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Living Textbook of
Pragmatic Clinical Trials

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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
23 events found.

Events

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  • 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: Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change Date: Friday, August 19, 2022, 1:00-2:00 p.m. ET   Meeting Info: To check […]

  • 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) […]

  • Fri 30

    Grand Rounds September 30: CTTI’s Digital Health Trials Hub: Multi-Stakeholder Resources to Conduct Effective Digital Health Trials (Marianne Chase; Jörg Goldhahn, MD)

    September 30, 2022 @ 1:00 pm - 2:00 pm

    Speaker: Marianne Chase Senior Director Clinical Trial Operations Neurological Clinical Research Institute Massachusetts General Hospital Jörg Goldhahn, MD Medical Director Director of Institute for Translational Medicine ETH Zurich Topic: CTTI’s Digital Health Trials Hub: Multi-Stakeholder Resources to Conduct Effective Digital Health Trials Date: Friday, September 30, 2022, 1:00-2:00 p.m. ET   Meeting Info: To check […]

  • October 2022

  • Fri 7

    Grand Rounds October 7: Impact Of Handovers Of Anesthesia Care On Morbidity And Mortality (Melanie Meersch-Dini, MD)

    October 7, 2022 @ 1:00 pm - 2:00 pm

    Speaker: Melanie Meersch-Dini, MD Professor Department of Anesthesiology, Intensive Care and Pain Medicine University Hospital Münster, Germany Topic: Impact Of Handovers Of Anesthesia Care On Morbidity And Mortality Date: Friday, October 7, 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 […]

  • Fri 14

    Grand Rounds Ethics and Regulatory Series October 14: Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials (Joseph Ali, JD; Leslie J. Crofford, MD; Tanya Matthews, PhD)

    October 14, 2022 @ 1:00 pm - 2:00 pm

    Speaker: Joseph Ali, JD Assistant Professor, Dept. of International Health Johns Hopkins Bloomberg School of Public Health Core Faculty & Associate Director for Global Programs Johns Hopkins Berman Institute of Bioethics Tanya Matthews, PhD HRPP Director Kaiser Permanente Washington Leslie J. Crofford, MD Wilson Family Chair in Medicine Professor of Medicine and Pathology, Microbiology & […]

  • 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 Sciences in Medicine Assistant Professor of Obstetrics & Gynecology University of Michigan Medical School Topic: Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst […]

  • 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 18, 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, […]

  • 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: Lessons Learned Date: Friday, December 2, 2022, 1:00-2:00 p.m. ET   Meeting Info: To check whether you have the appropriate players installed for UCF (Universal […]

  • 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 Medicine and Biomedical Ethics and Professor of Pediatrics, Medicine, and by courtesy of Bioengineering Director, Stanford Center for Biomedical Ethics Associate Dean for Research Topic: […]

  • 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 - The Feinstein Institutes for Medical Research System Director – Anticoagulation and Clinical Thrombosis Services Northwell Health at Lenox Hill Hospital Jeffrey Solomon, BFA Senior Director, […]

  • 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 Obesity Medicine University of Minnesota Medical School Thomas Murray, PhD Division of Biostatistics Coordinating Centers for Biometric Research University of Minnesota School of Public Health […]

  • 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 School of Medicine Topic: Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials Date: Friday, January 13, 2023, 1:00-2:00 p.m. ET   To join […]

  • 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, 2023, 1:00-2:00 pm ET To join the online meeting: Click the Zoom Meeting link below: https://duke.zoom.us/j/96153659804?pwd=VmNJVDE5VmtFbUFHY0lZeTM1K0Y5QT09 Meeting ID: 961 5365 9804 Passcode: 12345 One tap […]

  • 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 […]

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