Dr. Tenenbaum Speaks at the Institute of Medicine’s Sharing Clinical Research Data Workshop – Proposes Rapid Learning Inititative to Jump-Start Data Sharing in Cancer

Dr. Tenenbaum speaks at the Institute of Medicine’s Sharing Clinical Research Data:  An Institute of Medicine Workshop, October 4-5, 2012 at the National Academy of Sciences Building in Washington DC

Pharmaceutical companies, academic institutions, advocacy organizations, and government agencies such as FDA and NIH have large quantities of clinical research data. Increased data sharing could facilitate scientific and public health advances, among other potential benefits to patients and society. Much of this information, however, is not transparent or shared beyond the data owner. More specifically, study results are not always published and where results are published, they typically only include summary-level data; participant-level data is privately held and rarely shared or revealed publicly.
This workshop will explore the benefits of and barriers to the sharing of clinical research data and will help identify strategies for enhancing sharing both within and across sectors. To facilitate identification of key issues and potential solutions, the workshop will focus on data resulting from preplanned interventional studies of human subjects. While recognizing the importance of other data sources such as observational studies and electronic health records, this focus was selected to encourage concrete problem-solving discussions over the course of a day-and-a-half meeting. Models and projects that involve sharing other types of data will be considered during the workshop to the extent that these models provide lessons and best practices applicable to sharing preplanned interventional clinical research data.

The workshop is being jointly organized by the Institute of Medicine’s Forum on Drug Discovery, Development, and Translation; Forum on Neuroscience and Nervous System Disorders; National Cancer Policy Forum; and Roundtable on Translating Genomic-Based Research for Health.

Meeting Objectives:

  • Examine the benefits of sharing of clinical research data, and specifically clinical trial data, from all sectors and among these sectors, including, for example:
  • Benefits to the research and development enterprise
  • 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
  • Discuss strategies for using these potentially large data sets to facilitate scientific and public
  • health advances.October 4-5, 2012 at the National Academy of Sciences in Washington, DC.

Additional information can be found at the Institute of Medicine’s Website