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Living Textbook of
Pragmatic Clinical Trials

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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.

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  • June 2022

  • Thu 16

    NIH Pragmatic Trials Collaboratory 2022 Annual Workshop Critical Questions for Pragmatic Clinical Trialists: Insights From the NIH Pragmatic Trials Collaboratory’s First Decade

    June 16, 2022 @ 1:00 pm - 5:00 pm

    The NIH Pragmatic Trials Collaboratory will hold a virtual workshop June 15-16, 2022, to explore questions critical to designing and implementing pragmatic clinical trials conducted within healthcare systems. This workshop […]

  • Fri 17

    Grand Rounds June 17: PREPARE: A Successful, Primarily Remote Pragmatic Trial in a Black and Latinx Population With Asthma: Challenges and Successes (Elliot Israel, MD)

    June 17, 2022 @ 1:00 pm - 2:00 pm

    Speaker: Elliot Israel, M.D. Professor of Medicine Harvard Medical School Gloria M. and Anthony C. Simboli Distinguished Chair in Asthma Research Director of Clinical Research Pulmonary and Critical Care Division […]

  • Fri 24

    Grand Rounds June 24: FDA Draft Guidance on Real-World Evidence (John Concato, MD, MS, MPH)

    June 24, 2022 @ 1:00 pm - 2:00 pm

    Speaker: John Concato, MD, MS, MPH Associate Director for Real-World Evidence Analytics Office of Medical Policy (OMP) Center for Drug Evaluation and Research (CDER) Food and Drug Administration (FDA) Topic: […]

  • July 2022

  • Fri 8

    Grand Rounds July 8: Results From the COVID-OUT Trial, a Phase-3 Trial of Outpatient Treatment for COVID-19 Using Metformin, Ivermectin, and Fluvoxamine (Carolyn Bramante, MD, MPH; Thomas Murray, PhD; Jaren Huling, PhD)

    July 8, 2022 @ 1:00 pm - 2:00 pm

    Speakers: Carolyn Bramante, MD, MPH Assistant Professor, General Internal Medicine and Pediatrics Core Faculty, Center for Pediatric Obesity Medicine Core Faculty, Program for Health Disparities Research University of Minnesota Medical […]

  • 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: […]

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