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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
10 events found.

Events

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  • May 2019

  • Fri 24

    Grand Rounds May 24: No Presentation (Memorial Day Holiday)

    May 24, 2019 @ 1:00 pm - 2:00 pm
  • Fri 31

    Grand Rounds May 31: Adapting Clinical Trial Design to Meet the Needs of Learning Health Systems

    May 31, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Harriette G.C. Van Spall, MD, MPH, FRCPC Associate Professor of Medicine Department of Medicine, Division of Cardiology Department of Health Research Methods, Evidence, and Impact McMaster University Population Health Research Institute Topic: Adapting Clinical Trial Design to Meet the Needs of Learning Health Systems Date: Friday, May 31, 2019, 1:00-2:00 p.m. ET Meeting Info: To […]

  • June 2019

  • Fri 7

    Grand Rounds June 7: In Dreams Begin Responsibilities: Data Science as a Service—Using AI to Risk Stratify a Medicare Population and Build a Culture

    June 7, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Erich S. Huang, MD, PhD Co-Director, Duke Forge Departments of Biostatistics & Bioinformatics and Surgery Duke University School of Medicine Topic: In Dreams Begin Responsibilities: Data Science as a Service—using AI to Risk Stratify a Medicare Population and Build a Culture Date: Friday, June 7, 2019, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the […]

  • Fri 14

    Grand Rounds June 14: Good Clinical Practice Guidance and Pragmatic Trials: Balancing the Best of Both Worlds in the Learning Health System

    June 14, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Robert J. Mentz, MD, FACC, FAHA, FHFSA Associate Professor Director, Duke Cooperative Cardiovascular Society Associate Program Director, Duke Cardiovascular Disease Fellowship Duke University Medical Center and Duke Clinical Research Institute Topic: Good Clinical Practice Guidance and Pragmatic Trials: Balancing the Best of Both Worlds in the Learning Health System Date: Friday, June 14, 2019, 1:00-2:00 […]

  • Fri 21

    Grand Rounds June 21: A Polypill Strategy for Cardiovascular Prevention in Underserved Populations – Can We Bridge the Gap?

    June 21, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Daniel Muñoz, MD, MPA Assistant Professor of Medicine Division of Cardiology Vanderbilt University Medical Center Thomas J. Wang, MD Professor of Medicine Gottlieb C. Friesinger II Chair in Cardiovascular Medicine Director, Division of Cardiovascular Medicine Vanderbilt University Medical Center Physician-in-Chief, Vanderbilt Heart & Vascular Institute Topic: A Polypill Strategy for Cardiovascular Prevention in Underserved […]

  • Fri 28

    Grand Rounds June 28: Moving Beyond Return of Research Results to Return of Value

    June 28, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Consuelo H. Wilkins, MD, MSCI Vice President for Health Equity, Vanderbilt University Medical Center Executive Director, Meharry-Vanderbilt Alliance Topic: Moving Beyond Return of Research Results to Return of Value Date: Friday, June 28, 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 […]

  • July 2019

  • Fri 5

    Grand Rounds July 5: No Presentation (Independence Day Holiday)

    July 5, 2019 @ 1:00 pm - 2:00 pm
  • Fri 12

    Grand Rounds July 12: medRxiv: A Paradigm Shift in Disseminating Clinical and Public Health Research

    July 12, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Harlan M. Krumholz, MD, SM Harold H. Hines, Jr. Professor of Medicine and Public Health Yale University Joseph S. Ross, MD, MHS Associate Professor of Medicine and Public Health Yale University Topic: medRxiv: A Paradigm Shift in Disseminating Clinical and Public Health Research Date: Friday, July 12, 2019, 1:00-2:00 p.m. ET Meeting Info: To […]

  • Fri 19

    Grand Rounds July 19: Misinformation as a Source of Complication for Clinical Trials

    July 19, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Brian Southwell, PhD Senior Director, Science in the Public Sphere, RTI International Duke-RTI Scholar, Duke Forge, Duke University Topic: Misinformation as a Source of Complication for Clinical Trials Date: Friday, July 19, 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 […]

  • Fri 26

    Grand Rounds July 26: Digital in Trials: Improving Participation and Enabling Novel Endpoints

    July 26, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Craig H. Lipset Former Head of Clinical Innovation Pfizer Topic: Digital in Trials: Improving Participation and Enabling Novel Endpoints Date: Friday, July 26, 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: […]

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