Last year, we published an article (see HERE) on the reporting of clinical trial results in Europe. Now, an article in Science magazine, published under the provocative title “FDA and NIH let clinical trial sponsors keep results secret and break the law” (Jan 13, 2020), reports that researchers from Oxford University in the UK found that only 41% of clinical trials reported their results to the US clinical trials register, a figure very similar to the one recorded by the European Union’s clinical trial register (read HERE). Both regions have breached the rules that require trial sponsors to report results to the Administration within a year of completion, whether results are positive or negative.
Possible consequences in medicine of clinical trials silenced in great scale
The article continues, explaining why it is vital that new clinical trials report their results on time: “The violations cover trials in virtually all fields of medicine, and the missing or late results offer potentially vital information for the most desperate patients. For example, in one long-overdue trial, researchers compared the efficacy of different chemotherapy regimens in 200 patients with advanced lymphoma; another—nearly 2 years late—tests immunotherapy against conventional chemotherapy in about 600 people with late-stage lung cancer.”
Clinical trials silenced – Cultural problems and weak attitude of FDA and NIH authorities
Dr. Deborah Zarin, who previously headed ClinicalTrials.gov says that the Science study shows failures, and that if it was a priority for the leadership of NIH, “then they could ensure that high-quality, timely reporting happened all of the time.” She adds that the problem persists because trial sponsors, funders and trialists frequently see reporting to ClinicalTrials.gov as “an annoying administrative and perhaps legal burden, not a scientific imperative.” Zarin concludes that it is a matter of culture and that, “[h]uman nature being what it is, people follow the requirements when forced to do” According to the article though, “NIH and FDA officials do not seem inclined to apply that pressure.”
Zarin concluded, “Further public accountability of the trialists, but also our government organizations, has to happen. One possibility is that the FDA and NIH will be shamed into enforcing the law. Another possibility is that sponsors will be shamed into doing a better job. A third possibility is that ClinicalTrials.gov will never fully achieve its vital aspirations.”
The issue has objective ethical problems that should be resolved by FDA and NIH.