Drugmakers are getting better at reporting clinical trials results in a timely manner, with only 10 percent of studies on new treatments approved by the European Medicines Agency in 2012 not disclosed within 12 months, a new study shows.
The study, commissioned by the Association of British Pharmaceutical Industries, looked at 340 trials associated with 23 medicines approved by the EMA in 2012. Of those, 307 — or 90 percent — had been published either in a journal or on a clinical trials registry within 12 months of trial completion or of regulatory approval by the FDA or EMA. A further five trials had published results by the end of July of last year, bringing the total to 92 percent.
Surveys of medicines approved by the EMA show that reporting rates have been slowly rising, the authors say. While just 71 percent of trials met the deadline in 2009, 81 percent did so in 2010 and 86 percent met the mark in 2011.
Sponsors have 12 months from the time of trial completion to report results, ABPI spokeswoman Karen Borrer said. That means that while some trials may have wrapped up at the time the drug received U.S. or European approval, and thus were required to report results earlier, others were still ongoing and results could have been withheld until last year.
Phase III trials had the highest reporting rates: 96 percent were disclosed within 12 months of approval and 97 percent by July 31, 2014.
The fact that smaller, earlier-phase trials had lower disclosure rates is not surprising, the study’s authors say, as many of those trials predate reporting requirements or creation of registries such as clinicaltrials.gov and EudraCT.
While the authors declined to comment on what might be behind this trend, the study hints that laws such as the EU’s Clinical Trials Regulation and draft policies and recommendations from the National Institutes of Health and the World Health Organization may be prompting sponsors to double their efforts at improving transparency.
They also note that many of the 18 marketing authorization holders from 2012 had staff responsible for ensuring that the company fulfilled its transparency commitments.
This kind of regulatory environment likely has had an effect on trial data-sharing, says Trudo Lemmens, with the University of Toronto law school in Ontario, Canada. Registries like the recent WHO International Clinical Trial Registry Platform are putting pressure on sponsors by allowing the public to see registered trials and ask for results.
But while this trend is positive, Lemmens says it shouldn’t be seen as an indication that formal regulatory requirements obligating sponsors to share trial data aren’t needed.
The study was published in an issue of Current Medical Research and Opinion. Read it at www.fdanews.com/05-07-15-ABPIreport.pdf. — Lena Freund