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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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  • May 2018

  • Wed 16

    Embedded Pragmatic Clinical Trials of Therapeutic A vs. B Interventions Workshop

    Featured May 16, 2018 @ 8:00 am - 4:15 pm

      About This Event  Organizing Committee: Adrian Hernandez & Richard Platt (Co-Chairs), Laura Dember, Leslie Derr, Susan Huang, Catherine Meyers, Wendy Weber and Dave Wendler This one-day workshop will explore challenges and strategies for planning and implementing embedded pragmatic clinical trials (PCT) that compare two or more therapeutic medical regimens. Pragmatic trials differ from traditional […]

  • Fri 18

    Grand Rounds May 18: The PCORnet Antibiotics and Childhood Growth Study: Using PCORnet Data for Longitudinal Observational Research (Christopher Forrest, MD, PhD; L. Charles Bailey, MD, PhD; Jason Block, MD, MPH)

    Featured May 18, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Christopher B. Forrest, MD, PhD Professor, Pediatrics & Health Care Management PI, PEDSnet, A National Pediatric Learning Health System Director, Center for Applied Clinical Research, Children's Hospital of Philadelphia and University of Pennsylvania L. Charles Bailey, MD, PhD Associate Professor of Clinical Pediatrics Perelman School of Medicine Children's Hospital of Philadelphia and University of […]

  • June 2018

  • Fri 1

    Grand Rounds June 1: How Would You Build an Academic Medical System to Bridge Research and Care if You Could Start from Scratch? (S. Claiborne “Clay” Johnston, MD, PhD, MPH)

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

    Speakers: S. Claiborne “Clay” Johnston, MD, PhD, MPH Dean and Vice President for Medical Affairs Dell Medical School, The University of Texas at Austin Topic: How Would You Build an […]

  • Fri 8

    Grand Rounds June 8: Implementation in the PROVEN Trial: Challenges of Conducting PCTs in Nursing Home Health Care Systems (Susan Mitchell MD, MPH; Angelo Volandes, MD, MPH)

    Featured June 8, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Susan Mitchell, MD, MPH Senior Scientist, Institute for Aging Research, Hebrew Senior Life Professor of Medicine, Harvard Medical School Angelo Volandes, MD, MPH Associate Professor of Medicine, Harvard Medical […]

  • Fri 15

    Grand Rounds June 15: Research at Scale – Exploring What is Possible with High-Quality Real-World Data. Examples from Flatiron Health. (Amy P. Abernethy, MD, PhD)

    Featured June 15, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Amy P. Abernethy, MD, PhD Chief Medical Officer, Chief Scientific Officer, SVP Oncology Flatiron Health Topic: Research at Scale - Exploring What is Possible with High-Quality Real-World Data. Examples […]

  • Fri 22

    Grand Rounds June 22: Pragmatic Trial Design to Study Health Policy Interventions: Lessons Learned from ARTEMIS (Tracy Y. Wang, MD, MHS, MSc)

    June 22, 2018 @ 1:00 pm - 2:00 pm

    Speaker: Tracy Y. Wang, MD, MHS, MSc Director, DCRI Health Service Research Fellowship Associate Program Director Associate Professor of Medicine, Cardiology Duke University Medical Center Topic: Pragmatic Trial Design to Study […]

  • Fri 29

    Grand Rounds June 29: Policy & Priorities: Rethinking University Research with State Data (Aaron McKethan, PhD)

    June 29, 2018 @ 1:00 pm - 2:00 pm

    Speaker: Aaron McKethan, PhD Assistant Professor of Population Health Sciences, Duke School of Medicine Senior Policy Fellow, Duke-Margolis Center for Health Policy Chief Data Officer, NC DHHS Topic: Policy & […]

  • July 2018

  • Fri 6

    Grand Rounds July 6th: No Presentation (Week of July 4th Holiday)

    July 6, 2018 @ 1:00 pm - 2:00 pm

    Grand Rounds July 6th: No Presentation (In observance of July 4th holiday) We hope to see you next week.

  • Tue 10

    Report Release Webinar: Returning Individual Research Results to Participants

    July 10, 2018 @ 11:00 am - 12:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Register now! Report release for Returning Individual Research Results to Participants When is it appropriate to return individual research results to participants? What are the risks and benefits of the practice […]

  • Wed 11

    Mind The Gap NIH Webinar Series: Stepped Wedge Cluster Randomized Designs for Disease Prevention Research

    July 11, 2018 @ 11:00 am - 12:00 pm

    About This Webinar  The stepped wedge cluster randomized design has seen a rapid increase in popularity over the past decade. It is different than the conventional parallel arm cluster randomized […]

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