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Living Textbook of
Pragmatic Clinical Trials

COVID-19 Resources

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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  • May 2020

  • Fri 29

    Grand Rounds EHR Workshop Series May 29: Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Experiences from the Collaboratory PCTs

    May 29, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Guest Moderator Wendy Weber, ND, PhD, MPH Branch Chief, Clinical Research in Complementary and Integrative Health Division of Extramural Research National Center for Complementary and Integrative Health, NIH Panel […]

  • June 2020

  • Fri 5

    Grand Rounds June 5: PCORnet COVID-19 Common Data Model Design and Results

    June 5, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Thomas W. Carton, PhD, MS Chief Data Officer Louisiana Public Health Institute Keith Marsolo, PhD Associate Professor Department of Population Health Sciences Duke Clinical Research Institute Duke University School […]

  • Fri 12

    Grand Rounds June 12: A Cluster Randomized Pragmatic Trial of an Advance Care Planning Video Intervention in Long-Stay Nursing Home Residents: Main Findings from the PROVEN Trial

    June 12, 2020 @ 1:00 pm - 2:00 pm

    Speaker: Susan L. Mitchell MD, MPH Senior Scientist Hebrew SeniorLife Hinda and Arthur Marcus Institute for Aging Research Professor of Medicine Harvard Medical School Topic: A Cluster Randomized Pragmatic Trial […]

  • Fri 19

    Living Textbook Grand Rounds Series June 19: Part 4-Demystifying Biostatistical Concepts for Embedded Pragmatic Clinical Trials

    June 19, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Elizabeth Turner, PhD Associate Professor Department of Biostatistics & Bioinformatics and Duke Global Health Institute Duke University Patrick Heagerty, PhD Professor Department of Biostatistics University of Washington David Murray, […]

  • Fri 26

    Grand Rounds EHR Workshop Series June 26: Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Keys to Success in the Evolving EHR Environment

    June 26, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Guest Moderator Keith Marsolo, PhD Associate Professor, Population Health Sciences Duke University Panel Teresa Zayas-Cabán, PhD Chief Scientist Office of the National Coordinator for Health Information Technology Office of […]

  • July 2020

  • Fri 3

    Grand Rounds July 3: No Presentation (Independence Day Holiday)

    July 3, 2020 @ 1:00 pm - 2:00 pm
  • Fri 10

    Grand Rounds July 10: COVID Open Science Collaborative Analytics Platform: National COVID Cohort Collaborative (N3C)

    July 10, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Ken Gersing, MD Director of Informatics, NCATS National Institutes of Health Robert A. Star, MD Director, Division of Kidney, Urologic, and Hematologic Disorders, NIDDK Chief, Renal Diagnostics and Therapeutics […]

  • Tue 14

    Methods: Mind the Gap Webinar July 14: Overview of Statistical Models for the Design and Analysis of Stepped Wedge Cluster Randomized Trials

    July 14, 2020 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker:  Fan Li, PhD Yale University School of Public Health Description: The stepped-wedge cluster randomized design has received increasing attention in pragmatic clinical trials (PCTs) and implementation science research. Since […]

  • Thu 16

    IMPACT Collaboratory Grand Rounds July 16: Breaking the Cycle: Health Care Systems Interactions for Impactful Results

    July 16, 2020 @ 12:00 pm - 1:00 pm

    Speakers:  Leah Hanson, PhD Senior Research Investigator, Senior Director of Research at HealthPartners Neuroscience Center, Health Partners Institute Co-Director of Research, HealthPartners Center for Memory and Aging Eric Larson, MD, […]

  • Fri 17

    Living Textbook Grand Rounds Series July 17: Part 5-Choosing What to Measure and Making it Happen: Your Keys to Pragmatic Trial Success

    July 17, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Rachel Richesson, PhD, MPH Associate Professor, Informatics Duke University School of Nursing Devon Check, PhD Assistant Professor, Population Health Sciences Department of Population Health Topic: Part 5-Choosing What to […]

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