13Jan

FDA and NIH let clinical trial sponsors keep results secret and break the law

admin Jan 13, 2020

For 20 years, the U.S. government has urged companies, universities, and other institutions that conduct clinical trials to record their results in a federal database, so doctors and patients can see whether new treatments are safe and effective. Few trial sponsors have consistently done so, even after a 2007 law made posting mandatory for many trials registered in the database. In 2017, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) tried again, enacting a long-awaited “final rule” to clarify the law’s expectations and penalties for failing to disclose trial results. The rule took full effect 2 years ago, on 18 January 2018, giving trial sponsors ample time to comply. But a Science investigation shows that many still ignore the requirement, while federal officials do little or nothing to enforce the law.

Science examined more than 4700 trials whose results should have been posted on the NIH website ClinicalTrials.gov under the 2017 rule. Reporting rates by most large pharmaceutical companies and some universities have improved sharply, but performance by many other trial sponsors—including, ironically, NIH itself—was lackluster. Those sponsors, typically either the institution conducting a trial or its funder, must deposit results and other data within 1 year of completing a trial. But of 184 sponsor organizations with at least five trials due as of 25 September 2019, 30 companies, universities, or medical centers never met a single deadline. As of that date, those habitual violators had failed to report any results for 67% of their trials and averaged 268 days late for those and all trials that missed their deadlines. They included such eminent institutions as the Harvard University–affiliated Boston Children’s Hospital, the University of Minnesota, and Baylor College of Medicine—all among the top 50 recipients of NIH grants in 2019.

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.

McNeilly declined an interview request, but at the conference he discounted violations of ClinicalTrials.gov reporting requirements found by journalists and watchdog groups. “We’re not going to blanketly accept an entire list of trials that people say are noncompliant,” he said. Such determinations require “nonpublic information” submitted to the agency by trial sponsors. In response to Science’s findings, a spokesperson said an absence of posted results on ClinicalTrials.gov did not mean a trial sponsor has broken the 2007 law.

Yet that law and the 2017 final rule detail only a few exemptions that would allow trial sponsors to withhold results on the basis of nonpublic information. The very few registered trials that qualify for those exemptions are not flagged as violators by TrialsTracker or in Science’s analysis.

Source: https://www.sciencemag.org/news/2020/01/fda-and-nih-let-clinical-trial-sponsors-keep-results-secret-and-break-law

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