The US Department of Health and Human Services (HHS) on Friday issued a final rule that will require scientists and companies to publicly disclose more details on a wider range of medical research studies, even if the study results are deemed disappointing, as part of efforts "to make information about clinical trials widely available." According to the department, the new rule expands legal requirements for submitting registration and results information for clinical trials involving FDA-regulated drug, biological and device products. Meanwhile, the US National Institutes of Health (NIH) also unveiled a complementary policy for registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the HHS's final rule.
NIH director Francis Collins said that while there are more than 224 000 clinical studies listed on ClinicalTrials.gov, researchers have "a disappointing track record" in making the findings available when the data are unfavourable. Collins suggested the new steps "will help maximise the value of clinical trials," adding that failure to follow them "may jeopardise future grant funding" for the institutions involved, not just individual researchers.
According to the NIH, expanding the registration information in ClinicalTrials.gov improves people's ability to find studies they may be able to participate in, while more disclosure about study results, "whether positive or negative, may help inform healthcare providers and patients regarding medical decisions." Moreover, the NIH said additional information may help researchers avoid duplicating studies, as well as help them to focus on areas of need and to improve trial designs, which will "ultimately [advance] the development of clinical interventions."
Requirements under the final rule issued by the HHS do not apply to Phase I trials of drug and biological products, or small feasibility studies of device products. The final rule specifies how and when information collected in a clinical trial must be submitted to ClinicalTrials.gov, but does not dictate how studies should be designed or conducted, or what data must be collected. However, the NIH policy applies to all NIH-funded trials, including Phase I clinical studies of FDA-regulated products and small feasibility device trials.
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