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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
10 events found.

Events

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  • August 2022

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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, […]

  • 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 […]

  • 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 […]

  • 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 […]

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