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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
11 events found.

Events

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  • June 2018

  • Fri 29

    Grand Rounds June 29: Policy & Priorities: Rethinking University Research with State Data (Aaron McKethan, PhD)

    June 29, 2018 @ 1:00 pm - 2:00 pm

    Speaker: Aaron McKethan, PhD Assistant Professor of Population Health Sciences, Duke School of Medicine Senior Policy Fellow, Duke-Margolis Center for Health Policy Chief Data Officer, NC DHHS Topic: Policy & […]

  • July 2018

  • Fri 6

    Grand Rounds July 6th: No Presentation (Week of July 4th Holiday)

    July 6, 2018 @ 1:00 pm - 2:00 pm

    Grand Rounds July 6th: No Presentation (In observance of July 4th holiday) We hope to see you next week.

  • Tue 10

    Report Release Webinar: Returning Individual Research Results to Participants

    July 10, 2018 @ 11:00 am - 12:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Register now! Report release for Returning Individual Research Results to Participants When is it appropriate to return individual research results to participants? What are the risks and benefits of the practice […]

  • Wed 11

    Mind The Gap NIH Webinar Series: Stepped Wedge Cluster Randomized Designs for Disease Prevention Research

    July 11, 2018 @ 11:00 am - 12:00 pm

    About This Webinar  The stepped wedge cluster randomized design has seen a rapid increase in popularity over the past decade. It is different than the conventional parallel arm cluster randomized […]

  • Fri 13

    Grand Rounds July 13: Clinical Trial Data Sharing: Perspectives from Participants and PCORI

    July 13, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Michelle M. Mello, JD, PhD Professor of Law, Stanford Law School Professor of Health Research and Policy, Stanford University School of Medicine Steven Goodman, MD, MHS, PhD Associate Dean, […]

  • Fri 20

    Grand Rounds July 20: Developing Technology-Derived Novel Endpoints for use in Clinical Trials: Recommendations and Case Examples from the Clinical Trials Transformation Initiative

    July 20, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Will Herrington, MA, MBBS, MD, MRCP MRC-Kidney Research UK Professor and David Kerr Clinician Scientist Nuffield Department of Population Health, University of Oxford Rob DiCicco, PharmD Principal Consultant TransCelerate […]

  • Fri 27

    Grand Rounds July 27: Pilot Study for a Pragmatic Trial Comparing Chlorthalidone and Hydrochlorothiazide: Results and Lessons Learned

    July 27, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Karen Margolis, MD, MPH HealthPartners Institute, Minneapolis, MN Stephen Fortmann, MD Kaiser Permanente Center for Health Research, Portland, OR Topic: Pilot Study for a Pragmatic Trial Comparing Chlorthalidone and […]

  • August 2018

  • Fri 3

    Grand Rounds August 3: A Digital Pragmatic Direct-to-Participant Clinical Trial for Identifying Undiagnosed Atrial Fibrillation in a Large Health Plan Population

    August 3, 2018 @ 1:00 pm - 2:00 pm

    Speaker: Steven R. Steinhubl, MD Director of Digital Medicine, Scripps Research Translational Institute Associate Professor, Molecular Medicine, Scripps Research Topic: A Digital Pragmatic Direct-to-Participant Clinical Trial for Identifying Undiagnosed Atrial […]

  • Fri 10

    Grand Rounds August 10: Using a Novel mHealth Platform to Obtain Real-World Data for Post-Market Surveillance: A NEST NIH Collaboratory Trial

    August 10, 2018 @ 1:00 pm - 2:00 pm

    Speaker: Sanket Dhruva, MD, MHS Assistant Professor of Clinical Medicine, UCSF School of Medicine Cardiologist, San Francisco VA Medical Center Topic: Using a Novel mHealth Platform to Obtain Real-World Data for […]

  • Fri 17

    Grand Rounds August 17: The PCORnet Bariatric Study: Preliminary Results from a Large PCORnet NIH Collaboratory Trial

    August 17, 2018 @ 1:00 pm - 2:00 pm

    Speakers: David Arterburn, MD, MPH Kaiser Permanente Washington Kathleen McTigue, MD, MPH University of Pittsburgh Medical Center Neely Williams, Mdiv Patient Collaborator, Mid-South CDRN Laura Rasmussen-Torvik, PhD Northwestern Medicine Topic: […]

  • Fri 24

    Grand Rounds August 24: FoodSwitch USA: A Mobile Platform for Packaged Food Surveillance and Behavioral Research

    August 24, 2018 @ 1:00 pm - 2:00 pm

    Speaker: Mark Huffman, MD, MPH Associate Professor of Preventive Medicine and Medicine-Cardiology Northwestern University Feinberg School of Medicine Topic: FoodSwitch USA: A Mobile Platform for Packaged Food Surveillance and Behavioral […]

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