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Living Textbook of
Pragmatic Clinical Trials

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Rethinking Clinical Trials

A Living Textbook of Pragmatic Clinical Trials

  • Design
    • What is a Pragmatic Clinical Trial?
    • Decentralized Pragmatic Clinical Trials
    • Developing a Compelling Grant Application
    • Experimental Designs and Randomization Schemes
    • Endpoints and Outcomes
    • Analysis Plan
    • Using Electronic Health Record Data
    • Building Partnerships and Teams to Ensure a Successful Trial
    • Intervention Delivery and Complexity
    • Patient Engagement
  • Data, Tools & Conduct
    • Assessing Feasibility
    • Acquiring Real-World Data
    • Assessing Fitness-for-Use of Real-World Data
    • Study Startup
    • Participant Recruitment
    • Monitoring Intervention Fidelity and Adaptations
    • Patient-Reported Outcomes
    • Clinical Decision Support
    • Mobile Health
    • Electronic Health Records–Based Phenotyping
    • Navigating the Unknown
  • Dissemination & Implementation
    • Data Sharing and Embedded Research
    • Dissemination Approaches for Different Audiences
    • Implementation
    • End-of-Trial Decision-Making
  • Ethics & Regulatory
    • Privacy Considerations
    • Identifying Those Engaged in Research
    • Collateral Findings
    • Consent, Disclosure, and Non-Disclosure
    • Data and Safety Monitoring
    • Ethical Considerations of Data Sharing in Pragmatic Clinical Trials
    • Ethics for AI and ML
    • IRB Responsibilities and Procedures
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  • October 2019

  • Fri 11

    Grand Rounds October 11: Objecting to Experiments that Compare Two Unobjectionable Policies or Treatments: Implications for Comparative Effectiveness and Other Pragmatic Clinical Trials

    October 11, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Michelle N. Meyer, PhD, JD Assistant Professor & Associate Director, Research Ethics Center for Translational Bioethics & Health Care Policy Faculty Co-Director, Behavioral Insights Team Steele Institute for Health […]

  • Fri 18

    Grand Rounds October 18: Playing with FHIR–Innovative Use Cases for the New REDCap EHR Integration Module

    October 18, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Paul A. Harris, PhD Director, Professor of Biomedical Informatics Vanderbilt University Medical Center Topic: Playing with FHIR–Innovative Use Cases for the New REDCap EHR Integration Module Date: Friday, October 18, 2019, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go […]

  • Fri 25

    Grand Rounds October 25: Real-World Evidence for Drug Effectiveness Evaluation: Addressing the Credibility Gap

    October 25, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Richard Willke, PhD Chief Science Officer, ISPOR Topic: Real-World Evidence for Drug Effectiveness Evaluation: Addressing the Credibility Gap Date: Friday, October 25, 2019, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php. To join the online meeting: Go […]

  • November 2019

  • Fri 1

    Grand Rounds November 1: NIH Collaboratory: Looking Back and Looking Forward

    November 1, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Adrian F. Hernandez, MD, MHS Professor of Medicine Vice Dean for Clinical Research Duke University, School of Medicine Lesley H. Curtis, PhD Chair and Professor Department of Population Health Sciences Duke University School of Medicine Interim Executive Director, Duke Clinical Research Institute Kevin Weinfurt, PhD Professor and Vice Chair of Research Department of Population […]

  • Fri 8

    Grand Rounds November 8: Lumbar Imaging with Reporting of Epidemiology: Initial Results and Some Lessons Learned

    November 8, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Jeffrey (Jerry) G. Jarvik MD MPH Professor, Radiology, Neurological Surgery and Health Services Adjunct Professor, Pharmacy and Orthopedics & Sports Medicine University of Washington Patrick Heagerty, PhD Professor and Chair Department of Biostatistics University of Washington Topic: Lumbar Imaging with Reporting of Epidemiology: Initial Results and Some Lessons Learned Date: Friday, November 8, 2019, […]

  • Fri 15

    Grand Rounds November 15: PCORnet: Health Plan Research Network Data Linkage and Patient Engagement with Patient-Powered Research Networks

    November 15, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Kevin Haynes, PharmD, MSCE Principal Scientist HealthCore Topic: PCORnet: Health Plan Research Network Data Linkage and Patient Engagement with Patient-Powered Research Networks Date: Friday, November 15, 2019, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php. To join […]

  • Thu 21

    IMPACT Collaboratory: Are You Ready for a Pragmatic Trial? The RAPT Model and Implementation Considerations

    November 21, 2019 @ 12:00 pm - 1:00 pm

    Speakers: Rosa Baier, MPH Associate Director, Center for Long-Term Care Quality & Innovation Associate Professor, Health Sciences, Policy & Practice Brown University School of Medicine Eric Jutkowitz, PhD Assistant Professor Brown University School of Public Health Laura Gitlin, PhD, FGSA, FAAN Dean, Distinguished Professor, Drexel University Adjunt Professor, Johns Hopkins University Read more about the […]

  • Fri 22

    Grand Rounds November 22: It’s Time to Learn From Patients Like Mine

    November 22, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Nigam H Shah, MBBS, PhD Associate Professor of Medicine Stanford University Topic: It's Time to Learn From Patients Like Mine Date: Friday, November 22, 2019, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php. To join the online […]

  • Fri 29

    Grand Rounds November 29: No Presentation (Thanksgiving Holiday)

    November 29, 2019 @ 1:00 pm - 2:00 pm
  • December 2019

  • Fri 6

    Grand Rounds December 6: Millions More People, Stronger Collaborations: The New and Improved NIH Collaboratory Distributed Research Network

    December 6, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Richard Platt, MD, MS Professor and Chair Harvard Medical School Department of Population Medicine Kevin Haynes, PharmD, MSCE Principal Scientist HealthCore Denise Boudreau, PhD Senior Scientific Investigator Kaiser Permanente Washington Health Research Institute Jerry H. Gurwitz, MD Professor of Medicine, Family Medicine and Community Health, and Population & Quantitative Health Sciences University of Massachusetts […]

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