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NIH ePCT Training Workshop: Supporting Embedded Pragmatic Clinical Trials

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Natcher Conference Center

Building 45, Natcher Building

Bethesda, MD 20894

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This one-day workshop will explore challenges and strategies for designing and implementing PCT and present lessons learned.

About this Event

Pragmatic clinical trials (PCT) are distinct from more traditional clinical trials, as they are designed to assess the impact of interventions delivered in usual or real-world conditions. Moreover, performing PCT within fully integrated health care systems facilitates large-scale, cost-effective trials that leverage existing infrastructure to answer important clinical questions. PCT can also bridge the critical gap between clinical evidence, practice, and policy in health care systems.

The NIH Common Fund and several NIH Institutes, Centers, and Offices (ICOs) have been supporting the NIH Health Care Systems Research Collaboratory, which has successfully conducted many PCT in partnership with a variety of U.S. health care systems. This one-day workshop will explore challenges and strategies for designing and implementing PCT and present lessons learned from a growing NIH portfolio of PCT. The workshop presentations will focus on NIH scientists who provide oversight for such NIH-funded work, including review, program, and biostatistical staff across the NIH ICOs.

Welcome and Introductions

Helene Langevin, MD

Director

National Center for Complementary and Integrative Health

National Institutes of Health, DHHS

Catherine M. Meyers, MD

Director, Office of Clinical and Regulatory Affairs

National Center for Complementary and Integrative Health

National Institutes of Health, DHHS

Wendy Weber, ND, PhD, MPH

Chief, Clinical Research Branch

Division of Extramural Research

National Center for Complementary and Integrative Health

National Institutes of Health, DHHS

KEYNOTE – Clinical Trials in the Real World – Why NIH and Why Now

David Chambers, DPhil

Deputy Director for Implementation Science

Division of Cancer Control and Population Sciences

National Cancer Institute

National Institutes of Health, DHHS

Q&A

Panel: Examples of PCTs Supported Across NIH

Marcel Salive, MD, MPH

Medical Officer

Division of Geriatrics and Gerontology

National Institute on Aging

National Institutes of Health, DHHS

Jane Pearson, PhD

Special Advisor to the Director on Suicide Research

National Institute of Mental Health

National Institutes of Health, DHHS

Clayton Huntley, PhD

Program Officer

Basic Sciences Section

National Institute of Allergy and Infectious Diseases

National Institutes of Health, DHHS

Q&A

Engaging Stakeholders and Aligning with Health System Partners

Kevin Weinfurt

Professor and Vice Chair for Research

Department of Population Health Sciences

Duke University School of Medicine

Q&A

10:30 am

Break

ePCT Design and Analysis

David Murray, PhD

Associate Director for Prevention

Director, Office of Disease Prevention

Division of Program Coordination, Planning, and Strategic Initiatives

Office of the Director

National Institutes of Health, DHHS

Q&A

Lunch

Developing ePCT Funding Opportunities and Providing Guidance to Investigators

Wendy Weber, ND, PhD, MPH

Chief, Clinical Research Branch

Division of Extramural Research

National Center for Complementary and Integrative Health

National Institutes of Health, DHHS

Q&A

Organizing Grant Reviews for PCs: Special Considerations

Martina Schmidt, PhD

Chief, Office of Scientific Review

National Center for Complementary and Integrative Health

National Institutes of Health, DHHS

Q&A

NIH Oversight of ePCTs

Catherine M. Meyers, MD

Director, Office of Clinical and Regulatory Affairs

National Center for Complementary and Integrative Health

National Institutes of Health, DHHS

Q&A

Break

Dissemination and Implementation

Wynne Norton, PhD

Program Director

Division of Cancer Control and Population Sciences

National Cancer Institute

National Institutes of Health, DHHS

Q&A

ePCTs in Context: Panel Discussion with Program and Review Officers

Clayton Huntley, PhD

Program Officer

Basic Sciences Section

National Institute of Allergy and Infectious Diseases

National Institutes of Health, DHHS

Jane Pearson, PhD

Special Advisor to the Director on Suicide Research

National Institute of Mental Health

National Institutes of Health, DHHS

Marcel Salive, MD, MPH

Medical Officer

Division of Geriatrics and Gerontology

National Institute on Aging

National Institutes of Health, DHHS

Martina Schmidt, PhD

Chief, Office of Scientific Review

National Center for Complementary and Integrative Health

National Institutes of Health, DHHS

Wendy Weber, ND, PhD, MPH

Chief, Clinical Research Branch

Division of Extramural Research

National Center for Complementary and Integrative Health

National Institutes of Health, DHHS

Q&A

Closing Comments

Catherine M. Meyers, MD

Director, Office of Clinical and Regulatory Affairs

National Center for Complementary and Integrative Health

National Institutes of Health, DHHS

Wendy Weber, ND, PhD, MPH

Chief, Clinical Research Branch

Division of Extramural Research

National Center for Complementary and Integrative Health

National Institutes of Health, DHHS

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Natcher Conference Center

Building 45, Natcher Building

Bethesda, MD 20894

View Map

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