Europe now publishing clinical trial reports. Will the U.S. follow suit?
Now that a European drug regulatory agency has begun disclosing detailed results of clinical trials, many in the U.S. are wondering if the FDA will follow suit.
In October the London-based European Medicines Agency (EMA) published about 100 reports (some 260,000 collective pages) offering full disclosure on the results of recent trials involving the approved cancer drug carfilzomib and approved treatment lesinurad. It now plans to release all such reports filed since January of 2015, after which time it will aim to release about 4,500 reports annually. At least initially, individual patient data and commercially proprietary info will be removed before publication, though policy details are still being negotiated in accordance with the EU’s complex data protection rules.
The initial EMA action was considered groundbreaking since the EMA was the first major drug regulatory group to offer such complete transparency regarding the reports it receives from pharmaceutical firms. Typically, much more condensed versions are published for the public in scientific journals; some consider those clinical study reports (CSRs) incomplete and believe they often lack detail about a drug’s adverse effects. In the past, the more detailed data was sometimes only available after the filing of freedom-of-information requests, since some pharma firms considered it to be commercially proprietary.
A group of some 700 medical and patient organizations have been lobbying for such disclosure via an international campaign known as “AllTrials,” whose organizers contend only half of all global clinical trial results are published. Some 89,721 people have signed a related petition calling for better disclosure.
Naysayers contend greater transparency threatens the commercial value of developing proprietary drugs and could discourage big pharma from moving forward with certain tests. Others say the tangle of patient privacy issues could be difficult to unravel.
Proponents of the EMA’s actions, however, say they’ll allow academics and drug developers to take a closer look at the study data so they can learn from others’ experiences. And many are hoping the tradition of transparency will carry over to the U.S., where the FDA isn’t obligated to release CSRs on drugs being considered for approval.
“The practice is bad for science because it means the literature is biased towards positive results, and researchers will unknowingly repeat failed experiments,” states a recent editorial on Nature.com. “It is bad for medicine because dangerous side effects stay hidden. Most of all, it is bad for the volunteers who take part in trials, risking their health only to see their contribution confined to a desk drawer.”
Many are encouraged by a U.S. Department of Health and Human Services ruling in September requiring researchers to publish trial data within a year of completion, including their exact methodology, their plans for analyzing results, and any protocol changes — whether the therapy is pending approval or not. The change also empowers the government to enforce penalties for noncompliance.
The effects of the new law, including adherence rates, should become apparent over the coming year. But some say the U.S. is long overdue to step up and shine light on all medical findings, not just the ones cherry-picked by those with a vested interest in their outcome.
“There is a huge, inevitable policy trajectory towards greater transparency throughout the whole of society and in clinical medicine,” says Dr. Ben Goldacre, founder of the AllTrials movement and a clinical research fellow at the University of Oxford. “The people who do it fastest and best will take a prize, and those leaders will be truly improving patient care, whether they’re from industry or academia.”