Appendix AWorkshop Agenda

Publication Details

Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches

A Learning Healthcare System Workshop

IOM Roundtable on Evidence-Based Medicine

December 12–13, 2007

Lecture Room

The National Academy of Sciences Building

2100 C Street, NW

Washington, DC 20037

Issues motivating the discussion

  1. Need for substantially improved understanding of the comparative clinical effectiveness of healthcare interventions.
  2. Strengths of the randomized controlled trial muted by constraints in time, cost, and limited applicability.
  3. Opportunities presented by the size and expansion of potentially interoperable administrative and clinical datasets.
  4. Opportunities presented by innovative study designs and statistical tools.
  5. Need for innovative approaches leading to a more practical and reliable clinical research paradigm.
  6. Need to build a system in which clinical effectiveness research is a more natural by-product of the care process.

Goal: To explore these issues, identify potential approaches, and discuss possible strategies for their engagement.




Hormone replacement therapy JoAnn E. Manson, Harvard Medical School




Large data streams and the power of numbers Sharon-Lise T. Normand, Harvard Medical School

Workshop Planning Committee

Robert M. Califf, MD, Duke Clinical Research Institute, Duke University

Lynn Etheredge, George Washington University

Kim Gilchrist, MD, AstraZeneca LP

Bryan Luce, PhD, MBA, United Biosource Corporation

Jonathan Perlin, MD, PhD, MSHA, FACP, HCA Inc.

Richard Platt, MD, MS, Harvard Medical School and Harvard Pilgrim