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Operationalizing the Pragmatic Clinical Trial: The Role of PCORI and the Pharmaceutical Industry
Session Chair(s)
Bryan R. Luce, PhD, MBA
Chief Science Officer
Patient-Centered Outcomes Research Institute (PCORI), United States
This session will address the role that pragmatic clinical trials can play in informing health care decision-making. It will deal with design issues, opportunities (and challenges) to integrate PCTs in a learning health care system context and will draw from one example being planned by the Patient-Centered Research Institute’s (PCORI) PCORnet and another executed by a pharmaceutical company. The session will end with a description of the platform response-adaptive trial design which is a novel approach that embeds the PCT concept into the routine care of a health care system.
Learning Objective : Explain PCORI’s pragmatic clinical trial research program including how it intersects with PCORnet and the PCORI national research data network; Describe the response-adaptive platform trial concept including its application to a research-focused learning health care system; Recognize the opportunities and challenges of an industry-sponsored pragmatic clinical trial.
Speaker(s)
The PCT in PCORnet: The Aspirin Demonstration Trial
Rachael Fleurence, PhD
Patient-Centered Outcomes Research Institute (PCORI), United States
Program Director, CER Methods and Infrastructure
The Role of the Pragmatic Trial in Industry: The Salford Lung Study Example
Frank W. Rockhold, PhD, MSc
Duke Clinical Research Institute, Duke University Medical Center, United States
Professor of Biostatistics
Incorporating the PCT Into the Learning Health Care System: The Platform Response-Adaptive Trial
Jason Connor, PhD
Berry Consultants, United States
Statistical Scientist
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