“FDA and NIH Let Clinical Trial Sponsors Keep Results Secret and Break the Law”, 2020-01-13 (; backlinks; similar):
The rule took full effect 2 years ago, on 2018-01-18, 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 2019-09-25, 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.
…Contacted for comment, none of the institutions disputed the findings of this investigation. In all 4768 trials Science checked, sponsors violated the reporting law more than 55% of the time. And in hundreds of cases where the sponsors got credit for reporting trial results, they have yet to be publicly posted because of quality lapses flagged by ClinicalTrials.gov staff (see sidebar).
Although the 2017 rule, and officials’ statements at the time, promised aggressive enforcement and stiff penalties, neither NIH nor FDA has cracked down. FDA now says it won’t brandish its big stick—penalties of up to $12,103 a day for failing to report a trial’s results—until after the agency issues further “guidance” on how it will exercise that power. It has not set a date. NIH said at a 2016 briefing on the final rule that it would cut off grants to those who ignore the trial reporting requirements, as authorized in the 2007 law, but so far has not done so…NIH and FDA officials do not seem inclined to apply that pressure. Lyric Jorgenson, NIH deputy director for science policy, says her agency has been “trying to change the culture of how clinical trial results are reported and disseminated; not so much on the ‘aha, we caught you’, as much as getting people to understand the value, and making it as easy as possible to share and disseminate results.” To that end, she says, ClinicalTrials.gov staff have educated researchers about the website and improved its usability. As for FDA, Patrick McNeilly, an official at the agency who handles trial enforcement matters, recently told an industry conference session on ClinicalTrials.gov that “FDA has limited resources, and we encourage voluntary compliance.” He said the agency also reviews reporting of information on ClinicalTrials.gov as part of inspections of trial sites, or when it receives complaints. 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.
…It also highlights that pharma’s record has been markedly better than that of academia and the federal government.
…But such good performance shouldn’t be an exception, Harvard’s Zarin says. “Further public accountability of the trialists, but also our government organizations, has to happen. One possibility is that 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.”