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All Applicable Clinical Trials Are Already Compliant with Clinicaltrials.gov: FDA
(Thursday, December 7, 2023) According to the FDA, all clinical trials that should be compliant with the clinicaltrials.gov regulations are already compliant. In a surprising blog this week, the FDA Commissioner pointed out the major flaw in the complaint that most clinical trials are not compliant with clinical trial reporting requirements by stating that only 15% of the trials registered with clinicaltrials.gov are required to report their results per the law. And they already do that, based on the FDA analysis. The FDA Amendment Act (FDAAA) of 2007 made it mandatory that all clinical trials register with clinicaltrials.gov, and report results within 1 year of being completed. However, a quick search on the clinicaltrials.gov website shows that only about 15% of the trials indeed post results per the law. Independent groups have claimed that most of the clinical trials on clinicaltrials.gov are non-compliant either by not reporting results or reporting them late. However, the FDA points out that only 15% of the trials are required to post results and most of them who are required to do so, already do. Although the FDA would like to see all trials report results, it does not have the mandate to enforce that. Of the trials that are required to post results, the FDA has found about 100 non-compliance events and in all cases, when the FDA notified the offenders, everyone posted the results and came into compliance. The FDA blog is silent on the delay in posting results but apparently FDA does not consider delays in posting results to be a significant issue. The FDA has not had to impose fines on any company for non-compliance with clinicaltrials.gov regulations. A search on clinicaltrials.gov confirms the FDA statement. It is important to understand the intent of the law. The clinical trial reporting requirements were designed to create transparency for interventional trials with drugs and biologics that were above Phase 1. Of the interventional trials listed on clinical trials, only about 35% fit that criteria of which only about half are conducted in the US bringing us to the 15% applicable studies. Most trials with results posted on clinicaltrials.gov belong to this group of 15%. The results from the other 85% of studies may also be important but the transparency laws don’t apply to them so reporting their results is voluntary. This is another case where misperceptions and misinformation may dominate common knowledge. A cynical view could be that this also demonstrates that about 85% of trials registered on clinicaltrials.gov are not whose results would have an impact on clinical benefit, at least not in the near perceived future. And that may be correct. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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