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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
    • 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
25 events found.

Events

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  • June 2019

  • Fri 28

    Grand Rounds June 28: Moving Beyond Return of Research Results to Return of Value

    June 28, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Consuelo H. Wilkins, MD, MSCI Vice President for Health Equity, Vanderbilt University Medical Center Executive Director, Meharry-Vanderbilt Alliance Topic: Moving Beyond Return of Research Results to Return of Value Date: Friday, June 28, 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 […]

  • July 2019

  • Fri 5

    Grand Rounds July 5: No Presentation (Independence Day Holiday)

    July 5, 2019 @ 1:00 pm - 2:00 pm
  • Fri 12

    Grand Rounds July 12: medRxiv: A Paradigm Shift in Disseminating Clinical and Public Health Research

    July 12, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Harlan M. Krumholz, MD, SM Harold H. Hines, Jr. Professor of Medicine and Public Health Yale University Joseph S. Ross, MD, MHS Associate Professor of Medicine and Public Health Yale University Topic: medRxiv: A Paradigm Shift in Disseminating Clinical and Public Health Research Date: Friday, July 12, 2019, 1:00-2:00 p.m. ET Meeting Info: To […]

  • Fri 19

    Grand Rounds July 19: Misinformation as a Source of Complication for Clinical Trials

    July 19, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Brian Southwell, PhD Senior Director, Science in the Public Sphere, RTI International Duke-RTI Scholar, Duke Forge, Duke University Topic: Misinformation as a Source of Complication for Clinical Trials Date: Friday, July 19, 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 to […]

  • Fri 26

    Grand Rounds July 26: Digital in Trials: Improving Participation and Enabling Novel Endpoints

    July 26, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Craig H. Lipset Former Head of Clinical Innovation Pfizer Topic: Digital in Trials: Improving Participation and Enabling Novel Endpoints Date: Friday, July 26, 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 to https://dukemed.webex.com/dukemed/systemdiagnosis.php. To join the online meeting: […]

  • August 2019

  • Fri 2

    Grand Rounds August 2, 2019: AI and the Future of Psychiatry

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

    Speaker: Murali Doraiswamy Professor of Psychiatry and Behavioral Sciences Duke School of Medicine Topic: AI and the Future of Psychiatry Date: Friday, August 2, 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 to https://dukemed.webex.com/dukemed/systemdiagnosis.php. To join the online meeting: […]

  • Fri 9

    Grand Rounds August 9: Open Science: Are we there yet?

    August 9, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Adrian Hernandez, MD Professor of Medicine Vice Dean for Clinical Research Duke University, School of Medicine Topic: Open Science: Are we there yet? Date: Friday, August 9, 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 to https://dukemed.webex.com/dukemed/systemdiagnosis.php. To […]

  • Fri 16

    Grand Rounds August 16: Introducing the Digital Medicine Society (DiMe)

    August 16, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Andy Coravos CEO, Elektra Labs Fellow, Harvard-MIT Center for Regulatory Science Co-founder, Digital Medicine Society (DiMe) Jen Goldsack Interim Executive Director, DiMe Portfolio, Strategy & Ops, HealthMode Topic: Introducing the Digital Medicine Society (DiMe) Date: Friday, August 16, 2019, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for […]

  • Fri 23

    Grand Rounds August 23: Oh yes, we have tons of patients who can do this study!

    August 23, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Vanita R. Aroda, MD Director of Diabetes Clinical Research Brigham & Women’s Hospital Harvard Medical School Topic: Oh yes, we have tons of patients who can do this study! Date: Friday, August 23, 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 […]

  • Fri 30

    Grand Rounds August 30: No Presentation (Labor Day Holiday)

    August 30, 2019 @ 1:00 pm - 2:00 pm
  • 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 […]

  • 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 […]

  • 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 […]

  • Fri 15

    Grand Rounds November 15: PCORnet: Health Plan Research Network Data Linkage and Patient Engagement with Patient-Powered Research Networks

    November 15, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Kevin Haynes, PharmD, MSCE Principal Scientist HealthCore Topic: PCORnet: Health Plan Research Network Data Linkage and Patient Engagement with Patient-Powered Research Networks Date: Friday, November 15, 2019, 1:00-2:00 p.m. […]

  • Thu 21

    IMPACT Collaboratory: Are You Ready for a Pragmatic Trial? The RAPT Model and Implementation Considerations

    November 21, 2019 @ 12:00 pm - 1:00 pm

    Speakers: Rosa Baier, MPH Associate Director, Center for Long-Term Care Quality & Innovation Associate Professor, Health Sciences, Policy & Practice Brown University School of Medicine Eric Jutkowitz, PhD Assistant Professor Brown University School of Public Health Laura Gitlin, PhD, FGSA, FAAN Dean, Distinguished Professor, Drexel University Adjunt Professor, Johns Hopkins University Read more about the […]

  • Fri 22

    Grand Rounds November 22: It’s Time to Learn From Patients Like Mine

    November 22, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Nigam H Shah, MBBS, PhD Associate Professor of Medicine Stanford University Topic: It's Time to Learn From Patients Like Mine Date: Friday, November 22, 2019, 1:00-2:00 p.m. ET Meeting […]

  • Fri 29

    Grand Rounds November 29: No Presentation (Thanksgiving Holiday)

    November 29, 2019 @ 1:00 pm - 2:00 pm
  • December 2019

  • Fri 6

    Grand Rounds December 6: Millions More People, Stronger Collaborations: The New and Improved NIH Collaboratory Distributed Research Network

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

    Speakers: Richard Platt, MD, MS Professor and Chair Harvard Medical School Department of Population Medicine Kevin Haynes, PharmD, MSCE Principal Scientist HealthCore Denise Boudreau, PhD Senior Scientific Investigator Kaiser Permanente Washington Health Research Institute Jerry H. Gurwitz, MD Professor of Medicine, Family Medicine and Community Health, and Population & Quantitative Health Sciences University of Massachusetts […]

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