Posted on 15 November 2021
Over 3000 clinical trials that fall under the oversight of the US Food and Drug Administration (FDA) have not reported their results despite being legally obliged to do so, according to a recent analysis published in the Journal of the American Medical Association (JAMA).
Drug companies and research institutions have a track record of withholding clinical trial results if they show that a drug is ineffective or has harmful side effects. A STAT investigation in 2015 documented numerous examples of this, such as the case of the anticancer drug ganetespib by Synta Pharmaceuticals, which was associated with serious adverse effects in 13 out of 37 patients and one death.
Reporting requirements were strengthened in 2017, yet despite this, only 75% of due trial results have been reported to the federal database – a list of overdue trials is freely viewable in the FDAAA trial tracker, a website created by researchers in the UK (the FDA itself does not publicly track compliance with reporting rules).
The FDA can fine institutions that don’t report trial results on time, yet so far have not imposed even a single fine, even thought the FDAAA tracker estimates they could have collected over $25 billion by now. More frustrating still, the JAMA study found that since 2013, the FDA sent only 58 preliminary warnings over late results, yet over 9 in 10 of these warnings led to trial results being quickly provided. This suggests that it’s not particularly difficult to get institutions to comply with the law – the FDA simply isn’t using its enforcement tools. The National Institutes of Health (NIH) could also support the FDA by threatening to withdraw future grants from non-compliant grantees.
When FDA rattles its sabre, drug makers and universities start reporting overdue trial results: https://www.statnews.com/pharmalot/2021/11/12/fda-clinical-trials-transparency-disclosure/
Strengthening the FDA’s Enforcement of ClinicalTrials.gov Reporting Requirements: http://jamanetwork.com/article.aspx?doi=10.1001/jama.2021.19773