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The Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) published final rules in September that will dramatically change the way clinical trials are funded and reported.
The regulations require that all NIH-funded trials be registered in the clinicaltrials.gov database within 21 days of enrolling the first participant. Although investigators have been required to register their trials in the database since 2007, they have a “disappointing record” of doing so, said NIH Director Francis Collins, MD, PhD.
The HHS regulations require that all sponsors of Food and Drug Administration-regulated trials, including pharmaceutical and device manufacturers, submit their results no more than a year after the trial ends. The requirement also covers studies for investigational products that fail to meet their endpoints. The NIH regulations expand that requirement for agency-funded phase 1 and behavioral intervention studies, as well as certain device studies, which the HHS rules exclude.
Companies and institutions that fail to comply with the new regulations face potential civil or criminal actions as well as fines. In addition, NIH will also withhold future clinical trial funding.
As Collins and Deputy Director for Science, Outreach and Policy Kathy L. Hudson, PhD, wrote in a blog about the new regulations: “We will be taking the implementation of the (HHS) regulation and of the NIH policy very seriously and have put in place robust enforcement and compliance measures.”
However, they also noted the difficulty in submitting information into the current database, and promised that the agency would be updating it to improve data entry.
The new rules also require that applicants submit ideas in response to a request for applications rather than as investigator-initiated grant applications. Such applications will spell out trial design requirements and are part of the agency’s efforts to “reengineer the process by which clinical investigators develop ideas for new trials,” agency staff wrote in a column published in the Journal of the American Medical Association (JAMA).
Investigators must also describe how they plan to report the results of their trials and submit their protocols and original statistical analysis plans with the summary results. This is designed to prevent “P-value hacking,” Collins told reporters, “where people sort of shop around for a statistical test to give them the P value that they love.&rdquo
NIH is also developing a standardized electronic system to manage funded trials and ensure accountability as well as improve data collection. The system will be used for strategic planning and “identifying the best, safest, and least burdensome ways to gather important data to improve human health,” the authors of the JAMA article wrote.
The new rules take effect January 18, 2017, for newly funded NIH trials. Sponsors will have 90 days to comply.