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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.

Events

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  • January 2023

  • 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 School of Medicine Matthew W. Semler, MD, MSc Assistant Professor of Medicine and Biomedical Informatics Medical Director, Center for Learning Healthcare, Vanderbilt Institute for Clinical […]

  • 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 With Congenital Heart Disease: Insights From The NITRIC Trial Date: Friday, February 3, 2023, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom […]

  • 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 Professor of Internal Medicine UT Southwestern Medical Center P. Michael Ho, MD, PhD Professor of Medicine University of Colorado School of Medicine Topic: Informing and […]

  • 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 […]

  • 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 […]

  • March 2023

  • Fri 3

    Grand Rounds March 3, 2023: Adoption, Implementation and Sustainment of Family-focused Prevention in Health Care Systems: How Do We Get There? (Margaret Kuklinski, PhD; Stacy Sterling, DrPH, MSW)

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

    Speaker: Margaret Kuklinski, PhD Endowed Associate Professor of Prevention in Social Work Director, Social Development Research Group Acting Director, Center for Communities That Care School of Social Work, University of […]

  • Fri 10

    Grand Rounds March 10, 2023: Estimands in Cluster-Randomized Trials: Choosing Analyses that Answer the Right Question (Brennan Kahan, PhD)

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

    Speaker: Brennan Kahan, PhD MRC Clinical Trials Unit University College London (UCL) Topic: Estimands in Cluster-Randomized Trials: Choosing Analyses that Answer the Right Question Date: Friday, March 10, 2023, 1:00-2:00 […]

  • Fri 17

    Grand Rounds March 17, 2023: Patient-Reported Outcomes for Symptom and Adverse Event Monitoring in Oncology (Ethan Basch, MD, MSc)

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

    Speaker: Ethan Basch, MD, MSc Professor and Chief of Oncology University of North Carolina Topic: Patient-Reported Outcomes for Symptom and Adverse Event Monitoring in Oncology Date: Friday, March 17, 2023, […]

  • Fri 24

    Grand Rounds March 24, 2023: From Observational Studies to Pragmatic Clinical Trials: (Almost) A Decade of Research in PCORnet® (Erin Holve, PhD, MPH, MPP; Russell Rothman, MD, MPP; Schuyler Jones, MD; Neha Pagidipati, MD, MPH)

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

    Speaker: Erin Holve, PhD, MPH, MPP Chief Research Infrastructure Officer, Patient-Centered Outcomes Research Institute (PCORI) Russell Rothman. MD, MPP Director Institute for Medicine and Public Health and Senior Vice President, […]

  • Fri 31

    Grand Rounds March 31, 2023: Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension (QUARTET USA): Results From A Randomized Controlled Trial (Jody D. Ciolino, PhD)

    March 31, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Jody D. Ciolino, PhD Associate Professor Director, Master of Science in Biostatistics Department of Preventive Medicine – Biostatistics Biostatistics Collaboration Center (BCC) / Northwestern University Data Analysis and Coordinating […]

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