HHS makes it harder for clinical researchers to avoid sharing trial data

The Department of Health and Human Services finalized a rule that expands and clarifies what clinical-trial data legally needs to be made public. The goal is to help scientists, doctors and patients learn more about ongoing research and potentially ease access to experimental treatments. A 2007 law required certain universities and manufacturers to report their results. But some exemptions and lax enforcement caused few to follow through. The final rule clarifies that most interventional trials involving drug, biological and device products need to be registered on ClinicalTrials.gov, and summary results for the studies need to be submitted within a year of a trial’s completion. Clinicaltrials.gov is run by the National Institutes of Health. The website offers clinical trial results and information on registered trials. It was established so patients could see whether they were eligible for experimental treatments. The final rule, which will go into effect Jan. 18, 2017, also requires applicable trial results to be submitted even if the product being tested is not yet approved by the Food and Drug Administration.