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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.

Events

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  • February 2018

  • Fri 2

    Grand Rounds February 2: Early Progress on the All of Us Research Program (Joshua C. Denny, MD, MS, FACMI)

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

    Speaker: Joshua C. Denny, MD, MS, FACMI Professor of Biomedical Informatics and Medicine Director, Center for Precision Medicine Vice President for Personalized Medicine Vanderbilt University Medical Center Topic: Early Progress […]

  • Fri 9

    Grand Rounds February 9: Linking Design to Analysis of Cluster Randomized Trials: Covariate Balancing Strategies (Fan Li, PhD)

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

    Speaker: Fan Li, PhD Candidate in Biostatistics Department of Biostatistics and Bioinformatics Duke University Topic: Linking Design to Analysis of Cluster Randomized Trials: Covariate Balancing Strategies Date: Friday, February 9, 2018, […]

  • Fri 16

    Grand Rounds February 16: Considerations for the Return of Genomic Results (Heidi Rehm, PhD, FACMG; W. Andrew Faucett, MS, LGC)

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

    Speakers: Heidi Rehm, PhD, FACMG Associate Professor of Pathology Brigham & Women's Hospital and Harvard Medical School W. Andrew (Andy) Faucett, MS, LGC Professor Director of Policy and Education Office of the Chief Scientific Officer Geisinger Topic: Considerations for the Return of Genomic Results Date: Friday, February 16, 2018, 1:00-2:00 p.m. ET Meeting Info: To […]

  • Fri 23

    Grand Rounds February 23: Direct Mail Programs Work… But Will Health Centers Implement Them? Findings from STOP CRC (Gloria D. Coronado, PhD; Beverly B. Green, MD, MPH)

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

    Speakers: Gloria D. Coronado, PhD Senior Investigator Mitch Greenlick Endowed Scientist for Health Disparities Kaiser Permanente Center for Health Research Beverly B. Green, MD, MPH Associate Investigator Kaiser Permanente Washington Health Research Institute Topic: Direct Mail Programs Work… But Will Health Centers Implement Them? Findings from STOP CRC Date: Friday, February 23, 2018, 1:00-2:00 p.m. […]

  • March 2018

  • Fri 2

    Grand Rounds March 2: Distributed Research Network Querying: A Status Report (Jeff Brown, PhD; Lesley H. Curtis, PhD; Richard Platt, MD, MSc)

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

    Speakers: Jeff Brown, PhD Associate Professor, Department of Population Medicine Harvard Pilgrim Health Care Institute Lesley H. Curtis, PhD Professor of Medicine Director, Center for Population Health Sciences, Duke School of Medicine Director, Center for Pragmatic Health Systems Research, Duke Clinical Research Institute Richard Platt, MD, MS Professor and Chair, Department of Population Medicine Harvard […]

  • Tue 6

    March 6-7: Real-World Evidence Workshop Series- Workshop 2: Practical Approaches

    Featured March 6, 2018 @ 8:00 am - March 7, 2018 @ 12:30 pm

    The National Academies of Sciences, Engineering, and Medicine (National Academies) is convening the second workshop in a three-part series examining how real-world evidence development and uptake can enhance medical product development and evaluation. The workshops will advance discussions and common knowledge about complex issues relating to the generation and utilization of real-world evidence, including fostering […]

  • 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: Schuyler Jones, MD, and Holly Robertson, PhD More information on PCORnet Website: http://pcornet.org/event/pcornet-best-practice-sharing-session-lessons-learned-adaptable-recruitment-retention-endpoint-ascertainment/ All are welcome to attend! For those unable to join, the meeting […]

  • 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 submission of proposed draft guidance relating to patient experience data submitted by an external stakeholder, including: Defining the scope of the proposed draft guidance Developing […]

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