Excerpt

The Institute of Medicine Roundtable on Value & Science-Driven Health Care’s vision for a learning healthcare system, in which evidence is applied and generated as a natural course of care, is premised on the development of a research capacity that is structured to provide timely and accurate evidence relevant to the clinical decisions faced by patients and providers. Convened in 2006, the Roundtable has considered key opportunities to transform how evidence is generated and applied to improve health and health care. Therefore, on December 12–13, 2007, as part of the Roundtable’s Learning Healthcare System series of workshops, clinical researchers, academics, and policy makers gathered for the workshop Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches. Participants explored cutting-edge research designs and methods and discussed strategies for development of a research paradigm to better accommodate the diverse array of emerging data resources, study designs, tools, and techniques. Presentations and discussions are summarized in this volume.

Contents

• The National Academies
• Roundtable on Value & Science-Driven Health Care
• Reviewers
• Institute of Medicine Roundtable on Value & Science-Driven Health Care Charter And Vision Statement
• Foreword
• Preface
• Summary
  • INTRODUCTION AND OVERVIEW
  • COMMON THEMES
  • INCREASING KNOWLEDGE FROM PRACTICE-BASED RESEARCH
  • PRESENTATION AND DISCUSSION SUMMARIES
  • ORGANIZING THE RESEARCH COMMUNITY FOR CHANGE
  • ISSUES FOR POSSIBLE ROUNDTABLE FOLLOW-UP
  • REFERENCES
• 1. Evidence Development for Healthcare Decisions: Improving Timeliness, Reliability, and Efficiency
  • INTRODUCTION
  • EBM AND CLINICAL EFFECTIVENESS RESEARCH
  • PERSPECTIVES ON CLINICAL EFFECTIVENESS RESEARCH
  • CLINICAL EFFECTIVENESS RESEARCH: PAST, PRESENT, AND FUTURE
  • THE PATH TO RESEARCH THAT MEETS EVIDENCE NEEDS
  • REFERENCES
• 2. Cases in Point: Learning from Experience
  • INTRODUCTION
  • HORMONE REPLACEMENT THERAPY
  • DRUG-ELUTING CORONARY STENTS
  • BARIATRIC SURGERY
  • ANTIPSYCHOTIC THERAPEUTICS
  • CANCER SCREENING
  • REFERENCES
• 3. Taking Advantage of New Tools and Techniques
  • INTRODUCTION
  • INNOVATIVE APPROACHES TO CLINICAL TRIALS
  • INNOVATIVE ANALYTIC TOOLS FOR LARGE CLINICAL AND ADMINISTRATIVE DATABASES
  • ADAPTIVE AND BAYESIAN APPROACHES TO STUDY DESIGN
  • SIMULATION AND PREDICTIVE MODELING
  • EMERGING GENOMIC INFORMATION
  • REFERENCES
• 4. Organizing and Improving Data Utility
  • INTRODUCTION
  • THE ELECTRONIC HEALTH RECORD AND CARE REENGINEERING: PERFORMANCE IMPROVEMENT REDEFINED
  • ADMINISTRATIVE DATABASES IN CLINICAL EFFECTIVENESS RESEARCH
  • CLINICAL EFFECTIVENESS RESEARCH: THE PROMISE OF REGISTRIES
  • DISTRIBUTED DATA NETWORKS
  • REFERENCES
• 5. Moving to the Next Generation of Studies
  • INTRODUCTION
  • LARGE DATA STREAMS AND THE POWER OF NUMBERS
  • OBSERVATIONAL STUDIES
  • ENHANCING THE EVIDENCE TO IMPROVE PRACTICE: EXPERIMENTAL AND HYBRID STUDIES
  • ACCOMMODATING GENETIC VARIATION AS A STANDARD FEATURE OF CLINICAL RESEARCH
  • PHASED INTRODUCTION AND PAYMENT FOR INTERVENTIONS UNDER PROTOCOL
  • RESEARCH NETWORKS
  • REFERENCES
• 6. Aligning Policy with Research Opportunities
  • INTRODUCTION
  • COURSE-OF-CARE DATA
  • PHARMACEUTICAL INDUSTRY DATA
  • REGULATORY REQUIREMENTS AND DATA GENERATION
  • ENSURING OPTIMAL USE OF DATA GENERATED BY PUBLIC INVESTMENT
  • BUILDING THE RESEARCH INFRASTRUCTURE
  • ENGAGING CONSUMERS
  • REFERENCES
• 7. Organizing the Research Community for Change
  • INTRODUCTION
  • INCREASING KNOWLEDGE FROM PRACTICE-BASED RESEARCH
  • OPPORTUNITIES FOR ACTION
  • COMMON THEMES
  • ISSUES FOR POSSIBLE ROUNDTABLE FOLLOW-UP
• Appendixes
  • Appendix A. Workshop Agenda
  • Appendix B. Biographical Sketches of Workshop Participants
  • Appendix C. Workshop Attendee List
• Other Publication in the Learning Healthcare System Series

Suggested citation:

IOM (Institute of Medicine). 2010. Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches: Workshop Summary. Washington, DC: The National Academies Press.

Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.