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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
17 events found.

Events

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  • April 2025

  • 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? […]

  • Fri 27

    Grand Rounds June 27, 2025: The BETTER CARE-HF Study: A Pragmatic Cluster Randomized Trial to Improve Heart Failure Care (Amrita Mukhopadhyay, MD, MS)

    June 27, 2025 @ 1:00 pm - 2:00 pm

    Speaker: Amrita Mukhopadhyay, MD, MS Eugene Braunwald, MD Assistant Professor of Cardiology The Leon H. Charney Division of Cardiology Department of Medicine Division of Healthcare Delivery Science Department of Population Health NYU School of Medicine NYU Langone Health Title: The BETTER CARE-HF Study: A Pragmatic Cluster Randomized Trial to Improve Heart Failure Care Date: Friday, […]

  • July 2025

  • Fri 11

    Grand Rounds July 11, 2025: Novel Approaches to Recruiting Clinical Sites for Embedded Pragmatic Clinical Trials: Insights From the AIM-Back Trial (Tyler Cope, PT, DPT, ATC; Trevor Lentz, PT, PhD, MPH)

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

    Speakers: Tyler Cope, PT, DPT, ATC Duke Clinical Research Institute Department of Population Health Sciences, Duke University School of Medicine Trevor Lentz, PT, PhD, MPH Associate Professor Department of Orthopaedic Surgery, Duke University School of Medicine Duke Clinical Research Institute Title: Novel Approaches to Recruiting Clinical Sites for Embedded Pragmatic Clinical Trials: Insights From the […]

  • Fri 18

    Grand Rounds July 18, 2025: State of Clinical Trials: An Analysis of ClinicalTrials.gov (Adrian F. Hernandez, MD, MHS; Rebecca D. Sullenger, MPH; Sara Bristol Calvert, PharmD; Karen Chiswell, PhD; Christopher J. Lindsell, PhD)

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

    Speakers: Adrian F. Hernandez, MD, MHS Executive Director Duke Clinical Research Institute Rebecca D. Sullenger, MPH Duke University School of Medicine MD Student | Class of 2026 Panelists: Sara Bristol Calvert, PharmD Director of Projects Clinical Trials Transformation Initiative Karen Chiswell, PhD Statistical Scientist Duke Clinical Research Institute Christopher J. Lindsell, PhD Director, Data Science […]

  • Fri 25

    Grand Rounds July 25, 2025: Initial Outcomes of the NOHARM Pragmatic Trial (Jon Tilburt, MD; Andrea Cheville, MD)

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

    Speakers: Jon Tilburt, MD Professor of Medicine Mayo Clinic in Arizona Andrea Cheville, MD Professor of Physical Medicine and Rehabilitation Mayo Clinic in Minnesota Title: Initial Outcomes of the NOHARM Pragmatic Trial Date: Friday, July 25, 2025, 1:00-2:00 pm ET Please click the link below to join the webinar: https://duke.zoom.us/j/93418674002?pwd=JFjej9bNfk63klAQGaraAXyXAicNzb.1 Passcode: 851356 One-Tap Mobile +16468769923,,93418674002#,,,,*851356# […]

  • August 2025

  • Fri 1

    Grand Rounds August 1, 2025: Clinical Trial Notifications Triggered by Artificial Intelligence–Detected Cancer Progression (Kenneth L. Kehl, MD, MPH)

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

    Speaker: Kenneth L. Kehl, MD, MPH Assistant Professor of Medicine and Physician Dana-Farber Cancer Institute Title: Clinical Trial Notifications Triggered by Artificial Intelligence–Detected Cancer Progression Date: Friday, August 1, 2025, 1:00-2:00 p.m. ET Please click the link below to join the webinar: https://duke.zoom.us/j/93763570190?pwd=NZuKyNxOw7MnGpCdgfO47KB7BYt51Z.1 Passcode: 604105 One-Tap Mobile +16468769923,,93763570190#,,,,*604105# +16469313860,,93763570190#,,,,*604105# Audio Only Option +1 646 876 […]

  • Fri 8

    Grand Rounds August 8, 2025: Varenicline for Youth Nicotine Vaping Cessation: A Randomized Clinical Trial (A. Eden Evins, MD, MPH)

    August 8, 2025 @ 1:00 pm - 2:00 pm

    Speaker: A. Eden Evins, MD, MPH Cox Family Professor of Psychiatry, Harvard Medical School Founding Director, MGH Center for Addiction Medicine Director for Faculty Development, Mass General Hospital Department of […]

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