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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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  • July 2023

  • Fri 7

    Grand Rounds July 7, 2023: Implementing Virtual Strategies Across an Integrated Healthcare System: The IMPLEMENT-HF Study (Ankeet S. Bhatt, MD, MBA, ScM)

    July 7, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Ankeet S. Bhatt, MD, MBA, ScM Associate Physician, Kaiser Permanente San Francisco Medical Center Research Scientist, Kaiser Permanente Northern California Division of Research Topic: Implementing Virtual Strategies Across an Integrated Healthcare System: The IMPLEMENT-HF Study Date: Friday, July 7, 2023, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link below: […]

  • Fri 14

    Grand Rounds July 14, 2023: Lessons From the COORDINATE-Diabetes Trial (Christopher B. Granger, MD; Neha J. Pagidipati, MD, MPH)

    July 14, 2023 @ 1:00 pm - 2:00 pm

    Speakers: Christopher B. Granger, MD Donald F. Fortin, M.D. Distinguished Professor of Medicine Professor of Nursing Duke University Neha J. Pagidipati, MD MPH Associate Professor of Medicine, Duke University School of Medicine Topic: Lessons from the COORDINATE-Diabetes Trial Date: Friday, July 14, 2023, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting […]

  • Fri 21

    Grand Rounds July 21, 2023: Implementing New Care Pathways for Low Back Pain in Academic Healthcare Systems: Early Lessons From IMPACt-LBP (Christine Goertz, DC, PhD; Adam Goode, DPT, PhD)

    July 21, 2023 @ 1:00 pm - 2:00 pm

    Speakers: Christine Goertz, DC, PhD Professor in Musculoskeletal Research Vice Chair for Implementation of Spine Health Innovations Department of Orthopaedic Surgery Duke University Adam Goode, DPT, PhD Associate Professor in Orthopaedic Surgery Vice Chair of Clinical Research and Epidemiology Department of Orthopaedic Surgery Duke University Topic: Implementing New Care Pathways for Low Back Pain in […]

  • Fri 28

    Grand Rounds July 28, 2023: How Can Researchers Fight Misinformation About Medicine? (Carl T. Bergstrom, PhD)

    July 28, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Carl T. Bergstrom, PhD Professor, Department of Biology University of Washington Topic: How Can Researchers Fight Misinformation About Medicine? Date: Friday, July 28, 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# US (New York) +16469313860,,96153659804#,,,,*12345# […]

  • August 2023

  • Fri 4

    Grand Rounds August 4, 2023: AI & ML: Want to Play a Game? (Eric Perakslis, PhD)

    August 4, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Eric Perakslis, PhD Chief Science & Digital Officer Duke Clinical Research Institute Professor, Department of Population Health Sciences Chief Research Technology Strategist Duke University School of Medicine Topic: AI & ML: Want to Play a Game? Date: Friday, August 4, 2023, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link […]

  • Fri 11

    Grand Rounds August 11, 2023: The REMAP-CAP Adaptive Platform Trial: Recent Insights and Future Directions (Patrick Lawler, MD, MPH)

    August 11, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Patrick Lawler, MD, MPH Cardiology and Critical Care Divisions McGill University and University of Toronto Topic: The REMAP-CAP Adaptive Platform Trial: Recent Insights and Future Directions Date: Friday, August 11, 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 […]

  • 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. […]

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