Clinicaltrials-dot-Gov-HHS-15Sep2023
From the memo:
This memo provides a request that the Department of Health and Human Services (HHS), working through the National Institutes of Health (NIH), use its rulemaking authority for ClinicalTrials.Gov to include data on the costs of human subject clinical trials.
The Secretary of Health and Human Services (HHS) can initiate a rulemaking process to expand the scope of the information disclosure requirements set forth in 42 U.S. Code § 282(j) to include the budget and actual amount spent on each clinical trial. This obligation can apply to any trial or subset of trials, such as trials funded in part by the federal government, interventional trials (instead of observational trials) that involve pharmaceutical drugs or therapies, trials used by the FDA in their medical reviews to approve products, trials that qualify for the U.S. Orphan Drug Tax Credit or trials that are undertaken to qualify for the FDA’s 505A Pediatric Extension.
The authority to promote this process is provided under 42 U.S. Code § 282 (j)(2)(A)(iii).