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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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  • 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. […]

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