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Living Textbook of
Pragmatic Clinical Trials

COVID-19 Resources

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
    • 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
39 events found.

Events

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  • October 2020

  • Fri 9

    Grand Rounds October 9: Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo)

    October 9, 2020 @ 1:00 pm - 2:00 pm

    Speaker: Myles Wolf, MD, MMSc Division of Nephrology, Department of Medicine Duke Clinical Research Institute Duke University School of Medicine Topic: Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo) Date: Friday, October 9, 2020, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for […]

  • Thu 15

    October 15, 2020: NIA IMPACT Collaboratory Grand Rounds: The AHRQ and Lancet Reports on Dementia Interventions: Interpretation and Implications for Embedded Pragmatic Trials

    October 15, 2020 @ 12:00 pm - 1:00 pm

    Presenters: Joe Gaugler, PhD Robert L. Kane Endowed Chair in Long-Term Care and Aging Professor, University of Minnesota Associate Core Leader, IMPACT Implementation Core Eric Larson, MD, MPH Vice President, […]

  • Fri 16

    Grand Rounds October 16: Back to School, It’s More Than Just a Trip to Target This Year: The ABC Science Collaborative

    October 16, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Danny Benjamin, MD, PhD Kiser-Arena Distinguished Professor of Pediatrics, Duke University Chair, Pediatric Trials Network Deputy Director, Duke Clinical Research Institute Topic: Back to School, It’s More Than Just […]

  • Fri 23

    Grand Rounds October 23: Outpatient Clinical Decision Support – An Evidence-Based Implementation Framework

    October 23, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Patrick O'Connor, MD, MA, MPH Senior Clinical Investigator HealthPartners Institute JoAnn Sperl-Hillen, MD Senior Clinical Investigator HealthPartners Institute Topic: Outpatient Clinical Decision Support - An Evidence Based Implementation Framework […]

  • Tue 27

    October 27-30: Simplifying Informed Consent – OHRP Virtual Workshop at the NIH Office of Extramural Research Fall Regional Seminar

    October 27, 2020 @ 8:00 am - October 30, 2020 @ 5:00 pm

    The NIH Office of Extramural Research (OER) will host its semi-annual regional seminar virtually this fall from October 27-30. Registration is required, and the event is free. Mark your calendars […]

  • Fri 30

    Grand Rounds October 30: Lessons from Virtual Trials in Time of a Pandemic: Minnesota Hydroxychloroquine Experience

    October 30, 2020 @ 1:00 pm - 2:00 pm

    Speaker: David R. Boulware MD, MPH Professor of Medicine Infectious Disease & International Medicine Department of Medicine University of Minnesota Topic: Lessons from Virtual Trials in Time of a Pandemic: […]

  • November 2020

  • Fri 6

    Grand Rounds November 6: Appendectomy vs Antibiotics for Appendicitis-Early Results from the CODA trial

    November 6, 2020 @ 1:00 pm - 2:00 pm

    Speaker: David R. Flum, MD, MPH Professor, Surgery, Health Services, and Pharmacy Associate Chair for Research, Department of Surgery University of Washington Topic: Appendectomy vs Antibiotics for Appendicitis-Early Results from the […]

  • Fri 13

    Grand Rounds November 13: Pragmatic and Explanatory Attitudes to RCTs: Using the PRECIS-2 Tool to Describe the Design of the MyTEMP Trial

    November 13, 2020 @ 1:00 pm - 2:00 pm

    Speaker: Ahmed Al-Jaishi, PhD (candidate) Health Research Methodology McMaster University Amit Garg, MD, PhD Professor, Department of Medicine Epidemiology & Biostatistics Western University, London, Canada Senior Core Scientist, Site Director, and Program Lead ICES Western Kidney Dialysis & Transplantation Research Program, London, Canada Nephrologist, London Health Sciences Centre Victoria Hospital, London, Canada Merrick Zwarenstein,  MBBCh, […]

  • Thu 19

    NIA IMPACT Collaboratory Grand Rounds: Implementation Outcomes: Their Role in Treatment Success

    November 19, 2020 @ 12:00 pm - 1:00 pm

    Presenter: Enola Proctor, PhD Shanti K. Khinduka Distinguished Professor Emeritus Brown School Washington University, St. Louis Zoom Details: Please click the link below to join the webinar: https://hebrewseniorlife.zoom.us/j/97344810673 Webinar ID: […]

  • Fri 20

    Grand Rounds November 20: Drug Development in Kidney Disease: Proceedings from a Multi-Stakeholder Panel

    November 20, 2020 @ 1:00 pm - 2:00 pm

    Speaker: Daniel Edmonston, MD Medical Instructor Duke University School of Medicine Topic: Drug Development in Kidney Disease: Proceedings from a Multi-Stakeholder Panel Date: Friday, November 20, 2020, 1:00-2:00 p.m. ET […]

  • December 2020

  • Fri 4

    Grand Rounds December 4: The Yale New Haven Health System as an Evidence Generation Ecosystem for Heart Failure

    December 4, 2020 @ 1:00 pm - 2:00 pm

    Speaker: Tariq Ahmad, MD, MPH Director, Advanced Heart Failure Program Yale School of Medicine and Yale New Haven Health Topic: The Yale New Haven Health System as an Evidence Generation […]

  • Fri 11

    Grand Rounds December 11: PREVENTABLE: Starting a Pragmatic Trial in a Pandemic

    December 11, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Karen P. Alexander, MD Professor of Medicine/Cardiology Duke University School of Medicine W. Schuyler Jones, MD Associate Professor of Medicine/Cardiology Duke University School of Medicine Topic: PREVENTABLE: Starting a […]

  • Thu 17

    NIA IMPACT Collaboratory Grand Rounds: Improving Serious Illness Care Through Large Pragmatic Trials

    December 17, 2020 @ 12:00 pm - 1:00 pm

    Presenter: Scott Halpern, MD, PhD John M. Eisenberg Professor of Medicine, Epidemiology, and Medical Ethics and Health Policy University of Pennsylvania Zoom Details: Please click the link below to join […]

  • Fri 18

    Grand Rounds December 18: The SAMSON Trial: An N-of-1 Trial of Statin, Placebo, and No Treatment to Assess Patient Symptoms

    December 18, 2020 @ 1:00 pm - 2:00 pm

    Speaker: Matthew Shun-Shin BMBCh, PhD Imperial College London Topic: The SAMSON Trial: An N-of-1 Trial of Statin, Placebo, and No Treatment to Assess Patient Symptoms Date: Friday, December 18, 2020, […]

  • Fri 25

    Grand Rounds December 25: No Presentation (Holiday Break)

    December 25, 2020 @ 1:00 pm - 2:00 pm
  • January 2021

  • Fri 1

    Grand Rounds January 1: No Presentation (New Year’s Day)

    January 1, 2021 @ 1:00 pm - 2:00 pm
  • Fri 8

    Grand Rounds January 8: HERO-Together: Building Vaccine Confidence With Long-Term Outcomes Data

    January 8, 2021 @ 1:00 pm - 2:00 pm

    Speaker: Emily O’Brien, PhD, FAHA Associate Professor Duke Clinical Research Institute Duke University School of Medicine Department of Population Health Sciences Topic: HERO-Together: Building Vaccine Confidence With Long-Term Outcomes Data […]

  • Wed 13

    National Advisory Council on Aging: “COVID in US Nursing Homes: The Power of Data”

    January 13, 2021 @ 12:15 pm - 12:45 pm

    Live videocast of Vince Mor, PhD presenting at the National Advisory Council on Aging: "COVID in US Nursing Homes: The Power of Data" Join the live videocast on Wednesday, January […]

  • Fri 15

    Grand Rounds January 15: How CTTI & the Clinical Trials Community Have Risen to Meet the Challenge of the COVID-19 Pandemic

    January 15, 2021 @ 1:00 pm - 2:00 pm

    Speaker: Pamela Tenaerts, MD, MBA Executive Director Clinical Trials Transformation Initiative Topic: How CTTI & the Clinical Trials Community Have Risen to Meet the Challenge of the COVID-19 Pandemic Date: […]

  • Thu 21

    NIA IMPACT Collaboratory Grand Rounds January 21: Implementation in Ongoing AD/ADRD ePCTS in Different Health Care Settings Using Real Examples

    January 21, 2021 @ 12:00 pm - 1:00 pm

    Presenters: Ab Brody, PhD, RN, FAAN New York University Rory Meyers College of Nursing Ellen McCreedy, PhD, MPH Brown University School of Public Health Jessica Colburn, MD Johns Hopkins University […]

  • Fri 22

    Grand Rounds January 22: Is It Time to Embrace Preprints? A Conversation About the First 18 Months of medRxiv

    January 22, 2021 @ 1:00 pm - 2:00 pm

    Speakers: Harlan M. Krumholz, MD, SM Harold H. Hines, Jr. Professor of Medicine and Public Health Yale University Joseph S. Ross, MD, MHS Professor of Medicine and Public Health Yale […]

  • Fri 29

    Grand Rounds January 29: The COVID-19 Citizen Science Study

    January 29, 2021 @ 1:00 pm - 2:00 pm

    Speaker: Gregory M. Marcus, MD, MAS Professor of Medicine University of California, San Francisco Topic: The COVID-19 Citizen Science Study Date: Friday, January 29, 2021, 1:00-2:00 p.m. ET Meeting Info: […]

  • February 2021

  • Fri 5

    Grand Rounds February 5: Generating High-Quality Evidence During a Pandemic: The Brazilian COALITION Experience

    February 5, 2021 @ 1:00 pm - 2:00 pm

    Speaker: Renato D. Lopes, MD, MHS, PhD Professor of Medicine Division of Cardiology Duke University Medical Center Duke Clinical Research Institute Brazilian Clinical Research Institute Topic: Generating High-Quality Evidence During […]

  • Fri 12

    Grand Rounds February 12: Leveraging RWD in a Multinational Trial: Results from the Other eHARMONY (HARMONY Outcomes EHR Ancillary Study)

    February 12, 2021 @ 1:00 pm - 2:00 pm

    Speakers: Lesley Curtis, PhD Professor in Population Health Sciences Department of Population Health Sciences Duke University School of Medicine Brad Hammill, PhD Associate Professor in Population Health Sciences Department of […]

  • Thu 18

    NIA IMPACT Collaboratory Grand Rounds February 18: Ethical Challenges with Pragmatic RCTs – General Issues and Special Considerations in Dementia

    February 18, 2021 @ 12:00 pm - 1:00 pm

    Presenter: Stuart G. Nicholls, PhD Senior Clinical Research Associate Ottawa Hospital Research Institute Zoom Details: Please click the link below to join the webinar: https://hebrewseniorlife.zoom.us/j/97344810673 Webinar ID: 973 4481 0673 […]

  • Fri 19

    Grand Rounds February 19: Beyond Politics: Promoting COVID Vaccination in the US

    February 19, 2021 @ 1:00 pm - 2:00 pm

    Speaker: Kevin A. Schulman, MD Professor of Medicine and Economics Stanford University Topic: Beyond Politics: Promoting COVID Vaccination in the US Date: Friday, February 19, 2021, 1:00-2:00 pm ET Meeting […]

  • Fri 26

    Grand Rounds February 26: Calibrating Real-World Evidence Against RCT Evidence: Early Learnings from RCT-DUPLICATE

    February 26, 2021 @ 1:00 pm - 2:00 pm

    Speaker: Sebastian Schneeweiss, MD, ScD Chief, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital Professor of Medicine, Harvard Medical School Professor in Epidemiology, Harvard T.H. Chan School of Public […]

  • March 2021

  • Fri 5

    Grand Rounds March 5: Data and Safety Monitoring Boards for Trials of COVID-19 Vaccines: The Challenges

    March 5, 2021 @ 1:00 pm - 2:00 pm

    Speaker: Susan S. Ellenberg, PhD Professor of Biostatistics, Medical Ethics, and Health Policy University of Pennsylvania Topic: Data and Safety Monitoring Boards for Trials of COVID-19 Vaccines: The Challenges Date: […]

  • Fri 12

    Grand Rounds March 12: Lessons Learned from the Gates MRI Virtual COVID-19 Trial

    March 12, 2021 @ 1:00 pm - 2:00 pm

    Speakers: Mohamed Bassyouni, PharmD Product Development Program Leader Bill and Melinda Gates Medical Research Institute Cambridge, MA Jintanat Ananworanich, MD, PhD Clinical Development Leader Bill and Melinda Gates Medical Research […]

  • Thu 18

    NIA IMPACT Collaboratory Grand Rounds March 18: Updates on the IMPACT Pilot Studies

    March 18, 2021 @ 12:00 pm - 1:00 pm

    Presenters: Brent P. Forester, MD, MSc Chief, Center of Excellence in Geriatric Psychiatry McLean Hospital Medical Director, Behavioral Health, Evaluation, and Research Population Health Management Mass General Brigham Ula Hwang, MD, MPH Professor of Emergency Medicine Yale School of Medicine Zoom Details: Please click the link below to join the webinar: https://hebrewseniorlife.zoom.us/j/97344810673 Webinar ID: 973 […]

  • Fri 19

    Grand Rounds March 19: HERO–Learning Together about Vaccines for SARS-CoV-2

    March 19, 2021 @ 1:00 pm - 2:00 pm

    Speakers: Emily O’Brien, PhD, FAHA Associate Professor Duke Clinical Research Institute Duke University School of Medicine Robert M. Califf, MD, MACC Head of Clinical Policy and Strategy Verily Life Sciences […]

  • Fri 26

    Grand Rounds March 26: The Path to Preventive Genomics

    March 26, 2021 @ 1:00 pm - 2:00 pm

    Speaker: Robert C. Green, MD, MPH Professor of Medicine (Genetics), Harvard Medical School Director, Genomes2People Research Program and Preventive Genomics Clinic Mass General Brigham, Ariadne Labs, Broad Institute Topic: The Path […]

  • April 2021

  • Fri 2

    Grand Rounds April 2: Lessons from COVID-19: The First Year of the REMAP-CAP Global Adaptive Platform Trial

    April 2, 2021 @ 1:00 pm - 2:00 pm

    Speaker: Derek C. Angus, MD, MPH, FRCP Chief Healthcare Innovation Officer, UPMC Associate Vice Chancellor for Healthcare Innovation, University of Pittsburgh Schools of the Health Sciences Distinguished Professor and Mitchell […]

  • Fri 9

    Grand Rounds April 9: Taking Research to the Participant: Experiences with TREAT NOW, a No-Touch COVID-19 Trial

    April 9, 2021 @ 1:00 pm - 2:00 pm

    Speaker: Adit Ginde, MD, MPH Professor and Vice Chair for Research, Department of Emergency Medicine Director of Clinical Research, Department of Anesthesiology Director, Colorado CTSI Trial Innovation Network Hub University […]

  • Thu 15

    NIA IMPACT Collaboratory Grand Rounds April 15: Inclusion, Diversity, and Equity in Pragmatic Clinical Trials

    April 15, 2021 @ 12:00 pm - 1:00 pm

    Presenters: Consuelo H. Wilkins, MD, MSCI Vice President for Health Equity Vanderbilt University Medical Center Professor of Medicine Vanderbilt School of Medicine Zoom Details: Please click the link below to join the webinar: https://hebrewseniorlife.zoom.us/j/97344810673 Webinar ID: 973 4481 0673 International numbers available: https://hebrewseniorlife.zoom.us/u/ac4bYFtynq

  • Fri 16

    Grand Rounds April 16: Minnesota EHR Consortium COVID-19 Project: A Statewide Collaboration to Inform Vaccine Equity

    April 16, 2021 @ 1:00 pm - 2:00 pm

    Speakers: Paul E. Drawz, MD, MHS, MS Associate Professor Division of Renal Disease and Hypertension University of Minnesota Tyler N.A. Winkelman, MD, MSc Co-Director, Health, Homelessness, and Criminal Justice Lab […]

  • Fri 23

    Grand Rounds April 23: COVID Clinical Trials: The Intermountain Healthcare Experience

    April 23, 2021 @ 1:00 pm - 2:00 pm

    Speaker: Samuel M. Brown, MD, MS Associate Professor and Director of Pulmonary/Critical Care Research Intermountain Healthcare Associate Professor, University of Utah Topic: COVID Clinical Trials: The Intermountain Healthcare Experience Date: […]

  • Fri 30

    Grand Rounds April 30: ACTIV-6: A Direct-to-Participant Platform Trial of Repurposed Drugs for COVID-19 in Non-hospitalized Patients

    April 30, 2021 @ 1:00 pm - 2:00 pm

    Speakers: Susanna Naggie, MD, MHS Associate Professor of Medicine Duke Clinical Research Institute Elizabeth Shenkman, PhD Chair, Department of Health Outcomes and Biomedical Informatics Co-Director, Clinical and Translational Science Institute […]

  • May 2021

  • Fri 7

    Grand Rounds May 7: Online Recruitment in the Era of COVID-19: Pitfalls and Progress

    May 7, 2021 @ 1:00 pm - 2:00 pm

    Speaker: Megan L. Ranney, MD, MPH, FACEP Director, Brown-Lifespan Center for Digital Health Warren Alpert Endowed Associate Professor of Emergency Medicine, Brown University Associate Dean of Strategy and Innovation, School […]

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