BOX 1-1
Statement of Task for the Workshop

This public workshop focused on strategies to facilitate sharing of clinical research data in order to advance scientific knowledge and public health. While the workshop focused on sharing of data from preplanned interventional studies of human subjects, models and projects involving sharing of other clinical data types were considered to the extent that they provided lessons learned and best practices. The workshop objectives were to

•   examine the benefits of sharing of clinical research data from all sectors and among these sectors, including, for example:

 — benefits to the research and development enterprise and

 — benefits to the analysis of safety and efficacy;

•   identify barriers and challenges to sharing clinical research data;

•   explore strategies to address these barriers and challenges, including identifying priority actions and “low-hanging fruit” opportunities; and

•   discuss strategies for using these potentially large datasets to facilitate scientific and public health advances.

along with issues that warrant more focused attention. These points are presented in the next section of this first chapter of the workshop summary as an introduction to the themes of the workshop. Chapter 2 of this report summarizes the benefits of sharing clinical research data and suggests why and when increased data sharing can improve both scientific knowledge and public health. Chapter 3 considers the barriers to data sharing and examines changes that could overcome those barriers. Chapter 4 describes different models of data sharing to demonstrate best practices and lessons learned from each project. Chapter 5 looks at the standardization of clinical data, for both data collected in the past and future data collection efforts. Chapter 6 contains a discussion of mechanisms and incentives to enhance data transparency and sharing across all sectors. Chapter 7 concludes this workshop summary by gathering key take-away points from the workshop that were identified by speakers and other participants as a way to highlight and elaborate on next steps for advancing the sharing of clinical trials data.



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