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Living Textbook of
Pragmatic Clinical Trials

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Access the latest information on COVID-19 for clinical researchers
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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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  • March 2018

  • Wed 7

    March 7, 2018: PCORnet Best Practice Sharing Session: Lessons Learned in ADAPTABLE

    Featured March 7, 2018 @ 2:00 pm - 3:00 pm

    PCORnet Best Practice Sharing Session – Lessons Learned in ADAPTABLE: Recruitment, Retention, and Endpoint Ascertainment Join WebEx meeting: https://dukemed.webex.com/dukemed/j.php?MTID=m350d72f769538a3c056d0835692bae2a Phone: 1-650-479-3207 / Meeting Number (access code): 730 973 890 Speakers: […]

  • Fri 9

    gm

    Featured March 9, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Eric B. Larson, MD, MPH Vice President, Research and Health Care Innovation Kaiser Foundation Health Plan of Washington Executive Director and Senior Investigator Kaiser Permanente Washington Health Research Institute Paula Lozano, MD, MPH Associate Medical Director for Research and Translation Senior Investigator Kaiser Permanente Washington Health Research Institute Joan DeClaire Director, Communications Kaiser Permanente […]

  • Fri 16

    Grand Rounds March 16: Straight from the Source: Clinicians’ Views on Participating in CER/PCOR (Ellen Tambor, MA; Rachael Moloney, MHS; Sean Tunis, MD, MSc)

    Featured March 16, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Ellen Tambor, MA Research Director Center for Medical Technology Policy (CMTP) Rachael Moloney, MHS Research Manager Center for Medical Technology Policy (CMTP) Sean Tunis, MD, MSc President and CEO Center for Medical Technology Policy (CMTP) Topic: Straight from the Source: Clinicians’ Views on Participating in CER/PCOR Date: Friday, March 16, 2018, 1:00-2:00 p.m. ET […]

  • Mon 19

    March 19: OHDSI: FDA Workshop: Developing & Submitting Proposed Draft Guidance on Patient Experience Data

    Featured March 19, 2018 @ 1:00 pm - 5:00 pm

    Topic: FDA Workshop: Developing & Submitting Proposed Draft Guidance on Patient Experience Data The purpose of this public workshop is to obtain input from stakeholders on considerations for development and […]

  • 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 […]

  • 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. […]

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