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InterContinental San Francisco

Nov 05, 2018 7:00 AM - Nov 06, 2018 3:00 PM

888 Howard Street, San Francisco, CA 94103

Real World Evidence Conference

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Session 4: The Drive Towards Pragmatism in Randomized Clinical Trials: Are We There Yet?

Session Chair(s)

James Harnett, PharmD, MS

James Harnett, PharmD, MS

Executive Director, Health Economics and Outcomes Research

Regeneron Pharmaceuticals, Inc. , United States

Debra Schaumberg, DrSc, MPH

Debra Schaumberg, DrSc, MPH

Vice President and Global Head, Startegic Development Consulting Chair

Evidera | PPD, United States

This session will introduce pragmatic clinical trials (PCTs) and the dimensions of pragmatism for consideration in the design of randomized clinical trials and as a bridge to real world evidence generation. Speakers will cover how to build fit-for-purpose evidence to inform decisions by regulators, payers, providers, and patients. Examples of PCTs that have supported regulatory decisions will be shared and considerations for future regulatory guidance for RWE will be discussed

Learning Objective : At the conclusion of this session, participants should be able to:
Describe the dimensions of pragmatism that can be considered in designing randomized clinical trials
Discuss relevant examples of PCTs to support healthcare decision-making
Identify challenges with PCTs and opportunities to address

Speaker(s)

Mark J Cziraky, PharmD

Getting to Value

Mark J Cziraky, PharmD

Anthem HealthCore, United States

Vice President of Research

Frank W. Rockhold, PhD, MSc

The Drive Towards Pragmatism in Randomized Clinical Trials: Are We There Yet?

Frank W. Rockhold, PhD, MSc

Duke Clinical Research Institute, Duke University Medical Center, United States

Professor of Biostatistics

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