Sharing your thoughts about sharing clinical trial data.

The Institute of Medicine (IOM) is looking for your opinion on sharing clinical trial data. The IOM has convened an ad hoc committee to conduct a consensus study to develop recommendations for sharing clinical trial data. This committee, chaired by Bernard Lo, executive director of the Greenwall Foundation, came together in October 2013 and will deliver a final report by December 2014. As an early step, the committee created a framework for discussion that describes the committee’s early thoughts on guiding principles, defines key elements of data and data-sharing activities, and describes a select set of data-sharing activities. This framework is meant to set the stage for the identification of the numerous opportunities and challenges for which clinical data sharing may need to account. True clinical data sharing will require a culture shift, and, as such, potential effects on the broad ecosystem of biomedical research and the development of interventions must be assessed. It is often remarked that incentives are not aligned for deep collaboration and sharing, and so these must be considered across various stakeholder groups. Thus, guiding principles are not objective statements in a vacuum and could be perceived different ways by different stakeholders. Clinical trials are critical to evaluating interventions, and they are a significant investment on the part of many stakeholders: the participants in the trials, investigators who conduct the trials and analyze the data, and the sponsors of the trials. An IOM October 2012 workshop, chaired by this author, concluded that sharing clinical trial data has fairly wide acceptance as an important activity to accelerate treatment development. The workshop also concluded that much of the data generated by clinical trials is not shared, and sharing data is often difficult. An IOM workshop is an excellent vehicle for hearing from many stakeholders and defining an issue. It does not, however, make recommendations. The IOM process for creating recommendation is much more rigorous. This requires a consensus study, which in this case will recommend guiding principles and a framework, including strategies and activities, for the responsible sharing of clinical trial data. A final report will be released in December 2014. The framework document released in January 2014 did not include any recommendations, as will the final report, but instead laid out key issues so ‘‘that the public can point out omissions and begin to suggest benefits, interests, risks, and burdens of options that should be considered’’ (Institute of Medicine 2014). The committee’s charge includes articulating guiding principles and describing a selected set of data and datasharing activities. This must include the types of data that might be shared (from summary-level to individual-level data), the provider and the recipient of the data, and what kind of sharing (open, closed, semi-restricted, gate-kept, privately exchanged). The committee would like your thoughts about the following principles, strategies, and activities. Share with us what resonates, what is missing, what you disagree with, and what implications or ramifications you see. Do you know good data-sharing models? Have you experienced data sharing that led to problems? If so, what were they, and how could the challenges have been better addressed? Your contributions will help the committee refine this conceptual framework to organize the ongoing work of the committee; guide future analysis of benefits, risks, burdens, and challenges; and help shape the recommendations in final report.