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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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  • December 2022

  • 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 […]

  • Fri 13

    Grand Rounds Ethics and Regulatory Series January 13: Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials (Emily A. Largent, JD, PhD, RN)

    January 13, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Emily A. Largent, JD, PhD, RN Emanuel & Robert Hart Assistant Professor of Medical Ethics and Health Policy Department of Medical Ethics and Health Policy University of Pennsylvania Perelman […]

  • Fri 20

    Grand Rounds January 20, 2023: Collaborative Pragmatic Trials in Action: EVOLVE-MI (Mikhail Kosiborod, MD)

    January 20, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Mikhail Kosiborod, MD Vice President of Research Saint Luke’s Health System Professor of Medicine University of Missouri-Kansas City Topic: Collaborative Pragmatic Trials in Action: EVOLVE-MI Date: Friday, January 20, […]

  • Fri 27

    Grand Rounds January 27, 2023: The PREPARE II Trial: Embedding a Pragmatic Trial Into Clinical Care During an Emergency Procedure (Derek W. Russell, MD; Matthew W. Semler, MD, MSc)

    January 27, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Derek W. Russell, MD Assistant Professor, Department of Medicine Co-Director, Program in Medical ICU Research Division of Pulmonary, Allergy & Critical Care Medicine Assistant Medical Director, Birmingham Veterans Affairs Medical Center MICU University of Alabama at Birmingham Heersink […]

  • February 2023

  • Fri 3

    Grand Rounds February 3, 2023: Pragmatic Trials For Children With Congenital Heart Disease: Insights From The NITRIC Trial (Luregn Schlapbach, PhD, FCICM)

    February 3, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Prof Luregn Schlapbach, PhD, FCICM Head, Department of Intensive Care and Neonatology University Children`s Hospital, Zurich Zurich, Switzerland The University of Queensland Brisbane, Australia Topic: Pragmatic Trials For Children […]

  • Fri 10

    Grand Rounds Ethics and Regulatory Series February 10: Informing and Consenting: What Are the Goals? (P. Pearl O’Rourke, MD; David S. Wendler, PhD, MA; Miguel Vazquez, MD; P. Michael Ho, MD, PhD)

    February 10, 2023 @ 1:00 pm - 2:00 pm

    Speaker: P. Pearl O'Rourke, MD (retired) Harvard Medical School David S. Wendler, PhD, MA Senior Researcher Head, Section on Research Ethics Department of Bioethics NIH Clinical Center Miguel Vazquez, MD […]

  • Fri 17

    Grand Rounds February 17, 2023: The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials (Michael Gibson, MS, MD)

    February 17, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Michael Gibson, M.S., M.D. Professor of Medicine Harvard Interventional Cardiologist BI Lahey CEO & President of the non-Profit Baim Institute for Clinical Research & PERFUSE Study Group Topic: The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials Date: Friday, February 17, 2023, 1:00-2:00 p.m. ET To join the online meeting: Click the […]

  • Fri 24

    Grand Rounds February 24, 2023: S2302 Pragmatica-Lung: New Directions for Decreasing Burden and Increasing Inclusion in NCTN Clinical Trials (Konstantin Dragnev, MD; Karen Reckamp, MD, MS)

    February 24, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Konstantin Dragnev, MD Professor of Medicine, Hematology/Oncology Irene Heinz Given Professor in Pharmacology Associate Director for Clinical Research Principal Investigator – Dartmouth Lead Academic Participating Site for NCTN Dartmouth Cancer Center Dartmouth Health Karen Reckamp, MD, MS Director, Division of Medical Oncology Associate Director, Clinical Research Clinical Professor, Department of Medicine Topic: S2302 Pragmatica-Lung: […]

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