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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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  • June 2017

  • Fri 30

    June 30 Grand Rounds: The Yale Open Data Access (YODA) Project: Lessons Learned in Data Sharing (Joseph S. Ross, MD, MHS)

    Featured June 30, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    ​Speaker: Joseph S. Ross, MD, MHS Associate Professor of Medicine, General Medicine, and Public Health, Health Policy and Management Yale University School of Medicine Topic: The Yale Open Data Access (YODA) Project: Lessons Learned in Data Sharing Date: Friday, June 30, 2017, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF […]

  • July 2017

  • Fri 7

    Grand Rounds: July 7: Ethics and the Precision Medicine Initiative: Reflections from Working on the CentralPMI IRB (Nancy Kass, ScD)

    July 7, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    ​Speaker: Nancy Kass, ScD Phoebe R. Berman Professor of Bioethics and Public Health Johns Hopkins Berman Institute of Bioethics Johns Hopkins Bloomberg School of Public Health Topic: Ethics and the Precision Medicine Initiative: Reflections from Working on the CentralPMI IRB Date: Friday, July 7, 2017, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed […]

  • Fri 7

    July 7 Grand Rounds: Ethics and the Precision Medicine Initiative: Reflections from Working on the CentralPMI IRB (Nancy Kass, ScD)

    Featured July 7, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    ​Speaker: Nancy Kass, ScD Phoebe R. Berman Professor of Bioethics and Public Health Johns Hopkins Berman Institute of Bioethics Johns Hopkins Bloomberg School of Public Health Topic: Ethics and the Precision Medicine Initiative: Reflections from Working on the CentralPMI IRB Date: Friday, July 7, 2017, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed […]

  • Fri 28

    Grand Rounds: July 28: The DSMB Role in Pragmatic Trials: NIMH Progress and Challenges (Galia Siegel, PhD; Anna Ordonez, MD, MAS; Scott Kim, MD, PhD; Kate Comtois, PhD, MPH)

    July 28, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    ​Speakers: Galia Siegel, PhD Clinical Trials Program Coordinator Clinical Trials Operations and Biostatistics Branch Office of Clinical Research National Institute of Mental Health, NIH Anna E. Ordóñez, MD, MAS Deputy Director Office of Clinical Research National Institute of Mental Health, NIH Scott Kim, MD, PhD Senior Investigator, Department of Bioethics Clinical Center National Institutes of […]

  • Fri 28

    Grand Rounds: July 28: The DSMB Role in Pragmatic Trials: NIMH Progress and Challenges (Galia Siegel, PhD; Anna Ordonez, MD, MAS; Scott Kim, MD, PhD; Kate Comtois, PhD, MPH)

    Featured July 28, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    ​Speakers: Galia Siegel, PhD Clinical Trials Program Coordinator Clinical Trials Operations and Biostatistics Branch Office of Clinical Research National Institute of Mental Health, NIH Anna E. Ordóñez, MD, MAS Deputy Director Office of Clinical Research National Institute of Mental Health, NIH Scott Kim, MD, PhD Senior Investigator, Department of Bioethics Clinical Center National Institutes of […]

  • August 2017

  • Fri 11

    Grand Rounds: August 11: Embedding Clinical Trials Into Care Delivery: The Vanderbilt Experience (Gordon Bernard, MD)

    August 11, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    ​Speaker: Gordon R. Bernard, MD Melinda Owen Bass Professor of Medicine Executive Vice President for Research Director, Vanderbilt Institute for Clinical and Translational Research Vanderbilt University Medical Center Topic: Embedding Clinical Trials Into Care Delivery: The Vanderbilt Experience Date: Friday, August 11, 2017, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for […]

  • Fri 11

    Grand Rounds: August 11: Embedding Clinical Trials Into Care Delivery: The Vanderbilt Experience (Gordon Bernard, MD)

    Featured August 11, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    ​Speaker: Gordon R. Bernard, MD Melinda Owen Bass Professor of Medicine Executive Vice President for Research Director, Vanderbilt Institute for Clinical and Translational Research Vanderbilt University Medical Center Topic: Embedding Clinical Trials Into Care Delivery: The Vanderbilt Experience Date: Friday, August 11, 2017, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for […]

  • Fri 18

    Grand Rounds: August 18: Behavioral Economic Incentives in Adolescents and Young Adults: A Developmental Framework and RCT of Financial Incentives in Youth with Type 1 Diabetes (Charlene Wong, MD)

    August 18, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    ​Speaker: Charlene Wong, MD Assistant Professor Department of Pediatrics Duke Clinical Research Institute Margolis Center for Health Policy Duke University Topic: Behavioral Economic Incentives in Adolescents and Young Adults: A Developmental Framework and RCT of Financial Incentives in Youth with Type 1 Diabetes Date: Friday, August 18, 2017, 1:00-2:00 p.m. ET Meeting Info: To check whether you have […]

  • Fri 18

    Grand Rounds: August 18: Behavioral Economic Incentives in Adolescents and Young Adults: A Developmental Framework and RCT of Financial Incentives in Youth with Type 1 Diabetes (Charlene Wong, MD)

    Featured August 18, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    ​Speaker: Charlene Wong, MD Assistant Professor Department of Pediatrics Duke Clinical Research Institute Margolis Center for Health Policy Duke University Topic: Behavioral Economic Incentives in Adolescents and Young Adults: A Developmental Framework and RCT of Financial Incentives in Youth with Type 1 Diabetes Date: Friday, August 18, 2017, 1:00-2:00 p.m. ET Meeting Info: To check whether you have […]

  • Fri 25

    Grand Rounds August 25: Update and Thoughts from the Phenotypes, Data Standards, and Data Quality Core of the NIH HCS Research Collaboratory (Rachel Richesson, PhD, MPH)

    Featured August 25, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Rachel Richesson, PhD, MPH Associate Professor Duke University School of Nursing Topic: Update and Thoughts from the Phenotypes, Data Standards, and Data Quality Core of the NIH HCS Research Collaboratory Date: Friday, August 25, 2017, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) […]

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