Jessica Jayasuriya, MJLST Managing Editor
The Food and Drug Administration Amendments Act of 2007 requires that parties responsible for clinical trials submit clinical trial inform to the Director of NIH no later than one year after either the end date or the estimated end date of the trial.
However, several sources are alleging that Stanford University, Memorial Sloan Kettering Cancer Center, the University of Pennsylvania, the University of Pittsburgh, the University of California San Diego, and other major medical research institutions are failing to submit their clinical trial results within the deadline, and sometimes even at all.
The public database created by the legislation was intended to help the public, particularly medical professionals, scientists, and other researchers, to quickly access the latest findings on human testing of drugs, medical devices, and the like.
Institutions’ failure to turn in their results, however, is directly counteracting this legislative purpose. This is particularly concerning because doctors may not be getting critical information including adverse events in drug trials.
Interviews with the offending institutions indicate that the primary reason for these deadline lapses on the institutions’ end is due to being too busy and a lack of funding. Memorial Sloan Kettering, however, specifically stating it submitted some of its reporting in order to finish medical journal articles related to its trials. On top of institution failures to submit, is clear that the NIH is compounding the issue by failing to follow up on clinical trial deadlines.
Experts interviewed by the sources have further expressed concern that pressure from sponsoring drug companies may also be part of the reason why these clinical trials are not coming to light.