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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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  • 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 Date: Friday, April 11, 2025, 1:00-2:00 p.m. ET Please click the link below to join the webinar: https://duke.zoom.us/j/91651086721?pwd=7DftSd42zfX3A3gWZQh3rtinj5SSGr.1 Passcode: 800685 One-Tap Mobile +16469313860,,91651086721#,,,,*800685# US +13017158592,,91651086721#,,,,*800685# […]

  • 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 the Late-Breaking Results of the CLEAR OASIS 9 Trial Date: Friday, April 18, 2025, 1:00-2:00 p.m. ET Please click the link below to join the […]

  • 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 Center Title: Automated Response Technology Integrated into EMR and Physician-Patient Communication Date: Friday, April 25, 2025, 1:00-2:00 p.m. ET Please click the link below to […]

  • 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, May 2, 2025, 1:00-2:00 p.m. ET Please click the link below to join the webinar: https://duke.zoom.us/j/98182851437?pwd=SQsgGAdQYvT82RUrWt8b2EAUKIMbJb.1 Passcode: 476682 One-Tap Mobile +13052241968,,98182851437#,,,,*476682# +13092053325,,98182851437#,,,,*476682# Audio Only Option […]

  • 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 for three half-days from 6-8 May 2025, this virtual event will consist of panel discussions, presentations, an interactive online activity, real world case studies, and […]

  • 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 Policy-Relevant Pragmatic Trial on Acupuncture Effectiveness for Low Back Pain in Older Adults: Clinical and Cost Outcomes and Lessons Learned Date: Friday, May 9, 2025, […]

  • 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 of Medicine Title: Pivoting Clinical Trials Into a New and Evolving World Date: Friday, May 16, 2025, 1:00-2:00 pm ET Please click the link below […]

  • 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 Title: Embedding Randomization Into Clinical Care in Learning Healthcare Systems: Insights From the KP-VACCINATE Megatrial Date: Friday, May 30, 2025, 1:00-2:00 p.m. ET Please click […]

  • 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 Network Project to Support the Needs of Modern Trials Date: Friday, June 6, 2025, 1:00-2:00 p.m. ET Please click the link below to join the […]

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