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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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Today
  • August 2023

  • Fri 18

    Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH; Adrian F. Hernandez, MD, MHS)

    August 18, 2023 @ 1:00 pm - 2:00 pm

    Speakers: Prof Sir Martin Landray, FMedSci Professor of Medicine & Epidemiology University of Oxford Chief Executive, Protas Khair ElZarrad, PhD, MPH Director, Office of Medical Policy Center for Drug Evaluation and Research (CDER) U.S. Food and Drug Administration (FDA) Adrian F. Hernandez, MD, MHS Vice Dean and Executive Director Duke Clinical Research Institute Duke University […]

  • Fri 25

    Grand Rounds August 25, 2023: Pragmatic Trial of an EHR Application to Display Real-Time PRO Data: Successes and Challenges (Gabriela Schmajuk, MD, MS)

    August 25, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Gabriela Schmajuk, MD, MS Professor of Medicine UCSF and the San Francisco VA Topic: Pragmatic Trial of an EHR Application to Display Real-Time PRO Data: Successes and Challenges Date: Friday, August 25, 2023, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link below: https://duke.zoom.us/j/96153659804?pwd=VmNJVDE5VmtFbUFHY0lZeTM1K0Y5QT09 Meeting ID: 961 5365 9804 Passcode: […]

  • September 2023

  • Fri 8

    Grand Rounds September 8, 2023: The DEVICE Trial: An Embedded, Pragmatic Trial of Emergency Airway Management (Matthew Prekker, MD, MPH; Jonathan Casey, MD, MSc)

    September 8, 2023 @ 1:00 pm - 2:00 pm

    Speakers: Matthew Prekker, MD, MPH Associate Professor of Emergency Medicine and Pulmonary and Critical Care Medicine Hennepin County Medical Center University of Minnesota Medical School Jonathan Casey, MD, MSc Assistant Professor of Pulmonary and Critical Care Vanderbilt University Medical Center Director, Coordinating Center, Pragmatic Critical Care Research Group Topic: The DEVICE Trial: An Embedded, Pragmatic […]

  • Tue 12

    Advancing Justice and Equity in Pragmatic Clinical Trials

    September 12, 2023 @ 11:00 am - 12:30 pm

    VA HSR&D Cyberseminars: Spotlight on Pain Management "Advancing Justice and Equity in Pragmatic Clinical Trials" Joe Ali, PhD Johns Hopkins University Advance registration required. "Pragmatic clinical trials (PCTs) can help bring evidence‐based therapies to people living with pain and co‐occurring conditions, with an emphasis on developing insights that are relevant to patients, practitioners and others. […]

  • Fri 15

    Grand Rounds September 15, 2023: Effect of Financial Incentives and Default Options on Food Choices of Adults With Low Income in Online Retail Settings (Pasquale Rummo, PhD, MPH)

    September 15, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Pasquale Rummo, PhD, MPH Associate Professor NYU Grossman School of Medicine Topic: Effect of Financial Incentives and Default Options on Food Choices of Adults With Low Income in Online Retail Settings Date: Friday, September 15, 2023, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link below: https://duke.zoom.us/j/96153659804?pwd=VmNJVDE5VmtFbUFHY0lZeTM1K0Y5QT09 Meeting ID: 961 […]

  • Fri 22

    Grand Rounds September 22, 2023: Community Health Workers in Early Childhood Well-Child Care (Tumaini Rucker Coker, MD, MBA)

    September 22, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Tumaini Rucker Coker, MD, MBA Professor of Pediatrics Division Head for General Pediatrics University of Washington Department of Pediatrics Seattle Children's Hospital Topic: Community Health Workers in Early Childhood Well-Child Care Date: Friday, September 22, 2023, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link below: https://duke.zoom.us/j/96153659804?pwd=VmNJVDE5VmtFbUFHY0lZeTM1K0Y5QT09 Meeting ID: 961 […]

  • Fri 29

    Grand Rounds September 29, 2023: Navigating the Use of Patient-Reported Outcomes in Research and Practice: The PROTEUS Consortium (Claire Snyder, PhD; Norah Crossnohere, PhD; Anne Schuster, PhD)

    September 29, 2023 @ 1:00 pm - 2:00 pm

    Speakers: Claire Snyder, PhD Professor Johns Hopkins Schools of Medicine and Public Health Norah Crossnohere, PhD Assistant Professor Ohio State University College of Medicine Anne Schuster, PhD Research Scientist Ohio State University College of Medicine Topic: Navigating the Use of Patient-Reported Outcomes in Research and Practice: The PROTEUS Consortium Date: Friday, September 29, 2023, 1:00-2:00 […]

  • October 2023

  • Fri 6

    Grand Rounds Biostatistics Series October 6, 2023: Hybrid Studies Should Not Sacrifice Rigorous Methods (David M. Murray, PhD; Moderator: Jonathan Moyer, PhD)

    October 6, 2023 @ 1:00 pm - 2:00 pm

    Speaker: David M. Murray, PhD NIH Associate Director for Prevention and Director, NIH Office of Disease Prevention Moderator: Jonathan C. Moyer, PhD Statistician, NIH Office of Disease Prevention Topic: Hybrid Studies Should Not Sacrifice Rigorous Methods Date: Friday, October 6, 2023, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link below: https://duke.zoom.us/j/96153659804?pwd=VmNJVDE5VmtFbUFHY0lZeTM1K0Y5QT09 Meeting […]

  • Fri 13

    Grand Rounds October 13, 2023: Incorporating Social Determinants of Health Into PCORnet (Keith Marsolo, PhD)

    October 13, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Keith Marsolo, PhD Associate Professor, Department of Population Health Sciences, Duke University School of Medicine Topic: Incorporating Social Determinants of Health Into PCORnet Date: Friday, October 13, 2023, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link below: https://duke.zoom.us/j/96153659804?pwd=VmNJVDE5VmtFbUFHY0lZeTM1K0Y5QT09 Meeting ID: 961 5365 9804 Passcode: 12345 One tap mobile +16468769923,,96153659804#,,,,*12345# […]

  • Fri 20

    Grand Rounds October 20, 2023: A National Initiative to Eliminate Hepatitis C in the United States – Why This Matters to Clinical Trialists (Rachael L. Fleurence, PhD, MSc; Joshua M. Sharfstein, MD)

    October 20, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Rachael L. Fleurence, PhD, MSc  Senior Advisor National Institutes of Health Joshua M. Sharfstein, MD Vice Dean for Public Health Practice and Community Engagement Director, Bloomberg American Health Initiative Professor of the Practice in Health Policy and Management Topic: A National Initiative to Eliminate Hepatitis C in the United States - Why This Matters […]

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