HHS, NIH, FDA Propose New Rules To Enhance Clinical Trial Transparency

Federal agencies in the U.S. have proposed new rules to promote clinical trial transparency. The National Institutes of Health (NIH) announced the rules in a press release, stating that the Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM) regarding reporting requirements. The NIH states that the rules were developed in close consultation with the Food and Drug Administration (FDA). The major change to the rules is a requirement that more clinical trial results be reported including trials of unapproved, unlicensed, and uncleared products.

The new rules apply to trials subject to Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Clinical researchers who register clinical studies on ClinicalTrials.gov, operated by the National Library of Medicine, part of the National Institutes of Health, must submit summary results from all trials. Currently the database holds 178,000 trials, including some trials that are not subject to FDAAA, but only summary results for 15,000. The new rules seek to address this discrepancy.

The federal agencies state that the benefits of increased reporting include the unnecessary duplication of trials, both positive and negative clinical findings, and the establishment of trust in patients that their time and experience is put to good use in seeking effective treatments.

The NIH states that the proposed rules apply to certain interventional studies regulated by the FDA, but not to Phase 1 trials. The rules advise investigators on how to collect data, analyze it, and submit it to the database. The proposed rules do not affect study design or influence study execution. The NIH specified what interested parties may find in the additional rules: 

• Who is responsible for submitting required information
• An approach to decide which trials are subject to the new rules 
• The data sets required when registering new trials
• Procedures to follow if a delay in results submission is warranted 
• Rapid updating of several data elements at ClinicalTrials.gov
• Ways to correct errors in reporting 

NIH Director Francis S. Collins, M.D., PhD, said, “Medical advances would not be possible without participants in clinical trials. We owe it to every participant and the public at large to support the maximal use of this knowledge for the greatest benefit to human health. This important commitment from researchers to research participants must always be upheld.”