Sharing data from clinical trials: where we are and what lies ahead

Almost a decade ago an Italian scientist, Alessandro Liberati, wrote an impassioned Personal View in the BMJ. He had developed myeloma and needed to decide whether to have a second bone marrow transplant. Among the evidence pertinent to his decision were “four randomised controlled trials, whose results haven’t yet been fully published . . .” “Why,” he asked, “was I forced to make my decision knowing that information was somewhere but not available?” He concluded that “Research results should be easily accessible to people who need to make decisions about their own health.”1 His story put a human face on the harm that can occur when clinical research data are not available.

In 2003 the US National Institutes of Health (NIH) published a final statement on sharing of data from research activities it had funded. The statement reaffirmed support for the concept of data sharing, which NIH said was “essential for expedited translation of research results into knowledge, products, and procedures to improve human health.” Henceforth, NIH announced, investigators seeking NIH grants over $500 000 (£325 000; €377 000) or more would be “expected to include a plan for data sharing or state why data sharing is not possible.”2

It is difficult to identify exactly when the crusade began for better access to clinical trial data, but this action by NIH was certainly among the opening salvos in the struggle. Over the past decade, the movement for clinical trial data transparency has become global in scope, with European regulators, health research funders, and international coalitions of scientists taking a prominent role. Proponents …