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Bethesda Marriott, Congressional Ballroom

5151 Pooks Hill Road

Bethesda, MD 20814

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Embedded Pragmatic Clinical Trials of Therapeutic A vs. B Interventions Workshop

Sponsored by the National Institutes of Health Common Fund

Organizing Committee: Adrian Hernandez & Richard Platt (Co-Chairs), Laura Dember, Leslie Derr, Susan Huang, Catherine Meyers, Wendy Weber and Dave Wendler


This one-day Workshop will explore challenges and strategies for planning and implementing embedded pragmatic clinical trials (PCT) that compare two or more therapeutic medical regimens. Pragmatic trials differ from traditional clinical trials, as they test interventions or practices delivered in real-world settings. If conducted within integrated health care systems, embedded PCT can leverage existing infrastructure to answer important clinical questions in a cost-effective manner. They can also bridge the critical gap between clinical evidence, practice and policy in health care delivery.

The NIH Health Care Systems Research Collaboratory, an NIH Common Fund initiative, has launched a set of PCT in partnership with several US health care systems. These trials have served as case studies for addressing challenges of pragmatic research; and the program has developed an extensive set of methods and best practices for embedded PCT. There is considerable interest, however, in expanding the interventions tested within the Collaboratory, specifically for developing additional tools and strategies that test distinct therapeutic medical interventions – A vs. B trials.

The Workshop will include a series of moderated discussions of opportunities and approaches for partnering with health care systems, and other stakeholders, to conduct embedded A vs. B trials. Ongoing A vs. B trials in the US will be presented as potential models for future studies. In view of the diversity of health care systems and delivery in the US, different design and analytic strategies for these trials will also be presented. As regulatory oversight of the clinical research enterprise is an essential component of PCT planning and implementation, the Workshop will also discuss regulatory aspects, including ethical oversight, of trials that test such interventions. The Workshop aims to inform stakeholders on progress in pragmatic A vs. B trials, and to explore strategies for expanding future research opportunities.



Congressional Ballroom, Bethesda Marriott, Pooks Hill Road

May 16, 2018, 8:00 am – 4:15 pm



8:00 am

Welcome and Introduction

David Shurtleff, PhD
Acting Director
National Center for Complementary and Integrative Health
National Institutes of Health, DHHS

Richard Hodes, MD
Director
National Institute on Aging
National Institutes of Health, DHHS

Catherine M. Meyers, MD
Director, Office of Clinical & Regulatory Affairs
National Center for Complementary and Integrative Health
National Institutes of Health, DHHS

Wendy Weber, ND, PhD, MPH
Acting Deputy Director
Branch Chief, Clinical Research Branch
Division of Extramural Research
National Center for Complementary and Integrative Health
National Institutes of Health, DHHS



8:10 am

Keynote


Michael Lauer, MD
Deputy Director for Extramural Research
National Institutes of Health, DHHS


Q&A



8:30 am
Partnering With Stakeholders to Conduct Embedded A vs. B Trials: Keys to Success

Moderator: Rich Platt, MD
Professor and Chair, Department of Population Medicine
Harvard Pilgrim Health Care Institute

Panel:

1. Stephen Friedhoff, MD
Senior Vice President, Clinical Strategy and Programs
Anthem, Inc.

2. Kenneth Sands, MD
Chief Epidemiologist and Chief Patient Safety Officer
HCA

3. Joseph Chin, MD
Deputy Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services, DHHS

Responder: Michael Lauer, MD
Deputy Director for Extramural Research
National Institutes of Health, DHHS


Q&A



9:30 am

Examples in Action: Embedded A vs. B Trials

Moderator: Beverly Green, MD, MPH
Associate Investigator
Kaiser Permanente Washington Health Research Institute and
Kaiser Permanente Washington

Panel:

1. Ryan Ferguson, DSc, MPH
Director, Massachusetts Veterans Epidemiology Research and Information Center and Cooperative Studies Program Coordinating Center
Boston University School of Public Health

2. Susan Huang, MD, MPH
Professor, Infectious Disease and Director of Epidemiology and Infection Prevention
University of California, Irvine School of Medicine

3. Michael Kappelman, MD, MPH
Professor of Pediatrics
Division of Gastroenterology
University of North Carolina School of Medicine


Q&A



10:30 am - Break



10:45 am

Maximizing the Pragmatic: Understanding Approaches to Design of Embedded A vs. B Trials

Moderator: Gregory Simon, MD, MPH
Senior Scientific Investigator
Kaiser Permanente Washington Health Research Institute
Kaiser Permanente Washington

Panel:

1. Scott Solomon, MD
Edward D. Frohlich Distinguished Chair and Professor of Medicine
Harvard Medical School
Director, Noninvasive Cardiology and Senior Physician
Brigham and Women’s Hospital

2. Rachael Fleurence, PhD
Executive Director
National Evaluation System for Health Technology Coordinating Center

3. Kourtney Davis, PhD, MSPH
Senior Director and Head
Real World Data and Analytics
GlaxoSmithKline


Q&A



11:35 am
Regulatory Aspects of Clinical Research and the Regulation of Products for Embedded A vs. B Pragmatic Trials

Moderator: Adrian Hernandez, MD
Vice Dean for Clinical Research, Duke University School of Medicine
Director, Health Services Outcomes Research
DCRI Faculty Associate
Professor of Medicine, Cardiology
Duke Clinical Research Institute

Panel:

1. Jacqueline Corrigan-Curay, JD, MD
Director, Office of Medical Policy
Center for Drug Evaluation and Research
US Food and Drug Administration, DHHS

2. Owen Faris, PhD
Director, Clinical Trials Program
Office of Device Evaluation
Center for Devices and Radiological Health
US Food and Drug Administration, DHHS

3. Julie Kaneshiro, MA
Deputy Director
Office for Human Research Protections, DHHS

Q&A



12:45 pm - Lunch



1:45 pm
Ethical and IRB Approaches for a Successful Embedded A vs. B Pragmatic Trial

Moderator: David Wendler, PhD
Senior Investigator and Head
Section on Research Ethics
Department of Bioethics
Clinical Center
National Institutes of Health, DHHS

Panel:

1. Barbara Bierer, MD
Professor of Medicine (Pediatrics)
Harvard Medical School
Senior Physician
Brigham and Women's Hospital

2. TBD

3. Judith Carrithers, JD, MPA
Director of Regulatory Services
Advarra


Q&A



3:00 pm

SUMMARY EXPERT PANEL DISCUSSION

Moderator: Catherine M. Meyers, MD
Director, Office of Clinical & Regulatory Affairs
National Center for Complementary and Integrative Health
National Institutes of Health, DHHS

Panel:

1. Adrian Hernandez, MD
Vice Dean for Clinical Research, Duke University School of Medicine
Director, Health Services Outcomes Research
DCRI Faculty Associate
Professor of Medicine, Cardiology
Duke Clinical Research Institute

2. Rich Platt, MD
Professor and Chair, Department of Population Medicine
Harvard Pilgrim Health Care Institute

3. Beverly Green, MD, MPH
Associate Investigator
Kaiser Permanente Washington Health Research Institute and
Kaiser Permanente Washington

4. Gregory Simon, MD, MPH
Senior Scientific Investigator
Kaiser Permanente Washington Health Research Institute
Kaiser Permanente Washington

5. David Wendler, PhD
Senior Investigator and Head
Section on Research Ethics
Department of Bioethics
Clinical Center
National Institutes of Health, DHHS



4:00 pm

Concluding Remarks

Adrian Hernandez, MD
Vice Dean for Clinical Research, Duke University School of Medicine
Director, Health Services Outcomes Research
DCRI Faculty Associate
Professor of Medicine, Cardiology
Duke Clinical Research Institute

Rich Platt, MD
Professor and Chair, Department of Population Medicine
Harvard Pilgrim Health Care Institute

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Bethesda Marriott, Congressional Ballroom

5151 Pooks Hill Road

Bethesda, MD 20814

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