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On May 6, the PACE Initiative lead a
national invitational forum of health services research experts
and policymakers to discuss new approaches to clinical trials
and implications for comparative effectiveness research.
The organizing committee included Dr. Luce, Dr. Sean Tunis of the Center for Medical Technology Policy (CMTP),
Dr. Judith Kramer of the Clinical Trials Transformation
Initiative (CTTI) and Duke Clinical Research Institute (DCRI), and Dr.
Sandy Schwartz of the University of Pennsylvania.
The event kicked of with a keynote address by Robert J. Temple, MD,
Director, Office of Drug Evaluation and
Director for Medical Policy, Food and Drug
Administration (FDA) on “The Case
for Comparative Trials in the Comparative Effectiveness Research
Agenda.”
The day included three sessions addressing practical and theoretical
challenges for comparative effectiveness concluded with a
reactor panel of senior representatives from government, payers,
providers, researchers, and manufacturers. Agenda
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Activities to date |
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- Luce BR, Caro JJ, Kim M. “Rethinking Randomized Clinical Trials for CER — The Need for Transformational Change”, presented to CBI’s 3rd Annual Evidence-Based Medicine and Comparative Effectiveness Research Summit, November 17, 2009, Philadelphia, Pennsylvania.
- Luce BR. “Organizing for and Rethinking Comparative Effectiveness Trials: The Need for Transformational Change”. Complementary and Integrative Medicine (CIM) Stakeholder Symposium, Baltimore, Maryland November 9, 2009.
- Hunter C, Luce BR, Caro JJ. “How Comparative Effectiveness Research Is Transforming Pharmaceutical and Device R&D and Promotion”. DIA Webinar, November 3, 2009.
- Inaugural Meeting, PACE Sponsor Advisory Council, September 25, 2009, Bethesda, Maryland
- Luce BR. “Barriers and Opportunities with New Methods for CMS’ Coverage with Evidence Development Policy”; Agency for Health Care Research and Quality, Annual Meeting, September 14, 2009, Rockville, Maryland.
- Luce BR “Bayesian Adaptive Trials for Comparative Effectiveness Research”, AcademyHealth Annual Research Meeting, Chicago, Illinois, June 26, 2009
- Luce BR, Caro JJ. The PACE Initiative, Need & Rationale for More Efficient Approaches to Comparative Pragmatic Trials and Their Simulation”. Presented to the National Heart Lung & Blood Institute, Rockville, Maryland, June 24, 2009
- Luce BR. Statement to CMS MEDCAC meeting on the role and benefitds of Bayesian adaptive methods for Coverage with Evidence Development, June 16, 2009
- The Comparative Effectiveness Research Wave: Solving Surfing Techniques? ISPOR Sponsored Session, May 18, 2009, Orlando, Florida
- B. Luce. Getting to “Yes” (aka: When do we know (what is the minimal threshold) when we have “just enough” evidence for a real world (read, coverage decision maker; clinical guideline committee) decision? [Presentation]
- Anirban Basu PhD, University of Chicago. Thresholds to Invest: Manufacturers’ Elasticities for Sponsoring Real World Comparative Trials (aka: “Just how much does cost, time, risk need to be decreased for a manufacturer to fund a CE trial of its product?”) [Presentation]
- David J. Vanness PhD, UBC. Building off the Existing Evidence (aka: “The world may be flat, but is the prior?”) [Presentation]
- J. Jaime Caro MDCM, FRCPC, FACP, UBC. The Role of Dynamic Predictive Simulation in Guiding the Pragmatic, Adaptive Trial [Presentation]
- New Approaches to Clinical Trials: Implications for Comparative Effectiveness (Invitational, national forum, organized by PACE), May 6, 2009, Washington, D.C.
- Luce BR. Statements about the need for pragmatic trials and novel approaches to improve efficiency to:
- Federal Coordinating Council on Comparative Effectiveness Research Public Listening Session, Washington, D.C., April 14, 2009.
- Open meeting of the National Advisory Council for the Agency for Healthcare Research and Quality (AHRQ), April 3, 2009, Rockville, Maryland.
- The Institute of Medicine (IOM) Committee public meeting for consideration of priorities for comparative effectiveness research (CER), March 20, 2009, Washington, D.C.
- PACE Advisory Board Second Meeting, February 18, 2009, Bethesda, Maryland
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