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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 2018

  • Fri 7

    Grand Rounds September 7: NIH Collaboratory: Research Transformation in Progress

    September 7, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Adrian F. Hernandez, MD, MHS Professor of Medicine Vice Dean for Clinical Research Duke University School of Medicine Kevin Weinfurt, PhD Professor and Vice Chair for Research Department of […]

  • Fri 14

    Grand Rounds September 14: Advancing the Use of Mobile Technologies for Data Capture & Improved Clinical Trials

    September 14, 2018 @ 1:00 pm - 2:00 pm

    Speakers: John Hubbard, Ph.D., FCP Strategic Advisory Board, Genstar Capital Barry Peterson, Ph.D Independent Consultant Cheryl A. Grandinetti, Pharm.D. Office of Compliance, Office of Scientific Investigations, Division of Clinical Compliance […]

  • Fri 21

    Grand Rounds September 21: Returning Individual Research Results to Participants: Guidance for a New Research Paradigm

    September 21, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Jeffrey R. Botkin, M.D., M.P.H. Associate Vice President for Research Professor of Pediatrics University of Utah School of Medicine Consuelo H. Wilkins, M.D., MSCI Associate Professor of Medicine Vanderbilt […]

  • Fri 28

    Grand Rounds September 28: Assessing and reducing risk of re-identification when sharing sensitive research datasets

    September 28, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Gregory Simon MD, MPH Investigator Kaiser Permanente Washington Health Research Institute Deven McGraw, JD, MPH, LLM General Counsel & Chief Regulatory Officer Ciitizen (former HIPAA Deputy Director, HHS Office […]

  • October 2018

  • Fri 5

    Grand Rounds October 5: Testing New Atrial Fibrillation Screening Methods at Scale

    October 5, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Mintu Turakhia MD, MAS Associate Professor of Medicine. Stanford University Executive Director, Stanford Center for Digital Health Director of Cardiac Electrophysiology, VA Palo Alto Healthcare System Marco Perez MD […]

  • Fri 12

    Grand Rounds October 12: MDEpiNet RAPID and SPEED Projects: Leveraging Real World Evidence to Get Better, Faster, Cheaper Medical Devices for Physicians and Patients

    October 12, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Renee Mitchell, MT(ASCP), CLS(NCA) Regulatory Affairs Boston Scientific Corporation, Inc. Terrie Reed, MSIE Senior Advisor for UDI Adoption US Food and Drug Administration (FDA) Roseann White, MA Director of […]

  • Fri 19

    Grand Rounds October 19: A New Path Forward for Using Decentralized Clinical Trials

    October 19, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Annemarie Forrest Clinical Trials Transformation Initiative (CTTI) Penny Randall, MD, MBA VP and Global Therapeutic Head, CNS, IQVIA Jeffry Florian, PhD Clinical Analyst, Office of New Drugs, FDA CDER […]

  • Fri 26

    Grand Rounds October 26: Making Measurements Meaningful

    October 26, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Brian J. Zikmund-Fisher, Ph.D. Associate Professor of Health Behavior and Health Education University of Michigan Associate Director of the UM Center for Bioethics and Social Sciences in Medicine Topic: […]

  • November 2018

  • Fri 2

    Grand Rounds November 2: EMBED: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder

    November 2, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Ted Melnick, MD, MHS Assistant Professor of Emergency Medicine Program Director, ACGME Clinical Informatics Fellowship Yale School of Medicine Gail D’Onofrio, MD Professor and Chair of Emergency Medicine, Yale […]

  • Tue 6

    DCRI Research Forum: Dr. Jeffrey Jarvik on Lumbar Imaging with Reporting of Epidemiology (LIRE)

    November 6, 2018 @ 12:00 pm - 1:00 pm

    DCRI Research Forum  Dr. Jeffrey Jarvik on Lumbar Imaging with Reporting of Epidemiology (LIRE)  12:00 pm | Eastern Daylight Time (New York, GMT-04:00) | 1 hr. Meeting number (access code): 732 […]

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