Across the 2 days of presentations and discussion, several common themes—listed in Box 8-1 and elaborated below—emerged as issues for particular attention in accelerating progress in the availability and use of clinical data for new insights.
Clarity on the basic principles of clinical data stewardship. The starting point for expanded access and use of clinical data for knowledge development is agreement on some of the fundamental notions to guide the activities for all individuals and organizations with responsibility for managing clinical data. Workshop participants repeatedly mentioned the need for consensus on approaches to such issues as data structure, standards, reporting requirements, quality assurance, timeliness, deidentification or security measures, access, and use procedures—all of which will determine the pace and nature of evidence development.
Incentives for real-time use of clinical data in evidence development. Current barriers to the real-time use of clinical data for new knowledge discussed at the workshop ranged from regulatory and commercial issues to cost and quality issues. Participants suggested the need for a dedicated program of activities, incentives, and strategies to improve the methods and approaches, their testing and demonstration, the cooperative decision making on
Workshop Common Themes