According to a STAT analysis of the federal ClinicalTrials.gov database, universities and other nonprofit research centers have sharply increased reporting of clinical trial results, improving compliance to a 10-year-old federal law.
Major research universities increased their reporting averages from 58 percent in 2015 to 77 percent, as of September 2017. Memorial Sloan Kettering Cancer Center made some of the most significant improvements, from reporting 20 percent of its required results just two years ago, to 98 percent. Paul Sabbatini, MD, one of Memorial Sloan Kettering’s top clinical research executives, credited the improvement to the addition of two dedicated reporting specialists after STAT’s 2015 coverage of his institution’s poor record.
Overall, trial sponsors disclosed 72 percent of required results in 2017, compared with 58 percent in 2015.
Patients and doctors use ClinicalTrials.gov – which is run by the National Institutes of Health (NIH) – to find trials, compare the effectiveness of approved and experimental drugs and devices, and survey potentially fatal side effects.
The legal requirement to submit results began in 2008. It stemmed from many cases in which companies allegedly hid negative clinical evidence about highly profitable drugs.
The law gives the NIH and the U.S. Food and Drug Administration authority to levy financial penalties — withholding grants, or in the case of drug companies, imposing fines of up to $10,000 a day for late results. Two years ago, the agencies stated that they had not penalized violators of the ClinicalTrials.gov reporting provisions because no final rule was in place.
That final rule has now been adopted, but it retroactively forgives any violation prior to its reporting requirements going into full force on January 18, 2018.
Source: STAT News, January 9, 2018.