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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

  • Tue 24

    NIH Mind the Gap Webinar: Design and Analysis of Individually Randomized Group-Treatment Trials in Public Health

    Featured April 24, 2018 @ 11:00 am - 12:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker Sherri Pals, PhD. Mathematical Statistician at the Centers for Disease Control and Prevention (CDC). Dr. Pals will accept questions during the webinar via WebEx and Twitter. Use the hashtag #NIHMtG. About This Webinar Individually randomized group-treatment (IRGT) trials are studies in which individual participants are randomly assigned to study conditions, but treatment is administered in […]

  • 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 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. To […]

  • 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 Alliance Patricia Jones, DrPH, MPH Program Director National Center for Advancing Translational Sciences (NCATS) Topic: Leveraging Community Engagement and Informatics-Based Tools to Increase Participant Recruitment […]

  • 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 regulatory decision-making with patient experience of and preferences for disease management and treatment. Accordingly, many efforts have been launched to advance a science of patient input—the […]

  • 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 of Real-World Evidence in the Medical Device Ecosystem Date: Friday, May 11, 2018, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate […]

  • 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 Academic Medical System to Bridge Research and Care if You Could Start from Scratch? Date: Friday, June 1, 2018, 1:00-2:00 p.m. ET Meeting Info: To […]

  • 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 School Division of General Internal Medicine, Mass General Hospital Topic: Implementation in the PROVEN Trial: Challenges of Conducting PCTs in Nursing Home Health Care Systems […]

  • 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 from Flatiron Health. Date: Friday, June 15, 2018, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF (Universal […]

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