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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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  • April 2018

  • Fri 27

    Grand Rounds April 27: Expanding Use of Real-World Evidence, a National Academies Workshop Series (Greg Simon, MD, MPH)

    Featured April 27, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Greg Simon, MD, MPH Senior Investigator Kaiser Permanente Washington Health Research Institute Topic: Expanding Use of Real-World Evidence, a National Academies Workshop Series Date: Friday, April 27, 2018, 1:00-2:00 […]

  • May 2018

  • Fri 4

    Grand Rounds May 4: Leveraging Community Engagement and Informatics-Based Tools to Increase Participant Recruitment and Retention (Paul A. Harris, PhD; Consuelo H. Wilkins, MD, MSCI; Patricia Jones, DrPH, MPH)

    Featured May 4, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Paul A. Harris, PhD Director, Office of Research Informatics Professor, Department of Biomedical Informatics & Department of Biomedical Engineering Vanderbilt University Consuelo H. Wilkins, MD, MSCI Executive Director, Meharry-Vanderbilt […]

  • Wed 9

    Advancing the Science of Patient Input in Medical Product R&D: Towards A Research Agenda

    Featured May 9, 2018 @ 8:30 am - 5:00 pm

    About This Webcast  Converting traditionally anecdotal patient input into rigorous, credible evidence for use by a broad range of stakeholders could better align medical product research and development (R&D) and […]

  • Fri 11

    Grand Rounds May 11: Launching the NESTcc Data Network to Improve the use of Real-World Evidence in the Medical Device Ecosystem (Rachael Fleurence, PhD)

    Featured May 11, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Rachael Fleurence, PhD Executive Director, National Evaluation System for health Technology Coordinating Center (NESTcc) Medical Device Innovation Consortium (MDIC) Topic: Launching the NESTcc Data Network to Improve the use […]

  • 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 […]

  • 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 […]

  • 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 […]

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