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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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  • July 2022

  • Fri 15

    Grand Rounds July 15: Overview of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Public-Private Partnership and Lessons Learned (Stacey J. Adam, PhD)

    July 15, 2022 @ 1:00 pm - 2:00 pm

    Speaker: Stacey J. Adam, PhD Associate Vice President, Research Partnerships Foundation for the NIH   Topic: Overview of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Public-Private Partnership and Lessons Learned […]

  • Fri 22

    Grand Rounds July 22: ACTIV-6: One Year Later and Trial Results for Ivermectin-400 and Inhaled Fluticasone (Susanna Naggie, MD, MHS)

    July 22, 2022 @ 1:00 pm - 2:00 pm

    Speaker: Susanna Naggie, MD, MHS Professor of Medicine Vice Dean for Clinical Research Duke University School of Medicine Infectious Diseases Research Duke Clinical Research Institute   Topic: ACTIV-6: 1-year Later […]

  • Fri 29

    Grand Rounds July 29: Effect of Early Treatment With Single-Dose Pegylated Interferon Lambda Among Patients With COVID-19: Results From the TOGETHER Trial (Edward Mills, PhD, FRCP; Jeffrey S. Glenn, MD, PhD)

    July 29, 2022 @ 1:00 pm - 2:00 pm

    Speakers: Edward Mills, PhD, FRCP Professor Department of Health Research Methods, Evidence & Impact McMaster University, Canada Jeffrey S. Glenn, MD, PhD Joseph D. Grant Professor and Professor of Microbiology […]

  • August 2022

  • Fri 5

    Grand Rounds August 5: Economic Evaluation of Platform Trial Designs (Jay JH Park, PhD, MSc)

    August 5, 2022 @ 1:00 pm - 2:00 pm

    Speaker: Jay JH Park, PhD, MSc Assistant Professor Department of Health Research Methods, Evidence and Impact Faculty of Health Sciences McMaster University Topic: Economic Evaluation of Platform Trial Designs Date: […]

  • Fri 12

    Grand Rounds August 12: Equitably Including Diverse Participants in Pragmatic Clinical Trials (Consuelo H. Wilkins, MD, MSCI)

    August 12, 2022 @ 1:00 pm - 2:00 pm

    Speaker: Consuelo H. Wilkins, MD, MSCI Senior Vice President and Senior Associate Dean for Health Equity and Inclusive Excellence Professor of Medicine Vanderbilt University Medical Center   Topic: Equitably Including […]

  • Fri 19

    Grand Rounds August 19: Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change (Gerald Bloomfield, MD, MPH; Michelle Kelsey, MD)

    August 19, 2022 @ 1:00 pm - 2:00 pm

    Speaker: Gerald Bloomfield, MD, MPH Associate Professor with Tenure, Medicine Associate Professor, Global Health Duke University Michelle Kelsey, MD Assistant Professor of Medicine Duke University School of Medicine   Topic: […]

  • Fri 26

    Grand Rounds August 26: The Diuretic Comparison Project: A Large Pragmatic Clinical Trial (Areef Ishani, MD, MS)

    August 26, 2022 @ 1:00 pm - 2:00 pm

    Speaker: Areef Ishani, MD MS Director, Primary Care and Specialty Medicine Service Line Minneapolis VA Health Care System Professor of Medicine University of Minnesota Topic: The Diuretic Comparison Project: A Large Pragmatic Clinical Trial Date: Friday, August 26, 2022, 1:00-2:00 p.m. ET   Meeting Info: To check whether you have the appropriate players installed for […]

  • September 2022

  • Fri 9

    Grand Rounds Ethics and Regulatory Series September 9: Building an Academic Learning Health System: Why Is It So Hard? (Steven Joffe, MD, MPH)

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

    Speaker: Steven Joffe, MD, MPH Art and Ilene Penn Professor and Chair Department of Medical Ethics & Health Policy University of Pennsylvania Perelman School of Medicine Topic: Keynote: Building an Academic Learning Health System: Why Is It So Hard? Date: Friday, September 9, 2022, 1:00-2:00 p.m. ET   Meeting Info: To check whether you have […]

  • Fri 16

    Grand Rounds September 16: Using Nationwide Registries to Conduct Pragmatic Randomized Trials: The DANFLU Program (Tor Biering-Sørensen, MD, PhD, MPH)

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

    Speaker: Tor Biering-Sørensen, MD, PhD, MPH Professor in Translational Cardiology and Pragmatic Randomized Trials Head of Center for Translational Cardiology and Pragmatic Randomized Trials Department of Biomedical Sciences Faculty of Health and Medical Sciences University of Copenhagen Head of Cardiovascular Non-Invasive Imaging Research Laboratory Department of Cardiology Copenhagen University Hospital - Herlev and Gentofte Topic: Using […]

  • Fri 23

    Grand Rounds September 23: Effect Of An Intensive Nurse Home Visiting Program On Adverse Birth Outcomes In A Medicaid-Eligible Population (Margaret McConnell, PhD)

    September 23, 2022 @ 1:00 pm - 2:00 pm

    Speaker: Margaret McConnell, PhD Associate Professor Harvard T.H. Chan School of Public Health Topic: Effect Of An Intensive Nurse Home Visiting Program On Adverse Birth Outcomes In A Medicaid-Eligible Population Date: Friday, September 23, 2022, 1:00-2:00 p.m. ET   Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) […]

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