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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
33 events found.

Events

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  • November 2023

  • Fri 10

    Grand Rounds November 10, 2023: No Presentation (Holiday)

    November 10, 2023 @ 1:00 pm - 2:00 pm
  • Fri 17

    Grand Rounds November 17, 2023: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: Results from the Nudge Study (Michael Ho, MD, PhD; Sheana Bull, PhD)

    November 17, 2023 @ 1:00 pm - 2:00 pm

    Speakers: Michael Ho, MD, PhD University of Colorado Sheana Bull, PhD University of Colorado Topic: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: Results from […]

  • Fri 24

    Grand Rounds November 24, 2023: No Presentation (Holiday)

    November 24, 2023 @ 1:00 pm - 2:00 pm
  • Tue 28

    Exploratory and Inferential Spatial Statistical Methods: Tools To Understand the Geography of Health Across the U.S.

    November 28, 2023 @ 1:00 pm - 3:00 pm

    Presenter Lori Philip Tabb, PhD Associate Professor of Biostatistics Drexel University’s Dornsife School of Public Health About the Webinar Exploratory and inferential spatial statistical methods are the tools needed to […]

  • December 2023

  • Fri 1

    Grand Rounds Biostatistics Series December 1, 2023: Guidelines for Design and Analysis of Stepped-Wedge Trials (Jim Hughes, PhD; Moderator: Patrick Heagerty, PhD)

    December 1, 2023 @ 1:00 pm - 2:00 pm

    Speaker: James P. Hughes, PhD Professor Emeritus of Biostatistics, University of Washington Moderator: Patrick J. Heagerty, PhD Professor of Biostatistics, University of Washington Topic: Guidelines for Design and Analysis of Stepped-Wedge Trials Date: Friday, December 1, 2023, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link below: https://duke.zoom.us/j/97816533886?pwd=MnRQUUVpTnpnZnF6MTFIdmRkazJpZz09 Meeting ID: 978 […]

  • Wed 6

    NIH Clinical Center Grand Rounds: “The Ethics Of ‘Other Motivations’ for Seeking Care and Enrolling in Research”

    December 6, 2023 @ 12:00 pm - 1:00 pm

    NIH Clinical Center Grand Rounds "The Ethics of 'Other Motivations' for Seeking Care and Enrolling in Research" William Gahl, MD, PhD Senior Investigator, National Human Genome Research Institute (NHGRI) https://videocast.nih.gov/watch=53801

  • Fri 8

    Grand Rounds December 8, 2023: A Pragmatic Randomized Trial of the Jumpstart Intervention to Promote Communication About Goals of Care for Hospitalized Patients with Serious Illness (Ruth Engelberg, PhD; Erin Kross, MD; Robert Lee, MD, MS)

    December 8, 2023 @ 1:00 pm - 2:00 pm

    Speakers: Ruth Engelberg PhD Research Professor of Medicine Division of Pulmonary, Critical Care and Sleep Medicine University of Washington Erin Kross MD, Associate Professor of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine University of Washington Robert Lee MD MS Assistant Professor of Medicine Division of Pulmonary, Critical Care and Sleep Medicine University of Washington […]

  • Fri 15

    Grand Rounds December 15, 2023: Diversifying Clinical Trials:  A Path Forward (Roxana Mehran, MD)

    December 15, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Roxana Mehran, MD Icahn School of Medicine at Mount Sinai Title: Diversifying Clinical Trials:  A Path Forward Date: Friday, December 15, 2023, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link below: https://duke.zoom.us/j/95368337688?pwd=dUdVU0ZxblR2MEIrUS9Scm9rbEZiZz09 Meeting ID: 953 6833 7688 Passcode: 499751 One tap mobile +13017158592,,95368337688#,,,,*499751# US (Washington DC) +13052241968,,95368337688#,,,,*499751# US Find […]

  • Fri 22

    Grand Rounds December 22, 2023: No Presentation (Holiday)

    December 22, 2023 @ 1:00 pm - 2:00 pm
  • Fri 29

    Grand Rounds December 29, 2023: No Presentation (Holiday)

    December 29, 2023 @ 1:00 pm - 2:00 pm
  • January 2024

  • Fri 5

    Grand Rounds Biostatistics Series January 5, 2024: Methods for Handling Missing Data in Cluster Randomized Trials (Rui Wang, PhD; Moderator: Fan Li, PhD)

    January 5, 2024 @ 1:00 pm - 2:00 pm

    Speaker: Rui Wang, PhD Associate Professor of Population Medicine and Associate Professor in the Department of Biostatistics, Harvard Pilgrim Health Care Institute and Harvard Medical School Moderator: Fan Li, PhD Assistant Professor of Biostatistics, Yale School of Public Health Topic: Methods for Handling Missing Data in Cluster Randomized Trials Date: Friday, January 5, 2024, 1:00-2:00 […]

  • Fri 12

    Grand Rounds January 12, 2024: Design And Implementation Of A Weighted Lottery To Equitably Allocate Scarce COVID-19 Resources (Erin K. McCreary, PharmD, BCIDP)

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

    Speaker: Erin K. McCreary, PharmD, BCIDP Director of Infectious Diseases Improvement and Clinical Research Innovation, UPMC Clinical Assistant Professor of Medicine, University of Pittsburgh President-Elect, Society of Infectious Diseases Pharmacists (SIDP) Title: Design and Implementation of a Weighted Lottery to Equitably Allocate Scarce Covid-19 Resources Date: Friday, January 12, 2024, 1:00-2:00 p.m. ET To join […]

  • Fri 19

    Grand Rounds January 19, 2024: Why Are Imaging RCTs Different? Lessons From Chest Pain Evaluation Trials (Pamela S. Douglas, MD, MACC, FASE, FAHA)

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

    Speaker: Pamela S. Douglas, MD, MACC, FASE, FAHA Ursula Geller Professor of Research in Cardiovascular Diseases Duke Clinical Research Institute - Duke University Past President, American College of Cardiology Past President, American Society of Echocardiography Title: Why Are Imaging RCTs Different? Lessons From Chest Pain Evaluation Trials Date: Friday, January 19, 2024, 1:00-2:00 p.m. ET […]

  • Fri 26

    Grand Rounds January 26, 2024: Advancing the Safe, Effective, and Equitable Use of AI in Healthcare (Suresh Balu, MD, MBA; Mark Sendak, MD, MPP)

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

    Speakers: Suresh Balu, MD, MBA Director, Duke Institute for Health Innovation (DIHI) Associate Dean, Innovation and Partnership Duke School of Medicine Mark Sendak, MD, MPP Population Health & Data Science lead Duke Institute for Health Innovation (DIHI) Title: Advancing the Safe, Effective, and Equitable Use of AI in Healthcare Date: Friday, January 26, 2024, 1:00-2:00 […]

  • February 2024

  • Fri 2

    Grand Rounds February 2, 2024: Strategies for Improving Public Understanding of the FDA and the Products It Regulates: Why Should We Care, and What Might We Do? (Susan C. Winckler, RPh, Esq)

    February 2, 2024 @ 1:00 pm - 2:00 pm

    Speaker: Susan C. Winckler, RPh, Esq Chief Executive Officer Reagan-Udall Foundation for the FDA Title: Strategies for Improving Public Understanding of the FDA and the Products It Regulates: Why Should We Care, and What Might We Do? Date: Friday, February 2, 2024, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link […]

  • Wed 7

    NIH Clinical Center Grand Rounds: “Supported Decision-Making in Research”

    February 7, 2024 @ 12:00 pm - 1:00 pm

    NIH Clinical Center Grand Rounds: "Supported Decision-Making in Research" Discussant: Nina A. Kohn, JD David M. Levy Professor of Law Syracuse University College of Law; Distinguished Scholar in Elder Law Solomon Center for Health Law & Politics Yale Law School https://videocast.nih.gov/

  • Fri 9

    Grand Rounds February 9, 2024: Pragmatic Recruitment of Underrepresented Groups – Experience From the Diuretic Comparison Project (Cynthia Hau, MPH)

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

    Speaker: Cynthia Hau, MPH Statistician Boston Cooperative Studies Program Coordinating Center VA Boston Healthcare System Title: Pragmatic Recruitment of Underrepresented Groups – Experience From the Diuretic Comparison Project Date: Friday, February 9, 2024, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link below: https://duke.zoom.us/j/91642350759?pwd=eGdJNWdKOHJZUEZUZHE3T3BzRDB0UT09 Meeting ID: 916 4235 0759 Passcode: 318361 […]

  • Fri 16

    Grand Rounds February 16, 2024: Clinical Implications of the MINT Trial: p=0.07 (Jeffrey Carson, MD, MACP)

    February 16, 2024 @ 1:00 pm - 2:00 pm

    Speaker: Jeffrey Carson, MD, MACP Principal Investigator and Study Chair MINT Trial Provost-New Brunswick, Rutgers Biomedical Health Sciences Distinguished Professor of Medicine Richard C. Reynolds, M.D. Chair in General Internal Medicine Rutgers, Robert Wood Johnson Medical School Title: Clinical Implications of the MINT Trial: p=0.07 Date: Friday, February 16, 2024, 1:00-2:00 p.m. ET To join the online meeting: Click […]

  • Fri 23

    Grand Rounds February 23, 2024: Virtual Vigilance: Monitoring of Decentralized Clinical Trials (Adrian Hernandez, MD; Christopher J. Lindsell, PhD)

    February 23, 2024 @ 1:00 pm - 2:00 pm

    Speakers: Adrian Hernandez, MD Executive Director, Duke Clinical Research Institute Vice Dean, Duke University School of Medicine Christopher J. Lindsell, PhD Professor and co-Chief of Biostatistics, Department of Biostatistics & Bioinformatics Director, Data Science and Biostatistics, Duke Clinical Research Institute Duke University School of Medicine Editor in Chief, Journal of Clinical and translational Science Title: […]

  • March 2024

  • Fri 1

    Grand Rounds March 1, 2024: Effect of an Intensive Food-as-Medicine Program on Health and Healthcare Use: Evidence From a Randomized Clinical Trial (Joseph Doyle, PhD)

    March 1, 2024 @ 1:00 pm - 2:00 pm

    Speaker: Joseph Doyle, PhD Erwin H. Schell Professor of Management and Applied Economics MIT Sloan School of Management Title: Effect of an Intensive Food-as-Medicine Program on Health and Healthcare Use: Evidence From a Randomized Clinical Trial Date: Friday, March 1, 2024, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link below: […]

  • Fri 8

    Grand Rounds March 8, 2024: Public-Private Partnerships in the Trustworthy Health AI Ecosystem (Michael Pencina, PhD; Brian Anderson, MD)

    March 8, 2024 @ 1:00 pm - 2:00 pm

    Speakers: Michael Pencina, PhD Chief Data Scientist, Duke Health Professor of Biostatistics and Bioinformatics and Vice Dean for Data Science, Duke University School of Medicine Brian Anderson, MD CEO, Coalition for Health AI Title: Public-private Partnerships in the Trustworthy Health AI Ecosystem Date: Friday, March 8, 2024, 1:00-2:00 p.m. ET To join the online meeting: […]

  • Fri 15

    Grand Rounds March 15, 2024: The Effect of Antibiotic Choice on Renal Outcomes: The ACORN Trial (Edward Qian, MD, MSc)

    March 15, 2024 @ 1:00 pm - 2:00 pm

    Speaker: Edward Qian, MD, MSc Assistant Professor of Medicine Vanderbilt University Medical Center Division of Pulmonary and Critical Care Medicine Title: The Effect of Antibiotic Choice on Renal Outcomes: The ACORN Trial Date: Friday, March 15, 2024, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link below: https://duke.zoom.us/j/97453499746?pwd=bXRuaGQ3V2R3ZWJQdUJlSTZGNGo2dz09 Meeting ID: 974 […]

  • Wed 20

    Mind the Gap Webinar Series: Deconstruction of the Type 2 Hybrid Effectiveness-Implementation Study Design that Uses Two Randomized Controlled Trials

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

    Deconstruction of the Type 2 Hybrid Effectiveness-Implementation Study Design that Uses Two Randomized Controlled Trials Register now Presented byJune Stevens, Ph.D. March 20, 202412:00 noon–1:00 p.m. ET About the Webinar Implementation research addresses barriers to the successful conduct of interventions aimed at improving health. Thus, implementation scientists are often interested in examining both the success of […]

  • Fri 22

    Grand Rounds March 22, 2024: Early Diagnosis and Assessment of Autism Via Objective Measurements of Social Visual Engagement (Warren Jones, PhD)

    March 22, 2024 @ 1:00 pm - 2:00 pm

    Speaker: Warren Jones, PhD Director of Research, Marcus Autism Center Children's Healthcare of Atlanta Norman Nien Distinguished Chair in Autism Associate Professor, Dept. of Pediatrics Emory University School of Medicine Title: Early Diagnosis and Assessment of Autism Via Objective Measurements of Social Visual Engagement Date: Friday, March 22, 2024, 1:00-2:00 p.m. ET To join the […]

  • Wed 27

    Prevention in Focus Webinar Series: Is It More than PMS? Learn About PMDD

    March 27, 2024 @ 1:00 pm - 2:00 pm

    Prevention in Focus Webinar Series: It More than PMS? Learn About PMDD Marybeth Bohn, International Association for Premenstrual Disorders Sandi MacDonald, International Association for Premenstrual Disorders Register for the webinar *A recording of this webinar will be available approximately two weeks after the session. About the Webinar Marybeth Bohn witnessed her 33-year-old daughter Christina’s suffering […]

  • Fri 29

    Grand Rounds March 29, 2024: Effect Of A Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation: A Pragmatic, Cluster-Randomized Trial (Amit Garg, MD, MA, FRCPC, FACP, PhD; Stephanie N. Dixon, PhD, MSc)

    March 29, 2024 @ 1:00 pm - 2:00 pm

    Speakers: Amit Garg, MD, MA (Education) FRCPC, FACP, PhD Associate Dean, Clinical Research, Schulich School of Medicine and Dentistry Lead, Institute for Clinical Evaluative Sciences Kidney, Dialysis and Transplantation Provincial Program Director, Institute for Clinical Evaluative Sciences (ICES) Western Facility Nephrologist, London Health Sciences Centre Professor, Medicine, Epidemiology & Biostatistics, Western University  Stephanie N. Dixon, […]

  • April 2024

  • Wed 3

    NIH Clinical Center Grand Rounds: “How Can We Respect the Dead?”

    April 3, 2024 @ 12:00 pm - 1:00 pm

    NIH Clinical Center Grand Rounds: “How Can We Respect the Dead?” Discussant: Neal Dickert MD, PhD Thomas R. Williams Professor of Medicine, Emory University https://videocast.nih.gov/

  • Fri 5

    Grand Rounds April 5, 2024: A New Look at P Values for Randomized Clinical Trials (Erik van Zwet, PhD)

    April 5, 2024 @ 1:00 pm - 2:00 pm

    Speaker: Erik van Zwet, PhD Department of Biomedical Data Sciences Leiden University Medical Center, the Netherlands Title: A New Look at P Values for Randomized Clinical Trials Date: Friday, April 5, 2024, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link below: https://duke.zoom.us/j/98292370425?pwd=S05sOU42WXp3NXNjK0ZkczN0WXpHUT09 Meeting ID: 982 9237 0425 Passcode: 237056 One […]

  • Fri 5

    2024 Allan Donner Lecture: The Unit of Inference in Cluster Randomized Trials

    April 5, 2024 @ 1:30 pm - 2:30 pm

    2024 Allan Donner Lecture: Dr. Fan Li Date: Friday, April 5 Time: 1:30 pm - 2:30 pm Location: PHFM 3015 (Western Centre for Public Health and Family Medicine) or Zoom (link may be requested at EpiBio@uwo.ca) Link: https://www.schulich.uwo.ca/epibio/about_us/events/2024/2024_Allan_Donner_Lecture.html The unit of inference in cluster randomized trials Fan Li Assistant Professor  Department of Biostatistics Yale School of Public Health, Yale […]

  • Fri 12

    Grand Rounds April 12, 2024: Primary Palliative Care for Emergency Medicine, a Cluster Randomized Stepped-Wedge Trial Across 33 Emergency Departments (Corita R. Grudzen, MD, MSHS, FACEP)

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

    Speaker: Corita R. Grudzen, MD, MSHS, FACEP Fern Grayer Chair in Oncology Care and the Patient Experience Division Head, Supportive and Acute Care Services Memorial Sloan Kettering Cancer Center Professor […]

  • Fri 19

    Grand Rounds April 19, 2024: The Yale Open Data Access (YODA) Project: 10 Years of Clinical Trial Data Sharing (Joseph S. Ross, MD, MHS)

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

    Speaker: Joseph S. Ross, MD, MHS Professor of Medicine and Public Health Yale University Title: The Yale Open Data Access (YODA) Project: 10 Years of Clinical Trial Data Sharing Date: […]

  • Fri 26

    Grand Rounds April 26, 2024: Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations – FDA Regulation Development and Research Landscape (Lauren Milner, PhD; Jonathan Casey, MD, MSCI; Matthew Semler, MD, MSCI)

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

    Speakers: Lauren Milner, PhD Office of Clinical Policy US Food and Drug Administration  (FDA) Jonathan Casey, M.D., MSCI Assistant Professor, Division of Pulmonary and Critical Care Medicine Vanderbilt University Medical […]

  • May 2024

  • Fri 3

    Grand Rounds May 3, 2024: Comparative Effectiveness of Kidney Stone Surgery in Pediatric Patients: The PKIDS Trial (Gregory Tasian, MD, MSc, MSCE)

    May 3, 2024 @ 1:00 pm - 2:00 pm

    Speaker: Gregory Tasian, MD, MSc, MSCE Associate Professor of Surgery and Epidemiology Children’s Hospital of Philadelphia Title: Comparative Effectiveness of Kidney Stone Surgery in Pediatric Patients: The PKIDS Trial Date: […]

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