By Jill Drachenberg, Managing Editor, AHC Media
The U.S. Department of Health and Human Services (HHS) released its final rule pertaining to the registration of clinical trials and reporting of trial results on its public database, ClinicalTrials.gov. The new rule comes two years after HHS’ initial Notice of Proposed Rulemaking (NPRM) on the subject.
At the same time, the National Institutes of Health (NIH) published a complementary final policy on submitting clinical trial proposals.
HHS considered nearly 900 comments received during the NPRM comment period on ways to create more transparency in clinical trial data and to provide more data to the public. Highlights of the final rule include the following:
- Summary results of studies should be posted to ClinicalTrials.gov no later than one year after the date of completion, including studies on FDA-regulated products that have not yet been approved or cleared by the agency. Reporting can be delayed for up to two years if either “1) a drug, biological, or device product studied in the clinical trial is not yet approved, licensed, or cleared for marketing by the FDA and is still under development by the manufacturer; or 2) that the manufacturer is the sponsor of the clinical trial and has sought or will seek approval, licensure, or clearance for a new use of a product studied in the trial within one year,” according to HHS.
- Additional informational elements about the study must be submitted to ClinicalTrials.gov, including race and ethnicity of study subjects (if known), and the full protocol. The final rule also requires additional adverse even reporting, including all-cause mortality.
- Clinical trial information must be updated at least annually. Narrative summaries are not required at the time, pending further study into how narratives can be written without sounding biased or promotional.
- New consequences of noncompliance, including FDA fines and suspension of NIH funding.
The NIH policy applies to all clinical trials that receive any NIH funding, “including Phase I clinical trials of FDA-regulated products and small feasibility device trials as well as products that are not regulated by the FDA, such as behavioral interventions,” according to HHS. The new policy includes the following:
- “Good Clinical Practice” training for investigators and NIH staff who conduct or oversee trials to ensure knowledge of all steps of the trial process, from study design to reporting results.
- Instead of submitting investigator-initiated grant applications, investigators will have to respond to trial-specific “Funding Opportunity Announcements” that will “include review criteria that focus on the rationale, design, and operational and analysis plans, all of which will inform assessments of proposed studies.”
- Use of a protocol template developed by NIH and FDA to ensure all necessary clinical trial information is included.
Both policies go into effect Jan. 17, 2017. More information on the policies, including expert analysis and industry reaction, will be available in the November issue of IRB Advisor.