EMA, Regulatory

Pharma companies outperform institutions in European clinical trial reporting amid problematic overall trends — Oxford study

Half of all trials supposed to be reported in a European database are not, despite clear legal requirements, researchers have found in the first such study of compliance, which also notes that pharma companies do better in this regard than academic institutions, charities and hospitals.

Ben Goldacre

Combing through 7274 trials on the EU Clinical Trials Register (EUCTR) that have passed the due date for posting data, a team out of Oxford’s Evidence-Based Medicine DataLab noted that only 49.5% reported their results — meaning half of the time, trials sponsors have breached a 2012 European Commission guideline that mandates disclosure within 12 months of study completion.

The team — led by the high-profile Oxford research Ben Goldacre — has launched an interactive online database that they plan to update monthly in addition to posting a paper in The BMJ. The oldest trial tracked dates back to 2004.

In general, commercial sponsors are much more likely to post results; 68% of their trials are reported, compared to 11% for a non-commercial sponsor. Scale also mattered, as the bigger sponsors tied to a large number of trials collectively reported more of their trials (78%) than their smaller counterparts (18%).

Furthermore, all 11 entities recording a 100% reporting rate are pharma companies: Boehringer Ingelheim, Chiesi Farmaceutici, Almirall, Gilead, Otsuka, CSL Behring, Alcon, Vertex, Genentech, Daiichi Sankyo and Leo Pharma. Even the worst performing pharma— Pierre Fabre — reported 55% of the trials it’s supposed to.

Novartis and GlaxoSmithKline, the only two sponsors with more than 1,000 trials on the EUCTR, have reported rates of 94.7% and 92.1% respectively.

“Although poor reporting rates in some sectors is a source of concern, the extremely high rate of compliance among commercial sponsors conducting a large number of trials is positive: it shows that, with an unambiguous requirement for all trials to report results, near perfect compliance can practically be delivered,” the researchers wrote.

There’s a catch, though.

The researchers didn’t technically count all the trials that were due to report. That’s because omissions and inconsistencies in trial completion dates made it impossible to determine whether a sponsor was compliant in 3392 cases — which makes up 29.4% of all trials marked “completed” or “terminated.” And these problems show up even in trials conducted by the 100% compliant sponsors.

Source: The BMJ

It’s just as much of a problem as non-reporting to regulators — and the EMA can do a better job monitoring it while sponsors also clean up their act.

“We can’t make informed choices if the results of clinical trials are withheld from doctors, researchers, and patients,” the researchers wrote on their database, adding in the paper: “We hope that the accessible and timely information on the compliance status of each individual trial and sponsor provided by our EU.trialstracker.net will help to improve reporting rates”.


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