The Department of Health and Human Services and National Institutes of Health have issued a final rule and companion policy, respectively, providing more information about clinical trials to the public in an effort at increased transparency.
The HHS final rule, which takes effect on Jan. 18, 2017, expands the legal requirements for submitting registration and results information for clinical trials involving Food and Drug Administration-regulated drug, biological and device products, including adverse event information. However, the requirements do not apply to Phase 1 trials of drug and biological products or small feasibility studies of device products.
A companion NIH policy, which also goes into effect on January 18, calls on pharmaceutical companies and research institutions conducting clinical trials that are funded in whole or in part by the NIH to ensure that these trials are registered at ClinicalTrials.gov, which is managed by NIH’s National Library of Medicine, and that results information of these trials is submitted to ClinicalTrials.gov. The policy applies all NIH-funded trials and includes Phase 1 trials of drug and biological products, as well as small feasibility studies of device products and behavioral studies, which are not covered by the HHS final rule.
According to NIH, additional information about the scientific results of trials—both positive and negative—helps to inform healthcare providers and patients regarding medical decisions. Further, armed with this data, researchers can avoid unnecessary duplication of studies, focus on areas in need of research and improve study designs, resulting in advances in the development of clinical interventions.
“Clinical trials are the way in which we learn what works and what doesn’t work, and yet it’s not always been easy to see the results or even to sometimes know what trials are being conducted,” said NIH Director Francis Collins, MD. “The HHS final rule and the additional NIH policy on top of that now will make this much more transparent.”
Collins added that typically the results for as many as a third of NIH-funded trials are not published. “Oftentimes, they are trials that turned out negative, but you want to know that, too,” he said. “This requires now that, 12 months after collecting the last data point on the trial participants, the results in a summary form need to be posted on ClinicalTrials.gov.”
While the final rule specifies how and when information collected in a clinical trial must be submitted to ClinicalTrials.gov, NIH emphasizes that it does not dictate how clinical trials should be designed or conducted, or what data must be collected.
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