Wider access to participant-level clinical trial data, while eagerly sought by independent researchers and public health advocates, gives others pause. Participants (or would-be participants) worry about privacy. Regulators foresee additional enforcement burdens and legal challenges. And clinical trial sponsors see threats to their business interests.
Hoping to secure the benefits of greater transparency while balancing the interests of all involved, policy experts centered at Harvard have offered their recommendations for expanded access to information from clinical trials. These experts, in a paper published online October 21 in the New England Journal of Medicine, outline four regulatory scenarios for a comprehensive data-sharing system.
In general, the scenarios offer different degrees of openness. They include an open access model, a database query model, a sponsor review model, and a learned intermediary model. Each model describes different combinations of decision makers, data-release criteria, and processes for evaluating information requests.
According to the experts, whatever system is used to expand access to clinical trial data should have mechanisms to ensure that all sponsors and data users adhere to minimum standards—for example, rules should specify what must be shared, and data users should commit to following a scientifically sound analytical plan. If sponsors are permitted to influence which data requests get granted, they should be required to apply explicit decision criteria and publicly explain the reasons for denials. Using an independent intermediary organization to make those decisions, however, may be preferable.
The authors’ recommendations encompass trials of all approved prescription drugs, medical devices, and biologics. The stated goal of these recommendations it to treat all trial sponsors and qualified data requesters evenhandedly.
In the paper, the authors recognize a general trend toward more openness. “As in other areas of health care, the push for greater transparency in the area of clinical trial data appears inexorable,” they authors write. “The question is not whether, but how, these data should be broadly shared. The potential risks to research participants and trial sponsors must be thoughtfully addressed in the design of any new data-sharing system but need not block progress toward achieving the promise of ‘big data’ in the clinical trials context.”
The paper, entitled “Preparing for Responsible Sharing of Clinical Trial Data,” enjoys a timely release. It follows the June announcement by the EMA that it will provide public access to participant-level data submitted in applications for marketing approval in Europe. Also, the paper’s appearance coincides with the first meeting of the Institute of Medicine’s Committee on Strategies for Responsible Sharing of Clinical Trial Data on October 23.