New Federal Rules Toughen up Clinical Trial Transparency
The new rule aims to expand the sharing of summary data from clinical trials. Now researchers are now required to disclose all clinical trials, whether successful or not
The US Department of Health and Human Services (HHS) and the US National Institutes of Health (NIH) announced today, September 16th, strict new clinical-trial disclosure laws requiring, for the first time, that researchers report the design and results of all clinical trials and empowers the government to enforce penalties for those that do not comply.
Drug companies and academic researchers will have to step up their public reporting of clinical trial results under new federal policies. Researchers can no longer submit an unsolicited idea, but must respond to a request for applications that will include specific design requirements. The goal is to cut down on the number of “small crappy studies,” that don’t include sufficient numbers of patients or veer off from the original study plan, NIH staffers say. The agency wants to “reengineer the process by which clinical investigators develop ideas for new trials,” NIH officials explain in a commentary today in The Journal of the American Medical Association (JAMA).
Under the new rule, trials must be registered on ClinicalTrials.gov within 21 days of enrolling their first patient — researchers can no longer wait for the results of their trails to report their data. Companies will now have to report results not only for approved products, but also for mid- and late-stage (phase II and III) trials of FDA-regulated drugs and devices that haven’t yet been approved and may never reach the market. The new NIH’s companion policy includes a requirement that NIH-funded researchers register phase I trials: these typically include small numbers of healthy volunteers and test a therapy’s safety instead of its efficacy. They also include trials that do not involve a FDA-regulated product, such as behavioural interventions. At the moment, even many major academic medical centers aren’t publishing trial results of NIH-funded trials within the required time frame.
The new rules go into effect 18 January 2017 and trial sponsors will have 90 days to begin complying; companies can request an exemption for up to 2 years if FDA hasn’t yet approved sale of the drug. The NIH policy covers studies funded after 18 January 2017. Trial sponsors who fail to comply could face FDA fines and suspension of NIH funding for clinical research.
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