“An ad hoc planning committee under the auspices of the National Academies of Sciences, Engineering, and Medicine, will plan and conduct a two-day public workshop to discuss advances, challenges, and opportunities in clinical trial data sharing efforts since the release of the 2015 Institute of Medicine report, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. This workshop is co-sponsored by the Wellcome Trust.
Consider the value and potential risks/costs of sharing clinical trial data for key stakeholders, including clinical trialists, sponsors, primary and secondary researchers, and patients;
Review the current landscape of clinical trial data sharing and reuse across public and private sectors (e.g. policies, platforms, collaborations, data sharing culture, published research output);
Examine use cases and trends from across public and private sectors when it comes to success, failure, lessons learned, and value;
Consider the perspectives and expectations of primary and secondary researchers, clinical trial participants, patient organizations, research sponsors (pharmaceutical companies and nonprofit organizations), journals, institutions, and federal agencies; and
Discuss next step opportunities for stakeholders to better harmonize incentives, policy, data standards, and governance to encourage the sharing and reuse of clinical trial data.
The planning committee will organize the workshop, develop the agenda, select and invite speakers and discussants, and moderate or identify moderators for the discussions. A proceedings of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines….”