Half of EU Clinical Trial Results Not Reported
Despite EU requirements for clinical trials to report results to the EU Clinical Trials Register within a year of a trial’s completion, sponsors have only reported about half of them so far.
The analysis, led by University of Oxford researcher Ben Goldacre, found trial sponsors only reported about 51 percent of 7,274 clinical trial results since publication of the European Commission’s guidelines in 2014. Of these, 68 percent of trials with a commercial sponsor posted the results, while only 11 percent of non-sponsored trials shared theirs.
The study found that 32 major universities did not report results for any trials they sponsored. Eleven drugmakers whose trial data the researchers analyzed reported all the trials they sponsored, including Genentech, Gilead and Boehringer Ingelheim. On the other end of the spectrum, Eli Lilly reported only 52 percent of its trials.
“The biggest offenders of not publicly releasing clinical trial data are academic institutions,” says Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest, a nonprofit medical issues research group. “Part of the problem is academic institutions don’t feel the need to abide by the same standards pharmaceutical companies do” when it comes to reporting clinical trials data.
Another problem in reporting trial data is methodological, according to Pitts, because sponsors don’t feel obligated to release early stage data.
“Clearly what’s most important are human trials,” he says, “but oftentimes early studies aren’t released because sponsors don’t think they have any relevance.”
Independent researchers are often unable to verify and build on clinical trial findings without access to this data, but no entity has ever been penalized for failing to fulfill the reporting requirements, according to the study published in BMJ. The EU regulation calls on all trial sponsors to report results one year after a trial concludes, or within six months in the case of research involving children. Trials that miss reporting deadlines by three months or more are to be flagged by the EU, but there is no system in place to flag overdue trials.
“We need to reflect on how we can improve our communication with academic sponsors and smaller sponsor organizations. This study helps to spread the word on how important it is to post trial results once a clinical trial is over,” Fergus Sweeney, head of inspections for the EMA Human Medicines Pharmacovigilance and Committees, said. “We ... are firm believers that transparency and public availability and scrutiny of clinical trial information and results are fundamental for the protection and promotion of public health.”
Link to study here: https://www.bmj.com/content/362/bmj.k3218.