companies drug application fees that totaled $855 million in fiscal year 2015.

The current FDA commissioner, Dr. Robert Califf, has said that the FDA will not be adding staff to enforce the final rule. That’s a mistake. How else can we expect the rule to be enforced? I work in a research group that conducts more than a dozen clinical trials and know firsthand that researchers don’t have the impetus to report their trials unless there are strong incentives to do so — like enforcement and the threat of fines.

In a perfect world, the FDA would receive more funding to hire employees so it could independently enforce this policy. In the meantime, researchers can check the reporting practices of their own institutions or sign a petition to support the Alltrials campaign. Another project called OpenTrials, a collaboration between Open Knowledge International and the University of Oxford Data Lab, aims to “locate, match, and share all publicly accessible data and documents, on all trials conducted, on all medicines and other treatments, globally.” It is seeking volunteers to contribute clinical trial data.

I know from personal experience that clinical trial reporting can be tedious and seemingly unrewarding work. But the transparent exchange of scientific data is integral to evidence-based medicine and public health. While the new final rule is a step in the right direction, the public and the research community also need to support efforts like AllTrials and OpenTrials.

Chris Cai is a clinical research coordinator at Massachusetts General Hospital in Boston.

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