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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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  • September 2019

  • Fri 6

    Grand Rounds September 6: Transforming Medical Evidence Generation with Technology-Enabled Trials

    September 6, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Matthew T. Roe, MD, MHS Senior Investigator, Professor of Medicine Duke Clinical Research Institute Topic: Transforming Medical Evidence Generation with Technology-Enabled Trials Date: Friday, September 6, 2019, 1:00-2:00 p.m. […]

  • Fri 13

    Grand Rounds September 13: ADAPTABLE Recruitment and Follow-up: Health Plan Research Network Engagement

    September 13, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Kevin Haynes, PharmD, MSCE Principal Scientist HealthCore, Inc. Topic: ADAPTABLE Recruitment and Follow-up: Health Plan Research Network Engagement Date: Friday, September 13, 2019, 1:00-2:00 p.m. ET Meeting Info: To […]

  • Fri 20

    Grand Rounds September 20: Designing & Testing the Future of Home-based Cervical Cancer Screening: Results from a Collaborative Academic-Embedded Delivery System Pragmatic Randomized Trial

    September 20, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Rachel L. Winer, PhD University of Washington School of Public Health Department of Epidemiology Diana S.M. Buist, PhD, MPH Kaiser Permanente Washington Health Research Institute Topic: Designing & testing […]

  • Fri 27

    Grand Rounds September 27: Preparing for Clinical Trial Data Sharing and Re-use: The New Reality for Researchers

    September 27, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Rebecca Li, PhD Executive Director, Vivli Co-Director of Research Ethics, Harvard Center for Bioethics Harvard Medical School Frank W. Rockhold, PhD Professor of Biostatistics and Bioinformatics Duke Clinical Research […]

  • October 2019

  • Fri 4

    Grand Rounds October 4: Ascertaining Death and Hospitalization Endpoints: The TRANSFORM-HF Experience

    October 4, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Eric L. Eisenstein, DBA Associate Professor in Medicine Duke University School of Medicine Kevin J. Anstrom, PhD Professor of Biostatistics and Bioinformatics Director of Biostatistics, Duke Clinical Research Institute […]

  • Fri 11

    Grand Rounds October 11: Objecting to Experiments that Compare Two Unobjectionable Policies or Treatments: Implications for Comparative Effectiveness and Other Pragmatic Clinical Trials

    October 11, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Michelle N. Meyer, PhD, JD Assistant Professor & Associate Director, Research Ethics Center for Translational Bioethics & Health Care Policy Faculty Co-Director, Behavioral Insights Team Steele Institute for Health Innovation, Geisinger Topic: Objecting to Experiments that Compare Two Unobjectionable Policies or Treatments: Implications for Comparative Effectiveness and Other Pragmatic Clinical Trials Date: Friday, October […]

  • Fri 18

    Grand Rounds October 18: Playing with FHIR–Innovative Use Cases for the New REDCap EHR Integration Module

    October 18, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Paul A. Harris, PhD Director, Professor of Biomedical Informatics Vanderbilt University Medical Center Topic: Playing with FHIR–Innovative Use Cases for the New REDCap EHR Integration Module Date: Friday, October 18, 2019, 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 […]

  • Fri 25

    Grand Rounds October 25: Real-World Evidence for Drug Effectiveness Evaluation: Addressing the Credibility Gap

    October 25, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Richard Willke, PhD Chief Science Officer, ISPOR Topic: Real-World Evidence for Drug Effectiveness Evaluation: Addressing the Credibility Gap Date: Friday, October 25, 2019, 1:00-2:00 p.m. ET Meeting Info: To […]

  • November 2019

  • Fri 1

    Grand Rounds November 1: NIH Collaboratory: Looking Back and Looking Forward

    November 1, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Adrian F. Hernandez, MD, MHS Professor of Medicine Vice Dean for Clinical Research Duke University, School of Medicine Lesley H. Curtis, PhD Chair and Professor Department of Population Health […]

  • Fri 8

    Grand Rounds November 8: Lumbar Imaging with Reporting of Epidemiology: Initial Results and Some Lessons Learned

    November 8, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Jeffrey (Jerry) G. Jarvik MD MPH Professor, Radiology, Neurological Surgery and Health Services Adjunct Professor, Pharmacy and Orthopedics & Sports Medicine University of Washington Patrick Heagerty, PhD Professor and […]

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