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Living Textbook of
Pragmatic Clinical Trials

COVID-19 Resources

Access the latest information on COVID-19 for clinical researchers
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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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  • October 2022

  • Fri 21

    Grand Rounds October 21: Disinformation, Cyberthreat, and Choice: Protecting Patients and Clinical Research From the Digital Triple Threat (Eric Perakslis, PhD; Andrea Downing)

    October 21, 2022 @ 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 Andrea Downing ePatient and Security Researcher Co-Founder - The Light Collective Topic: Disinformation, Cyberthreat, and Choice: Protecting Patients and Clinical Research From the Digital Triple Threat Date: […]

  • Fri 28

    Grand Rounds October 28: The HERO (Healthcare Worker Exposure Response & Outcomes) Program: An Online Community to Support Observational Studies, Randomized Trials, and Long-Term Safety Surveillance (Emily O’Brien, PhD, FAHA; Russell Rothman, MD, MPP)

    October 28, 2022 @ 1:00 pm - 2:00 pm

    Speaker: Emily O’Brien, PhD, FAHA Associate Professor Duke Clinical Research Institute Duke University School of Medicine Department of Population Health Sciences Russell Rothman, MD, MPP Senior Vice President, Population and Public Health Director, Vanderbilt Institute for Medicine and Public Health Vanderbilt University Medical Center Topic: The HERO (Healthcare Worker Exposure Response & Outcomes) Program: An […]

  • November 2022

  • Thu 3

    Toward Causal Inference in Cluster Randomized Trials: Estimands and Reflection on Current Practice

    November 3, 2022 @ 3:00 pm

    Methods: Minds the Gap Webinar Series "Toward Causal Inference in Cluster Randomized Trials: Estimands and Reflection on Current Practice" Fan Li, PhD; Yale School of Public Health National Institutes of Health, Office of Disease Prevention Cluster randomized trials (CRTs) involve randomizing groups of individuals to different interventions. While model-based methods are extensively studied for analyzing […]

  • Fri 4

    Grand Rounds November 4, 2022: The CardioNerds Clinical Trials Network: Pairing Equitable Enrollment With Trainee Development (Amit Goyal, MD, MAS)

    November 4, 2022 @ 1:00 pm - 2:00 pm

    Speaker: Amit Goyal, MD, MAS Interventional/Structural Fellow, Cleveland Clinic Cofounder of CardioNerds Topic: The CardioNerds Clinical Trials Network: Pairing Equitable Enrollment With Trainee Development Date: Friday, November 4, 2022, 1:00-2:00 p.m. ET   Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php. […]

  • Fri 11

    Grand Rounds Ethics and Regulatory Series November 11: Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst a Changing Policy Landscape (Stephanie Morain, PhD, MPH; Kayte Spector-Bagdady, JD, MBioethics)

    November 11, 2022 @ 1:00 pm - 2:00 pm

    Speaker: Stephanie Morain, PhD, MPH Assistant Professor Berman Institute of Bioethics & Johns Hopkins Bloomberg School of Public Health Kayte Spector-Bagdady, JD, MBioethics Associate Director, Center for Bioethics & Social […]

  • Fri 18

    Grand Rounds November 18, 2022: The FIRST-ABC Pragmatic Trials of Non-Invasive Respiratory Support In Children (Padmanabhan Ramnarayan, MBBS, MD, FRCPCH, FFICM)

    November 18, 2022 @ 1:00 pm - 2:00 pm

    Speaker: Padmanabhan Ramnarayan (Ram), MBBS, MD, FRCPCH, FFICM Reader in Pediatric Critical Care Imperial College London Topic: The FIRST-ABC Pragmatic Trials of Non-Invasive Respiratory Support In Children Date: Friday, November […]

  • December 2022

  • Fri 2

    Grand Rounds December 2, 2022: A Randomized Controlled Trial of a Mobile Health Intervention in Heart Failure and Diabetes: Lessons Learned (G. Michael Felker, MD, MHS)

    December 2, 2022 @ 1:00 pm - 2:00 pm

    Speaker: G. Michael Felker, MD, MHS Professor of Medicine Director, Cardiovascular and Metabolism Research, DCRI Topic: A Randomized Controlled Trial of a Mobile Health Intervention in Heart Failure and Diabetes: […]

  • Fri 9

    Grand Rounds Ethics and Regulatory Series December 9: The Stepped-Wedge Cluster Randomized Trial: Friend or Foe? (Monica Taljaard, PhD; David Magnus, PhD)

    December 9, 2022 @ 1:00 pm - 2:00 pm

    Speaker: Monica Taljaard, PhD Senior Scientist, Clinical Epidemiology Program Ottawa Hospital Research Institute Full Professor, Epidemiology and Community Medicine University of Ottawa David Magnus, PhD Thomas A. Raffin Professor of […]

  • Fri 16

    Grand Rounds December 16, 2022: The Use of EHR-Agnostic Clinical Decision Support to Prevent Thromboembolism in Hospitalized Medically Ill Patients (Alex C. Spyropoulos, MD, FACP, FCCP, FRCPC; Jeffrey Solomon, BFA)

    December 16, 2022 @ 1:00 pm - 2:00 pm

    Speaker: Alex C. Spyropoulos, MD, FACP, FCCP, FRCPC Professor of Medicine – The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Professor - Institute of Health System Science - […]

  • January 2023

  • Fri 6

    Grand Rounds January 6, 2023: Outpatient Treatment of COVID-19 With Metformin, Ivermectin, or Fluvoxamine: 10-Month Follow-up and Effects on Developing Long COVID (Carolyn Bramante, MD, MPH; Thomas Murray, PhD)

    January 6, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Carolyn Bramante, MD, MPH Division of General Internal Medicine Departments of Internal Medicine and Pediatrics Core faculty in the Program in Health Disparities Research and the Center for Pediatric […]

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