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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 2024

  • Fri 5

    Grand Rounds April 5, 2024: A New Look at P Values for Randomized Clinical Trials (Erik van Zwet, PhD)

    April 5, 2024 @ 1:00 pm - 2:00 pm

    Speaker: Erik van Zwet, PhD Department of Biomedical Data Sciences Leiden University Medical Center, the Netherlands Title: A New Look at P Values for Randomized Clinical Trials Date: Friday, April 5, 2024, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link below: https://duke.zoom.us/j/98292370425?pwd=S05sOU42WXp3NXNjK0ZkczN0WXpHUT09 Meeting ID: 982 9237 0425 Passcode: 237056 One […]

  • Fri 5

    2024 Allan Donner Lecture: The Unit of Inference in Cluster Randomized Trials

    April 5, 2024 @ 1:30 pm - 2:30 pm

    2024 Allan Donner Lecture: Dr. Fan Li Date: Friday, April 5 Time: 1:30 pm - 2:30 pm Location: PHFM 3015 (Western Centre for Public Health and Family Medicine) or Zoom (link may be […]

  • Fri 12

    Grand Rounds April 12, 2024: Primary Palliative Care for Emergency Medicine, a Cluster Randomized Stepped-Wedge Trial Across 33 Emergency Departments (Corita R. Grudzen, MD, MSHS, FACEP)

    April 12, 2024 @ 1:00 pm - 2:00 pm

    Speaker: Corita R. Grudzen, MD, MSHS, FACEP Fern Grayer Chair in Oncology Care and the Patient Experience Division Head, Supportive and Acute Care Services Memorial Sloan Kettering Cancer Center Professor of Emergency Medicine Weill Cornell Medical College Title: Primary Palliative Care for Emergency Medicine, A Cluster Randomized Stepped-Wedge Trial Across 33 Emergency Departments Date: Friday, […]

  • Fri 19

    Grand Rounds April 19, 2024: The Yale Open Data Access (YODA) Project: 10 Years of Clinical Trial Data Sharing (Joseph S. Ross, MD, MHS)

    April 19, 2024 @ 1:00 pm - 2:00 pm

    Speaker: Joseph S. Ross, MD, MHS Professor of Medicine and Public Health Yale University Title: The Yale Open Data Access (YODA) Project: 10 Years of Clinical Trial Data Sharing Date: Friday, April 19, 2024, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link below: https://duke.zoom.us/j/93696931854?pwd=dXUySnkzYkNwK1NQeHVHWjRKR1ptUT09 Meeting ID: 936 9693 1854 Passcode: […]

  • Fri 26

    Grand Rounds April 26, 2024: Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations – FDA Regulation Development and Research Landscape (Lauren Milner, PhD; Jonathan Casey, MD, MSCI; Matthew Semler, MD, MSCI)

    April 26, 2024 @ 1:00 pm - 2:00 pm

    Speakers: Lauren Milner, PhD Office of Clinical Policy US Food and Drug Administration  (FDA) Jonathan Casey, M.D., MSCI Assistant Professor, Division of Pulmonary and Critical Care Medicine Vanderbilt University Medical Center Director, Coordinating Center Pragmatic Critical Care Research Group Matthew Semler, M.D., MSCI Associate Professor, Division of Pulmonary and Critical Care Medicine Vanderbilt University Medical […]

  • May 2024

  • Fri 3

    Grand Rounds May 3, 2024: Comparative Effectiveness of Kidney Stone Surgery in Pediatric Patients: The PKIDS Trial (Gregory Tasian, MD, MSc, MSCE)

    May 3, 2024 @ 1:00 pm - 2:00 pm

    Speaker: Gregory Tasian, MD, MSc, MSCE Associate Professor of Surgery and Epidemiology Children’s Hospital of Philadelphia Title: Comparative Effectiveness of Kidney Stone Surgery in Pediatric Patients: The PKIDS Trial Date: Friday, May 3, 2024, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link below: https://duke.zoom.us/j/92733839047?pwd=MkNISkRqK2RsQmVxK254SVdOQ2plZz09 Meeting ID: 927 3383 9047 Passcode: […]

  • Fri 17

    Grand Rounds May 17, 2024: CardioHealth Alliance: A Platform to Improve Care (Ken Mahaffey, MD; Nishant Shah, MD; Neha Pagidipati, MD, MPH)

    May 17, 2024 @ 1:00 pm - 2:00 pm

    Speaker: Ken Mahaffey, MD Professor of Cardiovascular Medicine Associate Dean for Clinical Research, School of Medicine Vice Chair for Clinical Research, Department of Medicine Director, Stanford Center for Clinical Research (SCCR) Stanford University Nishant Shah, MD Assistant Professor of Medicine Duke University School of Medicine The REVEAL Project: Identifying Real World Gaps and Areas for […]

  • Fri 31

    Grand Rounds May 31, 2024: The INSPIRE Abdominal & Skin/Soft Tissue Infection Trials: INtelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection for Patients (Shruti Gohil, MD, MPH)

    May 31, 2024 @ 1:00 pm - 2:00 pm

    Speaker: Shruti Gohil, MD MPH, Assistant Professor Infectious Diseases University of California, Irvine Title: The INSPIRE Abdominal & Skin/Soft Tissue Infection Trials: INtelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection for Patients Date: Friday, May 31, 2024, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link below: https://duke.zoom.us/j/94488395753?pwd=QnFxSmZvUFBSblIvZ2NHYnRYc3Y4QT09 Meeting ID: […]

  • June 2024

  • Fri 7

    Grand Rounds June 7, 2024: The NIH COvid-19 and Diabetes Assessment (CODA) Study: Leveraging PCORnet For A Novel Cohort Study (Russell Rothman, MD, MPP; Jason Block, MD)

    June 7, 2024 @ 1:00 pm - 2:00 pm

    Speakers: Russell Rothman, MD, MPP Professor, Internal Medicine, Pediatrics, & Health Policy Senior Vice President, Population and Public Health Director, Institute for Medicine and Public Health Jason Block, MD Assistant Professor, Harvard Medical School Faculty Member, Harvard Center for Population and Development Studies Physician, Brigham and Women's Hospital Title: The NIH COvid-19 and Diabetes Assessment […]

  • Fri 14

    Grand Rounds June 14, 2024: DAPA-MI – A Pragmatic Registry-Based Double-Blind RCT Trial Designed For Regulatory Evaluation (Stefan James; Jonas Oldgren)

    June 14, 2024 @ 1:00 pm - 2:00 pm

    Speakers: Stefan James Professor Cardiology Dept. of Medical Sciences and Uppsala Clinical Research Center Uppsala University Uppsala, Sweden Jonas Oldgren Professor Cardiology Dept. of Medical Sciences and Uppsala Clinical Research Center Uppsala University Uppsala, Sweden Title: DAPA-MI - A Pragmatic Registry-Based Double-Blind RCT Trial Designed For Regulatory Evaluation Date: Friday, June 14, 2024, 1:00-2:00 p.m. […]

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