ore than 90 patient advocates, including representatives of 20 organizations, are urging the National Institutes of Health to take “immediate action” to ensure better reporting of results from human testing of new treatments.
The advocates recently called on the agency to correct its “failure to demand accountability” from institutions that flout a federal law requiring public posting of outcomes of many clinical trials.
“Patient advocacy groups across the US are very concerned with the disregard for human life, patient safety, transparency, and accountability the NIH, and the FDA, have shown by not enforcing timely reporting of” clinical trial results, the advocates wrote in a January letter to NIH director Dr. Francis Collins.
The advocates acted in response to a STAT investigation published in December that showed many of the nation’s leading medical research institutions had routinely violated the trial-reporting statute. The failure to report results on time — or at all — prevents doctors and patients from learning information that can be vital to gauge the safety and efficacy of drugs and medical devices, STAT reported.
In an analysis of data from the NIH repository, ClinicalTrials.gov, STAT found that the worst offenders included top recipients of NIH funds, such as Stanford University, the University of Pennsylvania, and the University of Pittsburgh. Each disclosed clinical trial results either late or not at all at least 95 percent of the time since 2008, when reporting became mandatory.
Pharmaceutical companies performed better overall — but still broke the reporting law routinely. Even NIH staff scientists failed to report results as required about three-quarters of the time.
Collins recently replied that NIH was “deeply committed to transparency and to increasing access to research results and data.” He said compliance should improve after new rules clarify the reporting requirements for both NIH grantees and private companies regulated by the Food and Drug Administration. The rules, under development for years, are expected to be issued this spring.
The chief author of the letter was Suzan Shinazy, founder of the Medical Error Transparency Plan, based in Bakersfield, Calif. Other signers included representatives from the Consumer Reports Safe Patient Project, the Connecticut Center for Patient Safety, Californians for Patient Rights, the National Physicians Alliance, and Washington Advocates for Patient Safety.
“We also ask that you issue a public report on how you will correct these urgent issues of patient safety,” the advocates wrote.
Collins did not respond directly to that request, but told the advocates, “we are making significant progress to ensure that those who must abide by the law understand and fulfill their legal obligations.”