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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
83 events found.

Events

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  • May 2019

  • Fri 24

    Grand Rounds May 24: No Presentation (Memorial Day Holiday)

    May 24, 2019 @ 1:00 pm - 2:00 pm
  • Fri 31

    Grand Rounds May 31: Adapting Clinical Trial Design to Meet the Needs of Learning Health Systems

    May 31, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Harriette G.C. Van Spall, MD, MPH, FRCPC Associate Professor of Medicine Department of Medicine, Division of Cardiology Department of Health Research Methods, Evidence, and Impact McMaster University Population Health […]

  • June 2019

  • Fri 7

    Grand Rounds June 7: In Dreams Begin Responsibilities: Data Science as a Service—Using AI to Risk Stratify a Medicare Population and Build a Culture

    June 7, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Erich S. Huang, MD, PhD Co-Director, Duke Forge Departments of Biostatistics & Bioinformatics and Surgery Duke University School of Medicine Topic: In Dreams Begin Responsibilities: Data Science as a Service—using […]

  • Fri 14

    Grand Rounds June 14: Good Clinical Practice Guidance and Pragmatic Trials: Balancing the Best of Both Worlds in the Learning Health System

    June 14, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Robert J. Mentz, MD, FACC, FAHA, FHFSA Associate Professor Director, Duke Cooperative Cardiovascular Society Associate Program Director, Duke Cardiovascular Disease Fellowship Duke University Medical Center and Duke Clinical Research […]

  • Fri 21

    Grand Rounds June 21: A Polypill Strategy for Cardiovascular Prevention in Underserved Populations – Can We Bridge the Gap?

    June 21, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Daniel Muñoz, MD, MPA Assistant Professor of Medicine Division of Cardiology Vanderbilt University Medical Center Thomas J. Wang, MD Professor of Medicine Gottlieb C. Friesinger II Chair in Cardiovascular […]

  • Fri 28

    Grand Rounds June 28: Moving Beyond Return of Research Results to Return of Value

    June 28, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Consuelo H. Wilkins, MD, MSCI Vice President for Health Equity, Vanderbilt University Medical Center Executive Director, Meharry-Vanderbilt Alliance Topic: Moving Beyond Return of Research Results to Return of Value Date: […]

  • July 2019

  • Fri 5

    Grand Rounds July 5: No Presentation (Independence Day Holiday)

    July 5, 2019 @ 1:00 pm - 2:00 pm
  • Fri 12

    Grand Rounds July 12: medRxiv: A Paradigm Shift in Disseminating Clinical and Public Health Research

    July 12, 2019 @ 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 Associate Professor of Medicine and Public Health […]

  • Fri 19

    Grand Rounds July 19: Misinformation as a Source of Complication for Clinical Trials

    July 19, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Brian Southwell, PhD Senior Director, Science in the Public Sphere, RTI International Duke-RTI Scholar, Duke Forge, Duke University Topic: Misinformation as a Source of Complication for Clinical Trials Date: Friday, July 19, […]

  • Fri 26

    Grand Rounds July 26: Digital in Trials: Improving Participation and Enabling Novel Endpoints

    July 26, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Craig H. Lipset Former Head of Clinical Innovation Pfizer Topic: Digital in Trials: Improving Participation and Enabling Novel Endpoints Date: Friday, July 26, 2019, 1:00-2:00 p.m. ET Meeting Info: […]

  • August 2019

  • Fri 2

    Grand Rounds August 2, 2019: AI and the Future of Psychiatry

    August 2, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Murali Doraiswamy Professor of Psychiatry and Behavioral Sciences Duke School of Medicine Topic: AI and the Future of Psychiatry Date: Friday, August 2, 2019, 1:00-2:00 p.m. ET Meeting Info: […]

  • Fri 9

    Grand Rounds August 9: Open Science: Are we there yet?

    August 9, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Adrian Hernandez, MD Professor of Medicine Vice Dean for Clinical Research Duke University, School of Medicine Topic: Open Science: Are we there yet? Date: Friday, August 9, 2019, 1:00-2:00 […]

  • Fri 16

    Grand Rounds August 16: Introducing the Digital Medicine Society (DiMe)

    August 16, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Andy Coravos CEO, Elektra Labs Fellow, Harvard-MIT Center for Regulatory Science Co-founder, Digital Medicine Society (DiMe) Jen Goldsack Interim Executive Director, DiMe Portfolio, Strategy & Ops, HealthMode Topic: Introducing […]

  • Fri 23

    Grand Rounds August 23: Oh yes, we have tons of patients who can do this study!

    August 23, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Vanita R. Aroda, MD Director of Diabetes Clinical Research Brigham & Women’s Hospital Harvard Medical School Topic: Oh yes, we have tons of patients who can do this study! […]

  • Fri 30

    Grand Rounds August 30: No Presentation (Labor Day Holiday)

    August 30, 2019 @ 1:00 pm - 2:00 pm
  • September 2019

  • Fri 6

    Grand Rounds September 6: Transforming Medical Evidence Generation with Technology-Enabled Trials

    September 6, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Matthew T. Roe, MD, MHS Senior Investigator, Professor of Medicine Duke Clinical Research Institute Topic: Transforming Medical Evidence Generation with Technology-Enabled Trials Date: Friday, September 6, 2019, 1:00-2:00 p.m. […]

  • Fri 13

    Grand Rounds September 13: ADAPTABLE Recruitment and Follow-up: Health Plan Research Network Engagement

    September 13, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Kevin Haynes, PharmD, MSCE Principal Scientist HealthCore, Inc. Topic: ADAPTABLE Recruitment and Follow-up: Health Plan Research Network Engagement Date: Friday, September 13, 2019, 1:00-2:00 p.m. ET Meeting Info: To […]

  • Fri 20

    Grand Rounds September 20: Designing & Testing the Future of Home-based Cervical Cancer Screening: Results from a Collaborative Academic-Embedded Delivery System Pragmatic Randomized Trial

    September 20, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Rachel L. Winer, PhD University of Washington School of Public Health Department of Epidemiology Diana S.M. Buist, PhD, MPH Kaiser Permanente Washington Health Research Institute Topic: Designing & testing […]

  • Fri 27

    Grand Rounds September 27: Preparing for Clinical Trial Data Sharing and Re-use: The New Reality for Researchers

    September 27, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Rebecca Li, PhD Executive Director, Vivli Co-Director of Research Ethics, Harvard Center for Bioethics Harvard Medical School Frank W. Rockhold, PhD Professor of Biostatistics and Bioinformatics Duke Clinical Research […]

  • October 2019

  • Fri 4

    Grand Rounds October 4: Ascertaining Death and Hospitalization Endpoints: The TRANSFORM-HF Experience

    October 4, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Eric L. Eisenstein, DBA Associate Professor in Medicine Duke University School of Medicine Kevin J. Anstrom, PhD Professor of Biostatistics and Bioinformatics Director of Biostatistics, Duke Clinical Research Institute […]

  • Fri 11

    Grand Rounds October 11: Objecting to Experiments that Compare Two Unobjectionable Policies or Treatments: Implications for Comparative Effectiveness and Other Pragmatic Clinical Trials

    October 11, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Michelle N. Meyer, PhD, JD Assistant Professor & Associate Director, Research Ethics Center for Translational Bioethics & Health Care Policy Faculty Co-Director, Behavioral Insights Team Steele Institute for Health […]

  • Fri 18

    Grand Rounds October 18: Playing with FHIR–Innovative Use Cases for the New REDCap EHR Integration Module

    October 18, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Paul A. Harris, PhD Director, Professor of Biomedical Informatics Vanderbilt University Medical Center Topic: Playing with FHIR–Innovative Use Cases for the New REDCap EHR Integration Module Date: Friday, October […]

  • Fri 25

    Grand Rounds October 25: Real-World Evidence for Drug Effectiveness Evaluation: Addressing the Credibility Gap

    October 25, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Richard Willke, PhD Chief Science Officer, ISPOR Topic: Real-World Evidence for Drug Effectiveness Evaluation: Addressing the Credibility Gap Date: Friday, October 25, 2019, 1:00-2:00 p.m. ET Meeting Info: To […]

  • November 2019

  • Fri 1

    Grand Rounds November 1: NIH Collaboratory: Looking Back and Looking Forward

    November 1, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Adrian F. Hernandez, MD, MHS Professor of Medicine Vice Dean for Clinical Research Duke University, School of Medicine Lesley H. Curtis, PhD Chair and Professor Department of Population Health […]

  • Fri 8

    Grand Rounds November 8: Lumbar Imaging with Reporting of Epidemiology: Initial Results and Some Lessons Learned

    November 8, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Jeffrey (Jerry) G. Jarvik MD MPH Professor, Radiology, Neurological Surgery and Health Services Adjunct Professor, Pharmacy and Orthopedics & Sports Medicine University of Washington Patrick Heagerty, PhD Professor and […]

  • Fri 15

    Grand Rounds November 15: PCORnet: Health Plan Research Network Data Linkage and Patient Engagement with Patient-Powered Research Networks

    November 15, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Kevin Haynes, PharmD, MSCE Principal Scientist HealthCore Topic: PCORnet: Health Plan Research Network Data Linkage and Patient Engagement with Patient-Powered Research Networks Date: Friday, November 15, 2019, 1:00-2:00 p.m. […]

  • Thu 21

    IMPACT Collaboratory: Are You Ready for a Pragmatic Trial? The RAPT Model and Implementation Considerations

    November 21, 2019 @ 12:00 pm - 1:00 pm

    Speakers: Rosa Baier, MPH Associate Director, Center for Long-Term Care Quality & Innovation Associate Professor, Health Sciences, Policy & Practice Brown University School of Medicine Eric Jutkowitz, PhD Assistant Professor […]

  • Fri 22

    Grand Rounds November 22: It’s Time to Learn From Patients Like Mine

    November 22, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Nigam H Shah, MBBS, PhD Associate Professor of Medicine Stanford University Topic: It's Time to Learn From Patients Like Mine Date: Friday, November 22, 2019, 1:00-2:00 p.m. ET Meeting […]

  • Fri 29

    Grand Rounds November 29: No Presentation (Thanksgiving Holiday)

    November 29, 2019 @ 1:00 pm - 2:00 pm
  • December 2019

  • Fri 6

    Grand Rounds December 6: Millions More People, Stronger Collaborations: The New and Improved NIH Collaboratory Distributed Research Network

    December 6, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Richard Platt, MD, MS Professor and Chair Harvard Medical School Department of Population Medicine Kevin Haynes, PharmD, MSCE Principal Scientist HealthCore Denise Boudreau, PhD Senior Scientific Investigator Kaiser Permanente […]

  • Fri 13

    Grand Rounds December 13: EMBED Update: Challenges and Solutions

    December 13, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Edward R. Melnick, MD, MHS Assistant Professor of Emergency Medicine Program Director, Yale-VA Clinical Informatics Fellowship Program Principal Investigator, EMBED Trial Gail D’Onofrio, MD Professor & Chair Department of […]

  • Thu 19

    IMPACT Collaboratory Grand Rounds December 19: Stepped wedge cluster trials: what, how, and when?

    December 19, 2019 @ 12:00 pm - 1:00 pm

    Speakers:  Monica Taljaard, PhD Senior Scientist, Ottawa Hospital Research Institute Associate Professor, University of Ottawa Topic:  Stepped wedge cluster trials: what, how, and when? Date: Thursday, December 19, 2019, 12:00-1:00 […]

  • Fri 20

    Grand Rounds December 20: No Presentation (Holiday Break)

    December 20, 2019 @ 1:00 pm - 2:00 pm
  • Fri 27

    Grand Rounds December 27: No Presentation (Week of Christmas Holiday)

    December 27, 2019 @ 1:00 pm - 2:00 pm
  • January 2020

  • Fri 3

    Grand Rounds January 3: No Presentation (New Year’s Holiday)

    January 3, 2020 @ 1:00 pm - 2:00 pm
  • Fri 10

    Grand Rounds January 10: Pragmatic Trials of Behavioral Economic Interventions to Increase Colorectal Cancer Screening

    January 10, 2020 @ 1:00 pm - 2:00 pm

    Speaker: Shivan Mehta, MD, MBA, MSHP Assistant Professor of Medicine and Health Policy University of Pennsylvania Topic: Pragmatic Trials of Behavioral Economic Interventions to Increase Colorectal Cancer Screening Date: Friday, […]

  • Fri 17

    Grand Rounds January 17: Assessment of the Human Systemic Absorption of Sunscreen Active Ingredients: FDA-Sponsored Randomized Clinical Trial

    January 17, 2020 @ 1:00 pm - 2:00 pm

    Speaker: Murali Matta, MPharm, PhD Bioanalytical Lead Division of Applied Regulatory Science Office of Clinical Pharmacology Food and Drug Administration Topic: Assessment of the Human Systemic Absorption of Sunscreen Active […]

  • Thu 23

    IMPACT Collaboratory Grand Rounds January 23: Using a Pilot to Test and Refine Your Measurement Strategy

    January 23, 2020 @ 12:00 pm - 1:00 pm

    Speakers:  Ellen McCreedy, PhD, MPH Assistant Professor, Brown University School of Public Health Topic: Using a Pilot to Test and Refine Your Measurement Strategy Date: Thursday, January 23, 2020, 12:00-1:00 […]

  • Fri 24

    Grand Rounds January 24: Cardiovascular Trials Over 2 Decades: Progress on Pragmatism?

    January 24, 2020 @ 1:00 pm - 2:00 pm

    Speaker: Justin A. Ezekowitz, MBBCh, MSc Professor, Department of Medicine Co-Director, Canadian VIGOUR Centre Director, Cardiovascular Research, University of Alberta Cardiologist, Mazankowski Alberta Heart Institute Topic: Cardiovascular Trials Over 2 Decades: […]

  • Fri 31

    Living Textbook Grand Rounds Series January 31: Part 1-Pragmatic Clinical Trials: How Do I Start?

    January 31, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Greg Simon, MD, MPH Senior Investigator Kaiser Permanente Washington Health Research Institute Lesley H. Curtis, PhD Chair and Professor Department of Population Health Sciences Duke University School of Medicine Interim Executive Director, Duke Clinical Research Institute Topic: Part 1-Pragmatic Clinical Trials: How Do I Start? Date: Friday, January 31, 2020, 1:00-2:00 p.m. ET Meeting […]

  • February 2020

  • Fri 7

    Grand Rounds February 7: Using Nudges to Improve the Delivery of Health Care

    February 7, 2020 @ 1:00 pm - 2:00 pm

    Speaker: Mitesh S. Patel, MD, MBA Ralph Muller Presidential Assistant Professor Perelman School of Medicine & Wharton School University of Pennsylvania Director, Penn Medicine Nudge Unit Topic: Using Nudges to Improve the Delivery of Health Care Date: Friday, February 7, 2020, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed […]

  • Fri 14

    Grand Rounds February 14: Do Our Current Research Models Meet the Needs of a Learning Health Care System?

    February 14, 2020 @ 1:00 pm - 2:00 pm

    Speaker: David Atkins, MD, MPH Director, Health Services Research and Development Office of Research and Development Department of Veterans Affairs Topic: Do Our Current Research Models Meet the Needs of a Learning Health Care System? Date: Friday, February 14, 2020, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for […]

  • Thu 20

    IMPACT Collaboratory Grand Rounds February 20: Modifications and waivers of informed consent in pragmatic clinical trials

    February 20, 2020 @ 12:00 pm - 1:00 pm

    Speakers:  Jason Karlawish, MD Professor of Medicine, Medical Ethics and Health Policy, and Neurology Co-Director, Penn Memory Center, University of Pennsylvania IMPACT Regulation and Ethics Core Leader Topic: Modifications and waivers of informed consent in pragmatic clinical trials Date: Thursday, February 20, 2020, 12:00-1:00 p.m. ET To join the online meeting:  Go to: https://hebrewseniorlife.zoom.us/j/5479652617  Dial-In: […]

  • Fri 21

    Grand Rounds February 21: Nudge Study Updates

    February 21, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Michael Ho, MD, PhD Professor of Medicine, University of Colorado School of Medicine Staff Cardiologist, Rocky Mountain Regional VA Medical Center Sheana Bull, PhD, MPH Professor, Colorado School of Public Health Director, mHealth Impact Laboratory Topic: Nudge Study Updates Date: Friday, February 21, 2020, 1:00-2:00 p.m. ET Meeting Info: To check whether you have […]

  • Fri 28

    Living Textbook Grand Rounds Series February 28: Part 2-Preparing for the Unknown: Conducting Pragmatic Research in Real-World Contexts

    February 28, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Vincent Mor, PhD Florence Pirce Grant University Professor Department of Health Services Policy & Practice Brown University School of Public Health Leah Tuzzio, MPH Research Associate Kaiser Permanente Washington Health Research Institute Jeffrey (Jerry) G. Jarvik MD, MPH Professor, Radiology, Neurological Surgery and Health Services Adjunct Professor, Pharmacy and Orthopedics & Sports Medicine University […]

  • March 2020

  • Fri 6

    Grand Rounds March 6: Creating a Learning Health System Through Randomization

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

    Speaker: Leora Horwitz, MD, MHS Associate Professor, Population Health and Medicine Director, Center for Healthcare Innovation and Delivery Science, NYU Langone Health Director, Division of Healthcare Delivery Science, Department of Population Health, NYU Grossman School of Medicine Topic: Creating a Learning Health System Through Randomization Date: Friday, March 6, 2020, 1:00-2:00 p.m. ET Meeting Info: […]

  • Fri 13

    Grand Rounds March 13: Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus–Lessons Learned and Future Directions

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

    Speakers: Abhinav Sharma, MD, PhD Assistant Professor of Medicine McGill University Christopher B. Granger, MD, FAHA, FACC Professor of Medicine Director, Cardiac Intensive Care Unit Duke University Medical Center Topic: Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus – Lessons Learned and Future Directions Date: […]

  • Thu 19

    NIH Workshop March 19-20: Developing Meaningful Endpoints for Pain Clinical Trials

    March 19, 2020 @ 8:00 am - March 20, 2020 @ 5:00 pm

    Meeting Name: Developing Meaningful Endpoints for Pain Clinical Trials Meeting Dates: Thursday, March 19, 2020 to Friday, March 20, 2020 Location:  Bethesda Marriott Bethesda, Maryland United States Registration Date(s): Monday, January 27, 2020 to Thursday, March 19, 2020 How to attend: The workshop can be attended virtually through the following link: https://meetings.ninds.nih.gov/?ID=26519.  

  • Fri 20

    Grand Rounds March 20: Clinical Trials in the Time of COVID-19

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

    Speakers: Susanna Naggie, MD Associate Dean for Clinical Research Initiatives and Regulatory Affairs Duke University School of Medicine Adrian F. Hernandez, MD, MHS Professor of Medicine Vice Dean for Clinical Research Duke University School of Medicine Eric Perakslis, PhD Rubenstein Fellow Duke University Topic: Clinical Trials in the Time of COVID-19 Date: Friday, March 20, […]

  • Fri 27

    Living Textbook Grand Rounds Series March 27: Part 3-Tips for Putting Together a Successful PCT Grant Application

    March 27, 2020 @ 1:00 pm - 2:00 pm

    Speaker: Wendy Weber, ND, PhD, MPH Branch Chief, Clinical Research Branch Division of Extramural Research, NCCIH Topic: Part 3-Tips for Putting Together a Successful PCT Grant Application Date: Friday, March 27, 2020, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go […]

  • April 2020

  • Fri 3

    Grand Rounds April 3: Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): Participant-Centered, Rapidly-Deployed, Digitally-Enabled Research

    April 3, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Harlan M. Krumholz, MD Harold H. Hines Jr. Professor of Medicine, Yale University Director, Yale New Haven Hospital Center for Outcomes Research and Evaluation Co-Founder Hugo Health Bala Hota, MD, MPH Professor of Internal Medicine, Rush University Chief Analytics Officer, Rush University Medical Center Graham Nichol, MD, MPH Medic One Foundation Endowed Chair for […]

  • Fri 10

    Grand Rounds April 10: Hydroxychloroquine for the Early Treatment of COVID-19 in Hospitalized Adults: A Multicenter Randomized Clinical Trial

    April 10, 2020 @ 1:00 pm - 2:00 pm

    Speaker: Sean Collins, MD, MSc Professor and Executive Vice Chair Department of Emergency Medicine Director, Center for Emergency Care Research and Innovation Vanderbilt University Medical Center Topic: Hydroxychloroquine for the Early Treatment of COVID-19 in Hospitalized Adults: A Multicenter Randomized Clinical Trial Date: Friday, April 10, 2020, 1:00-2:00 p.m. ET Meeting Info: To check whether […]

  • Fri 17

    Grand Rounds April 17: The HERO Program: PCORnet® at Work to Create a Healthcare Worker Community for Rapid Cycle Evidence

    April 17, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Nakela Cook, MD, MPH Executive Director PCORI Josie Briggs, MD Acting Chief Science Director PCORI Susanna Naggie, MD Principal Investigator, HERO-HCQ Clinical Trial Duke University Emily O’Brien, PhD Principal Investigator, HERO-Registry Duke University Russell Rothman, MD, MPP Chair, HERO Steering Committee Vanderbilt University Chris Forrest, MD, PhD Chair, HERO Registry Children’s Hospital of Pennsylvania […]

  • Fri 24

    Grand Rounds April 24: The RECOVERY Trial: A UK National Platform Trial of Potential Treatments for Patients Hospitalised with COVID-19

    April 24, 2020 @ 1:00 pm - 2:00 pm

    Speaker: Martin Landray, PhD, FRCP Professor of Medicine & Epidemiology Nuffield Department of Population Health University of Oxford, UK Topic: The RECOVERY Trial: A UK National Platform Trial of Potential Treatments for Patients Hospitalised with COVID-19 Date: Friday, April 24, 2020, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed […]

  • May 2020

  • Fri 1

    Grand Rounds EHR Workshop Series May 1: Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Keynote-Can the COVID-19 Crisis Lead to Reformation of the Evidence Generation Ecosystem?

    May 1, 2020 @ 1:00 pm - 2:00 pm

    Speaker: Robert Califf, MD, MACC Head of Strategy and Policy Verily Life Sciences and Google Health Topic: Advances at the Intersection of Digital Health, Electronic Health Records and Pragmatic Clinical Trials: Keynote-Can the COVID-19 Crisis Lead to Reformation of the Evidence Generation Ecosystem? Date: Friday, May 1, 2020, 1:00-2:00 p.m. ET Meeting Info: To check […]

  • Thu 7

    IMPACT Collaboratory Grand Rounds May 7: COVID-19 in Nursing Homes: Pragmatic Research Responses to the Crisis

    May 7, 2020 @ 12:00 pm - 1:00 pm

    Speakers:  David C. Grabowski, PhD Professor of Health Care Policy Department of Health Care Policy, Harvard Medical School Susan Mitchell, MD, MPH IMPACT Principal Investigator Professor of Medicine, Harvard Medical School Senior Scientist, Hebrew SeniorLife’s Hinda and Arthur Marcus Institute for Aging Research Vince Mor, PhD IMPACT Principal Investigator Florence Pirce Grant University Professor; Professor […]

  • Fri 8

    Grand Rounds EHR Workshop Series May 8: Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Real World Evidence: Contemporary Experience and Future Directions

    May 8, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Guest Moderator Patrick J. Heagerty PhD Professor, Department of Biostatistics, University of Washington Panel Jacqueline Corrigan-Curay, JD, MD Director of CDER’s Office of Medical Policy (OMP) U.S. Food and Drug Administration (FDA) Joshua C. Denny, MD, MS, FACMI Chief Executive Officer, All of Us Research Program, NIH Topic: Advances at the Intersection of Digital […]

  • Fri 15

    Grand Rounds May 15: Optimizing Learning While Doing: The REMAP-CAP Adaptive Platform Trial

    May 15, 2020 @ 1:00 pm - 2:00 pm

    Speaker: Derek C. Angus, MD, MPH, FRCP Distinguished Professor and Mitchell P. Fink Endowed Chair Department of Critical Care Medicine University of Pittsburgh and UPMC Health System Topic: Optimizing Learning While Doing: The REMAP-CAP Adaptive Platform Trial Date: Friday, May 15, 2020, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players […]

  • Thu 21

    IMPACT Collaboratory Grand Rounds May 21: Stakeholder Engagement in ePCTs for People Living with Dementia

    May 21, 2020 @ 12:00 pm - 1:00 pm

    Speaker:  Ellen Tambor, MA Research Director, Center for Medical Technology Policy Executive Committee Member, IMPACT Stakeholder Engagement Team Topic: Stakeholder Engagement in ePCTs for People Living with Dementia Date: Thursday, May 21, 2020, 12:00-1:00 p.m. ET To join the online meeting:  Go to: https://hebrewseniorlife.zoom.us/j/5479652617  Dial-In: +1 646 876 9923 (US Toll) or +1 669 900 […]

  • Fri 22

    Grand Rounds May 22: No Presentation (Memorial Day Holiday)

    May 22, 2020 @ 1:00 pm - 2:00 pm
  • Fri 29

    Grand Rounds EHR Workshop Series May 29: Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Experiences from the Collaboratory PCTs

    May 29, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Guest Moderator Wendy Weber, ND, PhD, MPH Branch Chief, Clinical Research in Complementary and Integrative Health Division of Extramural Research National Center for Complementary and Integrative Health, NIH Panel Jeffrey (Jerry) G. Jarvik, MD, MPH LIRE NIH Collaboratory Trial Professor of Radiology, Neurological Surgery and Health Services Adjunct Professor of Pharmacy and Orthopedics & Sports Medicine […]

  • June 2020

  • Fri 5

    Grand Rounds June 5: PCORnet COVID-19 Common Data Model Design and Results

    June 5, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Thomas W. Carton, PhD, MS Chief Data Officer Louisiana Public Health Institute Keith Marsolo, PhD Associate Professor Department of Population Health Sciences Duke Clinical Research Institute Duke University School of Medicine Jason Perry Block, MD, MPH Associate Professor of Population Medicine Department of Population Medicine Harvard Pilgrim Health Care Institute Harvard Medical School Topic: […]

  • Fri 12

    Grand Rounds June 12: A Cluster Randomized Pragmatic Trial of an Advance Care Planning Video Intervention in Long-Stay Nursing Home Residents: Main Findings from the PROVEN Trial

    June 12, 2020 @ 1:00 pm - 2:00 pm

    Speaker: Susan L. Mitchell MD, MPH Senior Scientist Hebrew SeniorLife Hinda and Arthur Marcus Institute for Aging Research Professor of Medicine Harvard Medical School Topic: A Cluster Randomized Pragmatic Trial of an Advance Care Planning Video Intervention in Long-Stay Nursing Home Residents: Main Findings from the PROVEN Trial Date: Friday, June 12, 2020, 1:00-2:00 p.m. […]

  • Fri 19

    Living Textbook Grand Rounds Series June 19: Part 4-Demystifying Biostatistical Concepts for Embedded Pragmatic Clinical Trials

    June 19, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Elizabeth Turner, PhD Associate Professor Department of Biostatistics & Bioinformatics and Duke Global Health Institute Duke University Patrick Heagerty, PhD Professor Department of Biostatistics University of Washington David Murray, PhD Associate Director for Prevention Director, Office of Disease Prevention National Institutes of Health Topic: Part 4-Demystifying Biostatistical Concepts for Embedded Pragmatic Clinical Trials Date: […]

  • Fri 26

    Grand Rounds EHR Workshop Series June 26: Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Keys to Success in the Evolving EHR Environment

    June 26, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Guest Moderator Keith Marsolo, PhD Associate Professor, Population Health Sciences Duke University Panel Teresa Zayas-Cabán, PhD Chief Scientist Office of the National Coordinator for Health Information Technology Office of the Secretary, DHHS George (Holt) Oliver, MD, PhD Vice President Clinical Informatics Parkland Center for Clinical Innovations Christopher A. Longhurst, MD, MS CIO and Associate […]

  • July 2020

  • Fri 3

    Grand Rounds July 3: No Presentation (Independence Day Holiday)

    July 3, 2020 @ 1:00 pm - 2:00 pm
  • Fri 10

    Grand Rounds July 10: COVID Open Science Collaborative Analytics Platform: National COVID Cohort Collaborative (N3C)

    July 10, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Ken Gersing, MD Director of Informatics, NCATS National Institutes of Health Robert A. Star, MD Director, Division of Kidney, Urologic, and Hematologic Disorders, NIDDK Chief, Renal Diagnostics and Therapeutics Unit, NIDDK National Institutes of Health Topic: COVID Open Science Collaborative Analytics Platform: National COVID Cohort Collaborative (N3C) Date: Friday, July 10, 2020, 1:00-2:00 p.m. […]

  • Tue 14

    Methods: Mind the Gap Webinar July 14: Overview of Statistical Models for the Design and Analysis of Stepped Wedge Cluster Randomized Trials

    July 14, 2020 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker:  Fan Li, PhD Yale University School of Public Health Description: The stepped-wedge cluster randomized design has received increasing attention in pragmatic clinical trials (PCTs) and implementation science research. Since the design's introduction, a variety of mixed-effects model extensions have been proposed for the design and analysis of PCTs. In this talk, Dr. Fan Li […]

  • Thu 16

    IMPACT Collaboratory Grand Rounds July 16: Breaking the Cycle: Health Care Systems Interactions for Impactful Results

    July 16, 2020 @ 12:00 pm - 1:00 pm

    Speakers:  Leah Hanson, PhD Senior Research Investigator, Senior Director of Research at HealthPartners Neuroscience Center, Health Partners Institute Co-Director of Research, HealthPartners Center for Memory and Aging Eric Larson, MD, MPH Vice President, Research and Health Care Innovation, Kaiser Foundation Health Plan of Washington Executive Director and Senior Investigator, Kaiser Washington Health Research Institute David […]

  • Fri 17

    Living Textbook Grand Rounds Series July 17: Part 5-Choosing What to Measure and Making it Happen: Your Keys to Pragmatic Trial Success

    July 17, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Rachel Richesson, PhD, MPH Associate Professor, Informatics Duke University School of Nursing Devon Check, PhD Assistant Professor, Population Health Sciences Department of Population Health Topic: Part 5-Choosing What to Measure and Making it Happen: Your Keys to Pragmatic Trial Success Date: Friday, July 17, 2020, 1:00-2:00 p.m. ET Meeting Info: To check whether you […]

  • Fri 24

    Grand Rounds July 24: TENS in Fibromyalgia: From Fundamental Neurobiology to Pragmatic Trial

    July 24, 2020 @ 1:00 pm - 2:00 pm

    Speaker: Leslie J. Crofford, MD Wilson Family Chair and Professor of Medicine Vanderbilt University Medical Center Topic: TENS in Fibromyalgia: From Fundamental Neurobiology to Pragmatic Trial Date: Friday, July 24, 2020, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to […]

  • Fri 31

    Grand Rounds July 31: Using Real-World Data to Plan Eligibility Criteria and Enhance Recruitment: Actionable Recommendations and Resources from the Clinical Trials Transformation Initiative

    July 31, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Sudha Raman, PhD, MA Assistant Professor Department of Population Health Sciences Duke University John Sheehan, PhD, MBA, RPh Senior Director, Value and Evidence (HEOR) Neuroscience Janssen Scientific Affairs, LLC Topic: Using Real-World Data to Plan Eligibility Criteria and Enhance Recruitment: Actionable Recommendations and Resources from the Clinical Trials Transformation Initiative Date: Friday, July 31, […]

  • Fri 31

    July 31, 2020: NIA IMPACT Collaboratory to Present at Alzheimer’s Association International Conference

    July 31, 2020 @ 2:00 pm - 4:00 pm

    The IMPACT Collaboratory will have a strong presence at the upcoming Alzheimer’s Association International Conference (AAIC). NIA IMPACT Embedded Pragmatic Clinical Trials (ePCTs) for the Improvement of Care for People Living with Dementia (PLWD) and their Care Partners features IMPACT members: Vince Mor, PhD, Laura Hanson, MD, MPH, Jason Karlawish, MD, and Fan Li, PhD, […]

  • August 2020

  • Fri 7

    Grand Rounds August 7: The Democratization of Medicine: Open Access, Social Media, AI, Apps, and Empowering the Patient as the Future of Clinical Research

    August 7, 2020 @ 1:00 pm - 2:00 pm

    Speaker: C. Michael Gibson, MS, MD Professor of Medicine Harvard Medical School President and CEO Baim and PERFUSE Research Institutes Topic: The Democratization of Medicine: Open Access, Social Media, AI, Apps, and Empowering the Patient as the Future of Clinical Research Date: Friday, August 7, 2020, 1:00-2:00 p.m. ET Meeting Info: To check whether you […]

  • Tue 11

    August 11-12, 2020: Colorado Pragmatic Research in Health 2020 Virtual Conference

    August 11, 2020 - August 12, 2020

    The Colorado Pragmatic Research in Health (COPRH) announces its inaugural conference, offering more than 26 hours of presentations with real-time Q&A and focused discussions about methods, models, and measures for planning pragmatic research. Designed for clinical and translational investigators, including statisticians, dissemination and implementation scientists, health services and public health researchers, and program evaluators, COPRH […]

  • Fri 14

    Grand Rounds August 14: Learning While Sprinting: A One-Year Retrospective from the NOHARM Pragmatic Trial

    August 14, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Jon Tilburt, MD Professor of Medicine and Biomedical Ethics Mayo Clinic Andrea Cheville, MD Professor of Physical Medicine and Rehabilitation Mayo Clinic Topic: Learning While Sprinting: A One-Year Retrospective from the NOHARM Pragmatic Trial Date: Friday, August 14, 2020, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for […]

  • Fri 21

    Grand Rounds August 21: Adaptive Platform Trials: Scalable from Breast Cancer to COVID

    August 21, 2020 @ 1:00 pm - 2:00 pm

    Speaker: Laura Esserman, MD, MBA Director, UCSF Carol Franc Buck Breast Care Center Alfred A. de Lorimier Endowed Chair in General Surgery Professor of Surgery and Radiology, UCSF Topic: Adaptive Platform Trials: Scalable from Breast Cancer to COVID Date: Friday, August 21, 2020, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate […]

  • Fri 28

    Grand Rounds August 28: Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Clinical Trials: Proceedings from a Multi-Stakeholder Think Tank Meeting

    August 28, 2020 @ 1:00 pm - 2:00 pm

    Speakers: Lesley Curtis, PhD Chair and Professor, Department of Population Health Sciences Duke University School of Medicine Trevor Lentz, PT, PhD, MHA Assistant Professor in Orthopaedic Surgery Duke Clinical Research Institute Frank Rockhold, PhD, ScM, FASA, FSCT Professor of Biostatistics and Bioinformatics Duke Clinical Research Institute Topic: Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic […]

  • September 2020

  • Fri 4

    Grand Rounds September 4: No Presentation (Labor Day Holiday)

    September 4, 2020 @ 1:00 pm - 2:00 pm
  • Fri 11

    Grand Rounds September 11: Launching CONNECTS: Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies

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

    Speakers: Gordon R. Bernard, MD CONNECTS ACC Science Unit P Professor of Medicine Executive Vice President for Research Senior Associate Dean for Clinical Science Vanderbilt University Medical Center Sonia Thomas, DrPH CONNECTS ACC Principal Investigator Senior Research Statistician RTI International Topic: Launching CONNECTS (Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies): A Partnership […]

  • Wed 16

    September 16-17: PCORI 2020 Virtual Annual Meeting – Accelerating Impact on Care and Patient-Centered Outcomes

    September 16, 2020 - September 17, 2020

    Registration is now open for PCORI's sixth Annual Meeting, Accelerating Impact on Care and Patient-Centered Outcomes, being held virtually September 16-17. Join this FREE event celebrating PCORI's 10-year anniversary and discuss how to answer the research questions of the future. The meeting will highlight results from several PCORI-funded studies and explore how we can shorten […]

  • Thu 17

    September 17, 2020: NIA IMPACT Grand Rounds: Not All Approaches to Data Are Created Equal: Data-related Challenges for Pragmatic Trials Involving Patients Living With Dementia

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

    Presenters: David Dorr, MD, MS Professor & Vice-Chair of Medical Informatics and Clinical Epidemiology Professor of Medicine, Division of General Internal Medicine and Geriatrics Chief Research Information Officer, Biomedical Informatics Graduate Program Oregon Health and Science University School of Medicine V.G. Vinod Vydiswaran, PhD Assistant Professor of Learning Health Systems Assistant Professor of Information University […]

  • Fri 18

    Grand Rounds September 18: The Trauma Survivors Outcomes and Support (TSOS) Pragmatic Clinical Trial: Effectiveness and Implementation Process Assessment Results

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

    Speaker: Douglas Zatzick, MD Professor of Psychiatry and Behavioral Sciences Harborview Medical Center, University of Washington School of Medicine Topic: The Trauma Survivors Outcomes and Support (TSOS) Pragmatic Clinical Trial: Effectiveness and Implementation Process Assessment Results Date: Friday, September 18, 2020, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed […]

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