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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12197.
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Appendix A
Workshop Agenda

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.

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12197.
×

DAY ONE

8:30

WELCOME AND OPENING REMARKS

Denis A. Cortese, Mayo Clinic and Chair, IOM Roundtable on Evidence-Based Medicine

9:00

KEYNOTE: CLINICAL EFFECTIVENESS RESEARCH—PAST, PRESENT, AND FUTURE

Overview of the evolution of clinical effectiveness research, current state of play, key challenges (e.g., keeping pace, inference gap, cost, policy), and future opportunities to generate reliable insights.

Harvey V. Fineberg, Institute of Medicine

9:30

SESSION 1: CASES IN POINT—LEARNING FROM EXPERIENCE

This session will present several case examples of high profile issues—some linked to delayed applications of effective treatments or to premature adoption of unwarranted treatments—that hold important lessons for future work in the design and interpretation of clinical effectiveness studies.

Chair: Joel Kupersmith, Veterans Health Administration and IOM Roundtable on Evidence-Based Medicine

 

Hormone replacement therapy

 

JoAnn E. Manson, Harvard Medical School

 

Drug-eluting coronary stents

 

Ashley B. Boam, Food and Drug Administration

 

Bariatric surgery

 

David R. Flum, University of Washington

[10:15 to 10:30 Break]

 

Antipsychotic therapeutics

 

Philip S. Wang, National Institute of Mental Health

 

Cancer screening

 

Peter B. Bach, Memorial Sloan-Kettering Cancer Center Respondent: Brian G. Firth, Cordis

 

General discussion

12:00

LUNCH

(Box lunches are available in the Executive Dining Room)

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12197.
×

12:45

SESSION 2: TAKING ADVANTAGE OF NEW TOOLS AND TECHNIQUES

Where might we expect improvements from analytic tools, sample size, and data quality and availability? What novel techniques could researchers use in conjunction with new information, models, and tools?

Chair: Donald M. Steinwachs, Johns Hopkins University and IOM Roundtable on Evidence-Based Medicine

 

Innovative approaches to clinical trials

 

Robert M. Califf, Duke University

 

Innovative analytic tools for large clinical and administrative databases

 

Sebastian Schneeweiss, Harvard Medical School

 

Adaptive and Bayesian approaches to study design

 

Donald A. Berry, University of Texas, M.D. Anderson Cancer Center

 

• Simulation and predictive modeling

 

Mark S. Roberts, University of Pittsburgh, Archimedes Inc.

 

Emerging genetic information

 

Teri A. Manolio, National Human Genome Research Institute

 

Respondent: Michael Lauer, National Heart, Lung, and Blood Institute

General discussion

[2:45 to 3:00 Break]

3:00

SESSION 3: ORGANIZING AND IMPROVING DATA UTILITY

What are the research implications of the development of much larger, electronically accessible health records and administrative and clinical databases? How might they most appropriately be applied to clinical effectiveness research? What rules of engagement are needed to harness emerging data sources?

Chair: Denis A. Cortese, Mayo Clinic and IOM Roundtable on Evidence-Based Medicine

 

Electronic health records/point of care data

 

Ronald A. Paulus, Geisinger Health System

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12197.
×

 

Administrative and claims data

 

Alexander M. Walker, Harvard School of Public Health & Worldwide Health Info. Science Consultants

 

Registries

 

Alan J. Moskowitz, Columbia University

 

Distributed research model

 

Richard Platt, Harvard Pilgrim Health Care and Harvard Medical School

 

Respondent: William H. Crown, Ingenix

General discussion

4:45

GENERAL DISCUSSION OF THE KEY POINTS OF THE DAY

Chair: Denis A. Cortese, Mayo Clinic and IOM Roundtable on Evidence-Based Medicine

5:15

RECEPTION—GREAT HALL

DAY TWO

8:45

WELCOME AND SHORT RECAP OF DAY ONE

J. Michael McGinnis, Institute of Medicine

9:00

KEYNOTE: RESEARCH THAT MEETS EVIDENCE NEEDS

Evidence gaps and research challenges. Insights on how the approach to clinical effectiveness research can better take advantage of emerging tools and study designs to address the challenges, including those related to generalizability, heterogeneity of treatment effects, and multiple co-morbidities?

Chair: Carolyn M. Clancy, Agency for Healthcare Research and Quality and IOM Roundtable on Evidence-Based Medicine

9:30

SESSION 4: MOVING TO THE NEXT GENERATION OF STUDIES

What are the key opportunities and needed advancements to improve our approach to clinical effectiveness research? How might we take better advantage of emerging resources to plan, develop, and sequence studies that are more timely, relevant, efficient, and generalizable—and account for lifecycle variation of the conditions and interventions in play?

Chair: Robert M. Califf, Duke University

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12197.
×

 

• Large data streams and the power of numbers

 

Sharon-Lise T. Normand, Harvard Medical School

 

• Observational studies

 

Wayne A. Ray, Vanderbilt University

 

• Experimental and hybrid studies

 

A. John Rush, University of Texas Southwestern Medical Center

[10:15 to 10:30 Break]

 

• Accommodating genetic variation as a standard feature of clinical research

 

Isaac S. Kohane, Harvard Medical School

 

• Phased introduction and payment for interventions under protocol

 

Wade M. Aubry, Center for Medical Technology Policy

 

• Research networks

 

Eric B. Larson, Group Health Cooperative

 

Respondent: Joe V. Selby, Kaiser Permanente

General discussion

12:00

LUNCH

(Box lunches are available in the Executive Dining Room)

12:45

SESSION 5: ALIGNING POLICY WITH RESEARCH OPPORTUNITIES

What policy levers can drive innovative research and progress in practice-based approaches? What barriers need to be addressed to accelerate the progress?

Chair: Richard Platt, Harvard Pilgrim Health Care and IOM Roundtable on Evidence-Based Medicine

 

• Course-of-care data

 

Greg Pawlson, National Committee for Quality Assurance

 

• Manufacturer data

 

Peter K. Honig, Merck

 

• Regulatory requirements and data generation

 

Mark B. McClellan, Brookings Institution

 

• Publicly sponsored health data

 

J. Sanford Schwartz, University of Pennsylvania

 

• Building the research infrastructure

 

Alan M. Krensky, National Institutes of Health

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12197.
×

 

• Engaging consumers

 

Kathy Hudson, Johns Hopkins University

 

Respondent: Jerry Avorn, Harvard Medical School

General discussion

3:15

SESSION 6: ORGANIZING THE RESEARCH COMMUNITY FOR CHANGE—DISCUSSION PANEL

What guiding principles are important in refining the clinical effectiveness research paradigm and in fostering the necessary changes? What issues need to be addressed in integrating trials into a lifecycle approach to evidence development? What expertise and training might be needed? What are some of the political challenges?

Chair: J. Michael McGinnis, Institute of Medicine

 

Panel discussion

Panel: Alan M. Krensky (NIH), Mark B. McClellan (Brookings Institution), Garry Neil (Johnson & Johnson), John Niederhuber (NCI), Lewis Sandy (United HealthCare)

4:30

CONCLUDING SUMMARY REMARKS AND ADJOURNMENT

J. Michael McGinnis, Institute of Medicine

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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12197.
×
Page 381
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12197.
×
Page 382
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12197.
×
Page 383
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12197.
×
Page 384
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12197.
×
Page 385
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12197.
×
Page 386
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Recent scientific and technological advances have accelerated our understanding of the causes of disease development and progression, and resulted in innovative treatments and therapies. Ongoing work to elucidate the effects of individual genetic variation on patient outcomes suggests the rapid pace of discovery in the biomedical sciences will only accelerate. However, these advances belie an important and increasing shortfall between the expansion in therapy and treatment options and knowledge about how these interventions might be applied appropriately to individual patients. The impressive gains made in Americans' health over the past decades provide only a preview of what might be possible when data on treatment effects and patient outcomes are systematically captured and used to evaluate their effectiveness. Needed for progress are advances as dramatic as those experienced in biomedicine in our approach to assessing clinical effectiveness.

In the emerging era of tailored treatments and rapidly evolving practice, ensuring the translation of scientific discovery into improved health outcomes requires a new approach to clinical evaluation. A paradigm that supports a continual learning process about what works best for individual patients will not only take advantage of the rigor of trials, but also incorporate other methods that might bring insights relevant to clinical care and endeavor to match the right method to the question at hand.

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. 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.

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