Clinical Trial Results Remain Under-Reported Publicly
[Posted on: Thursday, November 19, 2015]

Three bioethicists, one each from NYU, Harvard and Yale, published a review of public reporting of clinical trial data used to support FDA approval by 10 major pharma companies of 15 new drugs in 2012. It was found that results from only about a third of the clinical trial trials were published. A total of 318 clinical trials were used to support the market approval of 15 drugs; only about 54 of these trials were published in peer reviewed journals. The most common omissions were for the Phase 2 and Phase 3 clinical trials. Almost all the studies were registered with clinicaltrials.gov, but results were posted only for about 20% of the trials. Companies varied in their transparency with three being 100% transparent for the trials used to support product approval, while others were less transparent. There are some interesting limitations of this report. First, the authors chose only the top pharma companies, presumably assuming that large companies have more resources to publish data in a timely manner compared to smaller companies with limited resources. It would be interesting to see if similar trends prevail across companies of all sizes. Second, the analysis is limited to one year, 2012. The authors acknowledged both these limitations and plan to address these in future reviews. Clinical trial results need to be reported within 12 months of completion of the trial, with extensions of up to one year granted in some cases. Since it takes about a year for FDA to approve a drug after submission of an NDA, it is very interesting how these companies stayed non-compliant. The clinical trial reporting laws include stiff monetary penalty on companies that fail to submit results to clinicaltrials.gov, starting from $10,000 per violation, and if the violation is not addressed within 30 days of notification, an additional monetary penalty of $10,000 per day the violation is not addressed. There are no reports of such penalties being imposed on the companies identified in this article. The reasons for this are unknown. May be the authors can forward the list of defaulters to the NIH and ask NIH to impose the penalties required under the law. Overall, the article talks about limitations of the laws regarding clinical trial result reporting. The article was well publicized; let’s see if the government is paying attention.

Expert Opinion: Mukesh Kumar
VP, RA, Amarex Clinical Research