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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 2024

  • Fri 14

    Grand Rounds June 14, 2024: DAPA-MI – A Pragmatic Registry-Based Double-Blind RCT Trial Designed For Regulatory Evaluation (Stefan James; Jonas Oldgren)

    June 14, 2024 @ 1:00 pm - 2:00 pm

    Speakers: Stefan James Professor Cardiology Dept. of Medical Sciences and Uppsala Clinical Research Center Uppsala University Uppsala, Sweden Jonas Oldgren Professor Cardiology Dept. of Medical Sciences and Uppsala Clinical Research Center Uppsala University Uppsala, Sweden Title: DAPA-MI - A Pragmatic Registry-Based Double-Blind RCT Trial Designed For Regulatory Evaluation Date: Friday, June 14, 2024, 1:00-2:00 p.m. […]

  • Thu 20

    Results from the Learning to Apply Mindfulness to Pain (LAMP) Study: A Pragmatic Clinical Trial

    June 20, 2024 @ 12:00 pm - 1:00 pm

    Diana Burgess, a co–principal investigator of the NIH Pragmatic Trials Collaboratory’s RAMP trial, will present the results of the precursor LAMP trial as part of the Veterans Affairs (VA) Health Systems […]

  • Fri 21

    Grand Rounds June 21, 2024: Efficacy and Safety of Electronic Cigarettes for Smoking Cessation: Keeping a Trial on a Polarizing Topic Running Under Regulatory and Epidemic Changes (Reto Auer, MD, MAS)

    June 21, 2024 @ 1:00 pm - 2:00 pm

    Speaker: Reto Auer, MD, MAS Associate Professor in Primary Health Care, Head Substance Use Unit, Institute of Primary Health Care (BIHAM), University of Bern Adjunct Physician, University Center for Primary Care and Public Health (Unisanté), Switzerland Title: Efficacy and Safety of Electronic Cigarettes for Smoking Cessation: Keeping a Trial on a Polarizing Topic Running Under […]

  • Fri 28

    Grand Rounds June 28, 2024: Using ChatGPT to Facilitate Truly Informed Medical Consent (Fatima N. Mirza, MD, MPH)

    June 28, 2024 @ 1:00 pm - 2:00 pm

    Speaker: Fatima N. Mirza, MD, MPH Chief Resident Department of Dermatology Warren Alpert Medical School of Brown University Title: Using ChatGPT to Facilitate Truly Informed Medical Consent Date: Friday, June 28, 2024, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link below: https://duke.zoom.us/j/95887412491?pwd=NEcvVFhrRklQQ1UxbjAzUUNua3o4dz09 Meeting ID: 958 8741 2491 Passcode: 574134 One […]

  • July 2024

  • Tue 9

    The Science of Partner Engagement in Research: Development and Validation of Evaluation Metrics

    July 9, 2024 @ 1:00 pm - 2:00 pm

    Melody S. Goodman, Ph.D. New York University School of Global Public Health Register for the webinar About the Webinar Partner engagement is a crucial part of participatory public health research, yet the measurement of partner engagement in research is varied, inconsistent, and not methodologically sound. Partner-engaged research approaches and a mixed-methods (qualitative/quantitative) study design are […]

  • Fri 12

    Grand Rounds July 12, 2024: Causal Estimands: Should We Ask Different Causal Questions in Randomized Trials and in the Observational Studies That Emulate Them? (Miguel Hernan, MD)

    July 12, 2024 @ 1:00 pm - 2:00 pm

    Speaker: Miguel Hernan, MD Professor of Biostatistics and Epidemiology CAUSALab Harvard T.H. Chan School of Public Health Title: Causal Estimands: Should We Ask Different Causal Questions in Randomized Trials and in the Observational Studies That Emulate Them? Date: Friday, July 12, 2024, 1:00-2:00 pm ET To join the online meeting: https://duke.zoom.us/j/99172752012?pwd=UzBTWE5laW8yOE42c2xTVVFuZmc3QT09 Meeting ID: 991 7275 […]

  • Mon 15

    Virtual Workshop: Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues

    Featured July 15, 2024 @ 1:00 pm - 4:00 pm

    The NIH Pragmatic Trials Collaboratory's virtual workshop will explore how to generate meaningful, actionable evidence through pragmatic research. Join the Videocast: https://videocast.nih.gov/watch=54927 Day 1: July 15, 1:00 pm–4:00 pm ET Phase Zero: Getting the Research Question Right Engagement as the Cornerstone in Pragmatic Research View the workshop flyer for detailed information and to register.

  • Tue 16

    Virtual Workshop: Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues

    Featured July 16, 2024 @ 11:00 am - 3:30 pm

    The NIH Pragmatic Trials Collaboratory's virtual workshop will explore how to generate meaningful, actionable evidence through pragmatic research. Day 2 will feature a keynote by NIH Director Dr. Monica Bertagnolli. Join the Videocast: https://videocast.nih.gov/watch=54928 Day 2: July 16, 11:00 am–3:30 pm ET Keynote: How Do We Identify the High-Priority Healthcare Issues That Require the Effort, […]

  • Fri 19

    Grand Rounds July 19, 2024: Lessons From PRECIDENTD: A Pragmatic Comparative Effectiveness Trial (Brendan M Everett, MD, MPH; Deborah J. Wexler, MD, MSc)

    July 19, 2024 @ 1:00 pm - 2:00 pm

    Speakers: Brendan M. Everett, MD, MPH Associate Professor of Medicine Divisions of Cardiology and Preventive Medicine Brigham and Women's Hospital and Harvard Medical School Deborah J. Wexler, MD, MSc Associate […]

  • Fri 26

    Grand Rounds July 26, 2024: Interventions for Optimization of Guideline-Directed Medical Therapy (Gregg C. Fonarow, MD)

    July 26, 2024 @ 1:00 pm - 2:00 pm

    Speaker: Gregg C. Fonarow, MD, FACC, FAHA, FHFSA Eliot Corday Professor of Cardiovascular Medicine and Science Director, Ahmanson-UCLA Cardiomyopathy Center Codirector, UCLA Preventative Cardiology Program UCLA Division of Cardiology Title: […]

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