The Roundtable has defined evidence-based medicine (EBM) broadly to mean that, “to the greatest extent possible, the decisions that shape the health and health care of Americans—by patients, providers, payers, and policy makers alike—will be grounded on a reliable evidence base, will account appropriately for individual variation in patient needs, and will support the generation of new insights on clinical effectiveness.” This definition embraces and emphasizes the dynamic nature of the evidence base and the research process, noting not only the importance of ensuring that clinical decisions are based on the best evidence for a given patient, but that the care experience be reliably captured to generate new evidence.

The need to find new approaches to accelerate the development of clinical evidence and to improve its applicability drove discussion at the Roundtable’s workshop on December 12–13, 2007, Redesigning the Clinical Effectiveness Research Paradigm. The issues motivating the meeting’s discussions are noted in Box 1-1, the first of which is the need for a deeper and broader evidence base for improved clinical decision making. But also important are the needs to improve the efficiency and applicability of the process. Underscoring the timeliness of the discussion is recognition of the challenges presented by the expense, time, and limited generalizability of current approaches, as well as of the opportunities presented by innovative research approaches and broader use of electronic health records that make clinical data more accessible. The overall goal of the meeting was to explore these issues, identify potential approaches, and discuss possible strategies

BOX 1-1

Issues Motivating the Discussion

  • Need for substantially improved understanding of the comparative clinical effectiveness of healthcare interventions.

  • Strengths of the randomized controlled trial muted by constraints in time, cost, and limited applicability.

  • Opportunities presented by the size and expansion of potentially interoperable administrative and clinical datasets.

  • Opportunities presented by innovative study designs and statistical tools.

  • Need for innovative approaches leading to a more practical and reliable clinical research paradigm.

  • Need to build a system in which clinical effectiveness research is a more natural by-product of the care process.

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