8:30Welcome and Opening Remarks

Harvey Fineberg, Institute of Medicine

Darrell Kirch, Association of American Medical Colleges
What would be the features of a healthcare system designed not to learn—how might it be corrected?
9:00Session 1: Hints of a Different Way—Learning from Experience Case Studies in Practice-Based Evidence Development

Chair: Carolyn Clancy, Agency for Healthcare Research and Quality (AHRQ) and EBM Roundtable Member
What “best practices” might be spotlighted to illustrate ways to use the health care experience as a practical means of both generating and applying evidence for health care? Are there lessons from certain examples that can help identify the most promising approaches?
15-minute presentations followed by discussion session
 Peter Bach, Centers for Medicare & Medicaid Services (CMS)
  Coverage with evidence development: Lung volume reduction surgery
 Jed Weissberg, Permanente Federation
  Use of large system databases: Cyclooxygenase-2 (COX-2) inhibitors
 Stephen Soumerai, Harvard Pilgrim Health Care
  Potential of quasi-experimental designs for evaluating health policy
 Sean Tunis, Health Technology Center
  Practical clinical trials
 Alan Morris, Latter Day Saints Hospital and University of Utah
  Computerized protocols to assist clinical research*
10:30Session 2: The Evolving Evidence Base—Methodologic and Policy Challenges

Chair: Don Steinwachs, Johns Hopkins University and EBM Roundtable Member
What challenges confront methodologically rigorous learning from experience? How can alternatives to randomized controlled trials (RCTs) and innovative approaches to generating evidence be used to confront emerging challenges: broader post-marketing surveillance; linking Phase III and coverage requirements; increasingly complex patterns of comorbidity; subgroup analysis, and heterogeneity in treatment outcomes? How might learning that is more nimble also foster innovation and discovery?
15-minute presentations followed by discussion session
 Robert Califf, Duke Clinical Research Institute
  Alternatives to large RCTs
 David Goldstein, Duke Institute for Genome Sciences and Policy
  Engaging the implications of subgroup heterogeneity— prospects for pharmacogenetics
 Harlan Weisman, Johnson & Johnson
  Broader post-marketing surveillance for insights on risk and effectiveness
 Telba Irony, Food and Drug Administration (FDA)
  Evaluating interventions in a rapid state of flux
 David Eddy, Archimedes Inc.
  Mathematical models to fill the gaps in evidence*
 Sheldon Greenfield, University of California at Irvine
  Heterogeneity of treatment effects: subgroup analysis*
 Steve Teutsch, Merck & Co. Inc.
  Adjusting evidence generation to the scale of effects*
 Janlori Goldman, Health Privacy Project
  Protecting privacy while linking patient records*
1:00Session 3: Narrowing the Research-Practice Divide—System Considerations

Chair: Cato Laurencin, University of Virginia and EBM Roundtable Member
What system changes are needed for the healthcare delivery environment to facilitate the generation and application of better evidence? What are the needs and implications for structuring “built-in” study designs, managing the data burden, and defining appropriate levels of evidence needed? What is needed to turn clinical data into an “epidemiologic utility,” a public good?
15-minute presentations followed by discussion session
 Brent James, Intermountain Healthcare
  Feedback loops to expedite study timeliness and relevance
 Walter Stewart, Geisinger Health System
  Clinical data system structure and management for better learning
 Steven Pearson, America’s Health Insurance Plans
  Implications for standards of evidence
 Robert Galvin, General Electric
  Implications for innovation acceleration
2:30Session 4: Panel Discussion—Key Barriers and Priorities for Action
Chair: Denis Cortese, Mayo Clinic and EBM Roundtable Member
Members of the Roundtable on Evidence-Based Medicine

Presentation included in workshop materials, but not delivered.

Presentation included in workshop materials, but not delivered.

From: Appendix A, Workshop Agenda

Cover of The Learning Healthcare System
The Learning Healthcare System: Workshop Summary.
Institute of Medicine (US) Roundtable on Evidence-Based Medicine; Olsen LA, Aisner D, McGinnis JM, editors.
Washington (DC): National Academies Press (US); 2007.
Copyright © 2007, National Academy of Sciences.

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