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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.

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  • March 2018

  • Fri 23

    Grand Rounds March 23: Data Science in the Era of Data Ubiquity (Robert M. Califf, MD)

    Featured March 23, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Robert M. Califf, MD Vice Chancellor for Health Data Science Duke University Advisor, Verily Life Sciences Topic: Data Science in the Era of Data Ubiquity Date: Friday, March 23, 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 […]

  • Fri 30

    Grand Rounds March 30: HHS-DoD-VA Pain Management Collaboratory (Robert Kerns, PhD)

    Featured March 30, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Robert D. Kerns, PhD Professor of Psychiatry, Neurology, and Psychology Yale University Topic: HHS-DoD-VA Pain Management Collaboratory Date: Friday, March 30, 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 join the online meeting: Go to […]

  • April 2018

  • Fri 6

    Grand Rounds April 6: Legal and Ethical Architecture for PCOR Data (Jane Hyatt Thorpe, JD; Lara Cartwright-Smith, JD, MPH; Elizabeth Gray, JD, MHA)

    Featured April 6, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Jane Hyatt Thorpe, JD Associate Professor Department of Health Policy and Management Milken Institute School of Public Health George Washington University Lara Cartwright-Smith, JD, MPH Associate Research Professor Department of Health Policy and Management Milken Institute School of Public Health George Washington University Elizabeth Gray, JD, MHA Research Scientist Department of Health Policy and […]

  • Fri 13

    Grand Rounds April 13: OHDSI: Drawing Reproducible Conclusions from Observational Clinical Data (George Hripcsak, MD, MS)

    Featured April 13, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: George Hripcsak, MD, MS Vivian Beaumont Allen Professor of Biomedical Informatics, Columbia University Chair, Department of Biomedical Informatics, Columbia University Director, Medical Informatics Services, NewYork-Presbyterian Hospital/Columbia Topic: OHDSI: Drawing Reproducible Conclusions from Observational Clinical Data Date: Friday, April 13, 2018, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF […]

  • Fri 20

    Grand Rounds April 20: The Trauma Survivors Outcomes and Support (TSOS) Trial as an ePCT Training Case Study (Doug Zatzick, MD)

    Featured April 20, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Doug Zatzick, MD TSOS Principal Investigator Professor, Department of Psychiatry and Behavioral Sciences University of Washington School of Medicine Topic: The Trauma Survivors Outcomes and Support (TSOS) Trial as an ePCT Training Case Study Date: Friday, April 20, 2018, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for […]

  • 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 […]

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