The Department of Health and Human Services (HHS), the parent department of the National Institutes of Health (NIH), has issued proposed rules concerning the transparency of clinical trials data (H/T Nature News, ScienceInsider). The proposed rules should be published in the Federal Register soon, and with the 90 day comment period, submissions will likely be due around February 19. NIH also released a Draft Policy, and is asking for comments by February 19.
The proposed rules are quite lengthy (over 400 pages); so lengthy that it might be folly to consider the NIH Draft Policy as an effective summary. The main purpose of both is to increase the amount of data that is reported and available to the public (through ClinicalTrials.gov). Adverse effects and negative results would be disclosed under these proposed policies.
However, as NIH Director Collins explains in a blog post, the NIH policy goes further than the HHS proposed rules. The policy would apply to all clinical intervention trials that NIH funds (not just drugs), while the HHS rules are focused on summary data of certain clinical trials for drugs and therapies.
While an intention behind both policies is to close reporting loopholes, it’s not clear how effective the new policies will be in addressing the significant under-reporting of clinical trials data. Ideally more results will be submitted to ClinicalTrials.gov and more results will be made available faster than they currently are. But reporting on these policies suggests that the amount of data still not reporting is quite large, and these new policies may make only a dent.