How should clinical trial data be shared?

The movement toward greater clinical trial transparency is rapidly gaining steam in the United States, with numerous initiatives reflecting varying perspectives about which data should be shared, how they should be shared, and who should have access to them.

The data sharing movement, playing out simultaneously in Europe and the US, is a result of several converging factors. These include a growing appreciation of the magnitude and effect of missing and misreported data in published journal articles1 and in reports to the federal repository www.clinicaltrials.gov,2 the need for combining datasets to advance science in many specialties, and the recent focus on “open data” throughout all science and technology spheres.

On one side is the view that, for society to fully benefit from the results of biomedical clinical trials, all de-identified patient level data from trials should be made available to anyone who wants to use them. But other stakeholders, citing concerns about participant privacy, intellectual property, and the potential for misuse of data, instead support various models that provide increased but not unfettered access to certain types of data.

“Overall, I would say that data sharing in the US is caught between kind of a push-pull. On one hand, there is a deep public and scientific clamoring for more information and better information. On the other hand [there] are really unsettled questions about confidentiality and who directs and controls the data,” Jennifer Geetter, a life sciences lawyer specializing in data sharing and other factors related to biomedical innovation, said in an interview.

Progress is being made on many fronts, but true consensus on best practices is likely to take some time, experts tell the BMJ.