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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
13 events found.

Events

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  • March 2025

  • Fri 28

    Grand Rounds March 28, 2025: A Cross-Sectional Study of GPT-4–Based Plain Language Translation of Clinical Notes to Improve Patient Comprehension of Disease Course and Management (Matthew Engelhard, MD, PhD; Anivarya Kumar, BA)

    March 28, 2025 @ 1:00 pm - 2:00 pm

    Speakers: Matthew Engelhard, MD, PhD Assistant Professor, Department of Biostatistics & Bioinformatics Duke University School of Medicine Anivarya Kumar, BA Fourth-Year Medical Student Duke University School of Medicine Title: A […]

  • April 2025

  • Fri 4

    Grand Rounds April 4, 2025: A Digital Health Behavior Intervention to Prevent Childhood Obesity: The Greenlight Plus Randomized Clinical Trial (Bill Heerman, MD, MPH)

    April 4, 2025 @ 1:00 pm - 2:00 pm

    Speaker: Bill Heerman, MD, MPH Associate Professor of Internal Medicine and Pediatrics William K. Warren Foundation Chair in Medicine Chief, Division of Academic General Pediatrics Vanderbilt University Medical Center Title: […]

  • Fri 11

    Grand Rounds April 11, 2025: A Phase 2 Trial of Pridopidine in ALS, Studied as a Regimen With the Healey Platform Trial (Jeremy M. Shefner, MD, PhD)

    April 11, 2025 @ 1:00 pm - 2:00 pm

    Speaker: Jeremy M. Shefner, MD, PhD Professor of Neurology Barrow Neurological Institute Title: A Phase 2 Trial of Pridopidine in ALS, Studied as a Regimen With the Healey Platform Trial […]

  • Fri 18

    Grand Rounds April 18, 2025: Colchicine and Spironolactone Post-MI: A Review of the Late-Breaking Results of the CLEAR OASIS 9 Trial (Sanjit S. Jolly, MD, MSc, FRCPC)

    April 18, 2025 @ 1:00 pm - 2:00 pm

    Speaker: Sanjit S. Jolly, MD, MSc, FRCPC Interventional Cardiologist, Hamilton Health Sciences Stuart Connolly Chair in Cardiology Professor of Medicine, McMaster University Title: Colchicine and Spironolactone Post-MI: A Review of […]

  • Fri 25

    Grand Rounds April 25, 2025: Automated Response Technology Integrated into EMR and Physician-Patient Communication (Ming Tai-Seale, PhD, MPH)

    April 25, 2025 @ 1:00 pm - 2:00 pm

    Speaker: Ming Tai-Seale, PhD, MPH Professor Departments of Family Medicine and Medicine (Bioinformatics) University of California San Diego School of Medicine Director of UC San Diego Learning Health Systems Science […]

  • May 2025

  • Fri 2

    Grand Rounds May 2, 2025: Fluid REStriction in Heart failure versus liberal fluid UPtake: The FRESH-UP Study (Roland RJ van Kimmenade, MD, PhD)

    May 2, 2025 @ 1:00 pm - 2:00 pm

    Speaker: Roland RJ van Kimmenade, MD, PhD  Cardiologist, Radboud University Medical Center Nijmegen, the Netherlands Title: Fluid REStriction in Heart failure versus liberal fluid UPtake: The FRESH-UP Study Date: Friday, […]

  • Tue 6

    What Does it Mean to Implement PROMs in Clinical Practice? (ISOQOL)

    May 6, 2025 @ 9:00 am - 12:00 pm

    Register today to attend the ISOQOL 1st Virtual Symposium, an event focused on challenges that healthcare providers (HCPs) encounter in the integration of patient-reported outcome measures (PROMs) into routine practice. Scheduled […]

  • Fri 9

    Grand Rounds May 9, 2025: A Policy-Relevant Pragmatic Trial on Acupuncture Effectiveness for Low Back Pain in Older Adults: Clinical and Cost Outcomes and Lessons Learned (Andrea J. Cook, PhD; Lynn L. DeBar, PhD, MD; Patricia M. Herman, PhD, ND)

    May 9, 2025 @ 1:00 pm - 2:00 pm

    Speakers: Andrea J. Cook, PhD Kaiser Permanente Washington Health Research Institute Lynn L. DeBar, PhD, MPH Kaiser Permanente Center for Health Research Patricia M. Herman, PhD, ND RAND Title: A […]

  • Fri 16

    Grand Rounds May 16, 2025: Pivoting Clinical Trials Into a New and Evolving World (Jeffrey A. Spaeder, MD; Adrian F. Hernandez, MD, MHS)

    May 16, 2025 @ 1:00 pm - 2:00 pm

    Speakers: Jeffrey A. Spaeder, MD Chief Medical and Scientific Officer Senior Vice President IQVIA Adrian F. Hernandez, MD, MHS Executive Director Duke Clinical Research Institute Vice Dean Duke University School […]

  • Fri 30

    Grand Rounds May 30, 2025: Embedding Randomization Into Clinical Care in Learning Healthcare Systems: Insights From the KP-VACCINATE Megatrial (Ankeet S. Bhatt, MD, MBA, ScM)

    May 30, 2025 @ 1:00 pm - 2:00 pm

    Speaker: Ankeet S. Bhatt, MD, MBA, ScM Cardiologist, Kaiser Permanente San Francisco Medical Center Research Scientist, Kaiser Permanente Northern California Division of Research Adjunct Professor, Stanford University School of Medicine […]

  • June 2025

  • Fri 6

    Grand Rounds June 6, 2025: The REDCap Advanced Randomization Module: A Trial Innovation Network Project to Support the Needs of Modern Trials (Jonathan D. Casey, MD, MSc)

    June 6, 2025 @ 1:00 pm - 2:00 pm

    Speaker: Jonathan D. Casey, MD, MSc Assistant Professor Co-PI, Vanderbilt Trial Innovation Center Director, Coordinating Center, Pragmatic Critical Care Research Group Title: The REDCap Advanced Randomization Module: A Trial Innovation […]

  • Fri 13

    Grand Rounds June 13, 2025: Fit for Purpose: Improving the Ethical Oversight of Pragmatic Clinical Trials (Stephanie Morain, PhD, MPH; Nancy Kass, ScD; Ruth Faden, PhD, MPH)

    June 13, 2025 @ 1:00 pm - 2:00 pm

    Speakers: Stephanie Morain, PhD, MPH Associate Professor, Berman Institute of Bioethics & Department of Health Policy & Management Johns Hopkins University Nancy Kass, ScD Phoebe Berman Professor of Bioethics & […]

  • Fri 20

    Grand Rounds June 20, 2025: The BedMed Trials: Does the Timing of Blood Pressure Medication Matter? (Scott Garrison MD, PhD, CCFP)

    June 20, 2025 @ 1:00 pm - 2:00 pm

    Speaker: Scott Garrison MD, PhD, CCFP Professor, University of Alberta, Department of Family Medicine Director, Pragmatic Trials Collaborative Title: The BedMed Trials: Does the Timing of Blood Pressure Medication Matter? […]

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