Rethinking Clinical Trials

Grand Rounds March 25: A Telehealth-Delivered Pragmatic Trial of Mindfulness for Persons with Chronic Low Back Pain (Natalia Morone, MD, MS)
2022-03-25 13:00 - 14:00 (America/New_York)
Speaker:
Natalia E. Morone, MD, MS
Associate Professor of Medicine
Boston University/Boston Medical Center

Topic: A Telehealth-Delivered Pragmatic Trial of Mindfulness for Persons with Chronic Low Back Pain
Date: Friday, March 25, 2022, 1:00-2:00 p.m. ET
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Grand Rounds April 1: ICD-Pieces: Improving Care for CKD, Diabetes and Hypertension in Health Systems (Miguel A. Vazquez, MD; George (Holt) Oliver, MD, PhD)
2022-04-01 13:00 - 14:00
Speakers:
Miguel A. Vazquez, MD
Professor of Medicine
University of Texas Southwestern Medical Center
Dallas, TX
George (Holt) Oliver, MD, PhD
Vice President Clinical Informatics
Parkland Center for Clinical Innovation
Dallas, TX

Topic: ICD-Pieces: Improving Care for CKD, Diabetes and Hypertension in Health Systems
Date: Friday, April 1, 2022, 1:00-2:00 p.m. ET
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Grand Rounds April 8: COVID-19 Surveillance in PCORnet: Year 2 Update (Jason Block, MD, MPH; Thomas W. Carton, PhD, MS)
2022-04-08 13:00 - 14:00 | https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6
Speaker:
Jason Block, MD, MPH
Associate Professor
Harvard Pilgrim Health Care Institute
Harvard Medical School
Thomas W. Carton, PhD, MS
Chief Data Officer
Louisiana Public Health Institute
Topic: COVID-19 Surveillance in PCORnet: Year 2 Update
Date: Friday, April 8, 2022, 1:00-2:00 pm ET
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Grand Rounds April 15: SODIUM-HF: Should Our Patients Consume Less Dietary Sodium? (Justin A. Ezekowitz, MBBCh, MSc)
2022-04-15 13:00 - 14:00 | https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6
Speaker:
Justin A. Ezekowitz, MBBCh, MSc
Professor of Medicine and Alberta Health Services Chair in Cardiac Sciences
Director, Cardiovascular Research
Co-Director, Canadian VIGOUR Centre
University of Alberta
Cardiologist, Mazankowski Alberta Heart Institute
Topic: SODIUM-HF: Should Our Patients Consume Less Dietary Sodium?
Date: Friday, April 15, 2022, 1:00-2:00 pm ET
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Grand Rounds April 22: Development of a Novel Research Collaboration with the Retail Industry (Dylan L. Steen, MD, MS; Sarah C. Couch, PhD, RDN)
2022-04-22 13:00 - 14:00
Speaker:
Dylan L. Steen, MD, MS
Adjunct Associate Professor, University of Cincinnati College of Medicine
Director, Clinical Trials and Population Health Research, UC Heart, Lung, and Vascular Institute
CEO, High Enroll LLC (research participant recruitment company)
Sarah C. Couch, PhD, RDN
Professor, Department of Rehabilitation, Exercise and Nutrition Sciences
University of Cincinnati College of Allied Health Sciences
Topic: Development of a Novel Research Collaboration with the Retail Industry
Date: Friday, April 22, 2022, 1:00-2:00 p.m. ET
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Grand Rounds April 29: BP Track: National Surveillance for Blood Pressure Control and Related Process Metrics Using PCORnet (Mark J. Pletcher, MD, MPH; Rhonda Cooper-DeHoff, PharmD, MS; Alanna M. Chamberlain, PhD, MPH)
2022-04-29 13:00 - 14:00 | https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6
Speakers:
Mark J. Pletcher, MD, MPH
Professor of Epidemiology and Biostatistics and Medicine
University of California, San Francisco
Rhonda Cooper-DeHoff, PharmD, MS, FAHA, FACC, FCCP
Association Professor and Research Foundation Professor
University of Florida College of Pharmacy
Alanna M. Chamberlain, PhD, MPH
Associate Professor of Epidemiology
Mayo Clinic
Topic: BP Track: National Surveillance for Blood Pressure Control and Related Process Metrics Using PCORnet
Date: Friday, April 29, 2022, 1:00-2:00 p.m. ET
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Grand Rounds May 6: N-of-1 Randomized Trials: CRAVE and I-STOP-AFib as Examples (Gregory Marcus, MD, MAS)
2022-05-06 13:00 - 14:00
Speaker:
Gregory Marcus, MD, MAS
Professor of Medicine
University of California, San Francisco

Topic: N-of-1 Randomized Trials: CRAVE and I-STOP-AFib as Examples
Date: Friday, May 6, 2022, 1:00-2:00 p.m. ET
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Grand Rounds May 13: Ethics and Collateral Findings in Pragmatic Clinical Trials: Implications of a Multi-Method Exploration (Jeremy Sugarman, MD, MPH, MA; Stephanie Morain, PhD, MPH; Juli Bollinger, MS; Kevin P. Weinfurt, PhD)
2022-05-13 13:00 - 14:00
Speakers:
Jeremy Sugarman, MD, MPH, MA
Deputy Director for Medicine
Harvey M. Meyerhoff Professor of Bioethics and Medicine
Berman Institute of Bioethics
Johns Hopkins University
Stephanie Morain, PhD, MPH
Assistant Professor
Berman Institute of Bioethics
Johns Hopkins University
Juli Bollinger, MS
Research Scientist
Berman Institute of Bioethics
Johns Hopkins University
Kevin P. Weinfurt, PhD
Professor and Vice Chair of Research
Department of Population Health Sciences
Duke University School of Medicine

Topic: Ethics and Collateral Findings in Pragmatic Clinical Trials: Implications of a Multi-Method Exploration
Date: Friday, May 13, 2022, 1:00-2:00 p.m. ET
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Grand Rounds May 20: Long-COVID Studies Within the RECOVER Platform (Upinder Singh, MD)
2022-05-20 13:00 - 14:00 | https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6
Speakers:
Upinder Singh, MD
Professor and Division Chief
Division of Infectious Diseases and Geographic Medicine
Stanford University School of Medicine

Topic:
Long-COVID Studies Within the RECOVER Platform
Date: Friday, May 20, 2022, 1:00-2:00 p.m. ET
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Grand Rounds June 3: Results of the MedSafer Study: Electronic Decision Support for Deprescribing in Hospitalized Older Adults (Emily McDonald MDCM, MSc, FRCPC)
2022-06-03 13:00 - 14:00
Speaker:
Emily G. McDonald MDCM, MSc, FRCPC
Scientific Director; Canadian Deprescribing Network
Associate Professor of Medicine; McGill University

Topic: Results of the MedSafer Study: Electronic Decision Support for Deprescribing in Hospitalized Older Adults
Date: Friday, June 3, 2022, 1:00-2:00 p.m. ET
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Grand Rounds June 10: Do We Really Need So Many Heart Failure Clinicians? (Tariq Ahmad, MD, MPH)
2022-06-10 13:00 - 14:00
Speaker:
Tariq Ahmad, MD, MPH
Director, Cardiac Transplant and MCS
Chief, Heart Failure Program
Yale School of Medicine, Yale New Haven Health

Topic: Do We Really Need So Many Heart Failure Clinicians?
Date: Friday, June 10, 2022, 1:00-2:00 p.m. ET
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NIH Pragmatic Trials Collaboratory 2022 Annual Workshop Critical Questions for Pragmatic Clinical Trialists: Insights From the NIH Pragmatic Trials Collaboratory’s First Decade
2022-06-15 13:00 - 17:00
The NIH Pragmatic Trials Collaboratory will hold a virtual workshop June 15-16, 2022, to explore questions critical to designing and implementing pragmatic clinical trials conducted within healthcare systems. This workshop is an opportunity to glean the most salient lessons learned from an experienced group of the pragmatic trial investigators who will openly share the challenges they have encountered, solutions they have developed, and thoughts for the future.
The workshop, Critical Questions for Pragmatic Clinical Trialists: Insights From the NIH Pragmatic Trials Collaboratory’s First Decade, will take place from 1:00-5:00 p.m. ET each day, kicking off with a keynote presentation by Shannon N. Zenk, PhD, MPH, RN, FAAN, Director, National Institute of Nursing Research, National Institutes of Health, DHHS. All sessions are free and open to the public.
Register today.
See the full schedule.

NIH Pragmatic Trials Collaboratory 2022 Annual Workshop Critical Questions for Pragmatic Clinical Trialists: Insights From the NIH Pragmatic Trials Collaboratory’s First Decade
2022-06-16 13:00 - 17:00
The NIH Pragmatic Trials Collaboratory will hold a virtual workshop June 15-16, 2022, to explore questions critical to designing and implementing pragmatic clinical trials conducted within healthcare systems. This workshop is an opportunity to glean the most salient lessons learned from an experienced group of the pragmatic trial investigators who will openly share the challenges they have encountered, solutions they have developed, and thoughts for the future.
The workshop will include 4 moderated webinar discussions with panels of experts that will focus on changes and current best practices regarding the use of electronic health records for pragmatic research, considerations for pragmatic trial study design, how to optimize a 1-year planning phase for a pragmatic trial, and tips for implementing interventions in complex health systems.
All sessions are free and open to the public.
Register today.
See the full schedule.

Grand Rounds June 17: PREPARE: A Successful, Primarily Remote Pragmatic Trial in a Black and Latinx Population With Asthma: Challenges and Successes (Elliot Israel, MD)
2022-06-17 13:00 - 14:00
Speaker:
Elliot Israel, M.D.
Professor of Medicine
Harvard Medical School
Gloria M. and Anthony C. Simboli Distinguished Chair in Asthma Research
Director of Clinical Research
Pulmonary and Critical Care Division
Allergy and Immunology
Brigham & Women’s Hospital

Topic: PREPARE: A Successful, Primarily Remote Pragmatic Trial in a Black and Latinx Population With Asthma: Challenges and Successes
Date: Friday, June 17, 2022, 1:00-2:00 p.m. ET
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Meeting Number: 2622 682 0537
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Grand Rounds June 24: FDA Draft Guidance on Real-World Evidence (John Concato, MD, MS, MPH)
2022-06-24 13:00 - 14:00
Speaker:
John Concato, MD, MS, MPH
Associate Director for Real-World Evidence Analytics
Office of Medical Policy (OMP)
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration (FDA)
Topic: FDA Draft Guidance on Real-World Evidence
Date: Friday, June 24, 2022, 1:00-2:00 pm ET
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Meeting Number: 2622 682 0537
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Grand Rounds July 8: Results From the COVID-OUT Trial, a Phase-3 Trial of Outpatient Treatment for COVID-19 Using Metformin, Ivermectin, and Fluvoxamine (Carolyn Bramante, MD, MPH; Thomas Murray, PhD; Jaren Huling, PhD)
2022-07-08 13:00 - 14:00
Speakers:
Carolyn Bramante, MD, MPH
Assistant Professor, General Internal Medicine and Pediatrics
Core Faculty, Center for Pediatric Obesity Medicine
Core Faculty, Program for Health Disparities Research
University of Minnesota Medical School
Thomas Murray, PhD
Assistant Professor of Biostatistics
Division of Biostatistics
University of Minnesota School of Public Health
Jared Huling, PhD
Assistant Professor of Biostatistics
Division of Biostatistics
University of Minnesota School of Public Health

Topic: Results From the COVID-OUT Trial, a Phase-3 trial of Outpatient Treatment for Covid-19 Using Metformin, Ivermectin, and Fluvoxamine
Date: Friday, July 8, 2022, 1:00-2:00 p.m. ET

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Grand Rounds July 15: Overview of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Public-Private Partnership and Lessons Learned (Stacey J. Adam, PhD)
2022-07-15 13:00 - 14:00
Speaker:
Stacey J. Adam, PhD
Associate Vice President, Research Partnerships
Foundation for the NIH

Topic: Overview of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Public-Private Partnership and Lessons Learned
Date: Friday, July 15, 2022, 1:00-2:00 p.m. ET

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Grand Rounds July 22: ACTIV-6: One Year Later and Trial Results for Ivermectin-400 and Inhaled Fluticasone (Susanna Naggie, MD, MHS)
2022-07-22 13:00 - 14:00
Speaker:
Susanna Naggie, MD, MHS
Professor of Medicine
Vice Dean for Clinical Research
Duke University School of Medicine
Infectious Diseases Research
Duke Clinical Research Institute

Topic: ACTIV-6: 1-year Later and Trial Results for Ivermectin-400 and Inhaled Fluticasone
Date: Friday, July 22, 2022, 1:00-2:00 p.m. ET

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Grand Rounds July 29: Effect of Early Treatment With Single-Dose Pegylated Interferon Lambda Among Patients With COVID-19: Results From the TOGETHER Trial (Edward Mills, PhD, FRCP; Jeffrey S. Glenn, MD, PhD)
2022-07-29 13:00 - 14:00
Speakers:
Edward Mills, PhD, FRCP
Professor
Department of Health Research Methods, Evidence & Impact
McMaster University, Canada
Jeffrey S. Glenn, MD, PhD
Joseph D. Grant Professor and Professor of Microbiology and Immunology
Stanford University
Topic: Effect of Early Treatment With Single-Dose Pegylated Interferon Lambda Among Patients With COVID-19: Results From the TOGETHER Trial
Date: Friday, July 29, 2022, 1:00-2:00 p.m. ET
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Grand Rounds August 5: Economic Evaluation of Platform Trial Designs (Jay JH Park, PhD, MSc)
2022-08-05 13:00 - 14:00
Speaker:
Jay JH Park, PhD, MSc
Assistant Professor
Department of Health Research Methods, Evidence and Impact
Faculty of Health Sciences
McMaster University
Topic: Economic Evaluation of Platform Trial Designs
Date: Friday, August 5, 2022, 1:00-2:00 p.m. ET

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Grand Rounds August 12: Equitably Including Diverse Participants in Pragmatic Clinical Trials (Consuelo H. Wilkins, MD, MSCI)
2022-08-12 13:00 - 14:00
Speaker:
Consuelo H. Wilkins, MD, MSCI
Senior Vice President and Senior Associate Dean
for Health Equity and Inclusive Excellence
Professor of Medicine
Vanderbilt University Medical Center

Topic: Equitably Including Diverse Participants in Pragmatic Clinical Trials
Date: Friday, August 12, 2022, 1:00-2:00 p.m. ET

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Grand Rounds August 19: Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change (Gerald Bloomfield, MD, MPH; Michelle Kelsey, MD)
2022-08-19 13:00 - 14:00
Speaker:
Gerald Bloomfield, MD, MPH
Associate Professor with Tenure, Medicine
Associate Professor, Global Health
Duke University
Michelle Kelsey, MD
Assistant Professor of Medicine
Duke University School of Medicine

Topic: Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change
Date: Friday, August 19, 2022, 1:00-2:00 p.m. ET

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Grand Rounds August 26: The Diuretic Comparison Project: A Large Pragmatic Clinical Trial (Areef Ishani, MD, MS)
2022-08-26 13:00 - 14:00
Speaker:
Areef Ishani, MD MS
Director, Primary Care and Specialty Medicine Service Line
Minneapolis VA Health Care System
Professor of Medicine
University of Minnesota
Topic: The Diuretic Comparison Project: A Large Pragmatic Clinical Trial
Date: Friday, August 26, 2022, 1:00-2:00 p.m. ET

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Grand Rounds Ethics and Regulatory Series September 9: Building an Academic Learning Health System: Why Is It So Hard? (Steven Joffe, MD, MPH)
2022-09-09 13:00 - 14:00
Speaker:
Steven Joffe, MD, MPH
Art and Ilene Penn Professor and Chair
Department of Medical Ethics & Health Policy
University of Pennsylvania Perelman School of Medicine
Topic: Keynote: Building an Academic Learning Health System: Why Is It So Hard?
Date: Friday, September 9, 2022, 1:00-2:00 p.m. ET

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Grand Rounds September 16: Using Nationwide Registries to Conduct Pragmatic Randomized Trials: The DANFLU Program (Tor Biering-Sørensen, MD, PhD, MPH)
2022-09-16 13:00 - 14:00
Speaker:
Tor Biering-Sørensen, MD, PhD, MPH
Professor in Translational Cardiology and Pragmatic Randomized Trials
Head of Center for Translational Cardiology and Pragmatic Randomized Trials
Department of Biomedical Sciences
Faculty of Health and Medical Sciences
University of Copenhagen
Head of Cardiovascular Non-Invasive Imaging Research Laboratory
Department of Cardiology
Copenhagen University Hospital – Herlev and Gentofte
Topic: Using Nationwide Registries to Conduct Pragmatic Randomized Trials: The DANFLU Program
Date: Friday, September 16, 2022, 1:00-2:00 p.m. ET

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Grand Rounds September 23: Effect Of An Intensive Nurse Home Visiting Program On Adverse Birth Outcomes In A Medicaid-Eligible Population (Margaret McConnell, PhD)
2022-09-23 13:00 - 14:00
Speaker:
Margaret McConnell, PhD
Associate Professor
Harvard T.H. Chan School of Public Health
Topic: Effect Of An Intensive Nurse Home Visiting Program On Adverse Birth Outcomes In A Medicaid-Eligible Population
Date: Friday, September 23, 2022, 1:00-2:00 p.m. ET

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Grand Rounds September 30: CTTI’s Digital Health Trials Hub: Multi-Stakeholder Resources to Conduct Effective Digital Health Trials (Marianne Chase; Jörg Goldhahn, MD)
2022-09-30 13:00 - 14:00
Speaker:
Marianne Chase
Senior Director Clinical Trial Operations
Neurological Clinical Research Institute
Massachusetts General Hospital
Jörg Goldhahn, MD
Medical Director
Director of Institute for Translational Medicine
ETH Zurich
Topic: CTTI’s Digital Health Trials Hub: Multi-Stakeholder Resources to Conduct Effective Digital Health Trials
Date: Friday, September 30, 2022, 1:00-2:00 p.m. ET

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Grand Rounds October 7: Impact Of Handovers Of Anesthesia Care On Morbidity And Mortality (Melanie Meersch-Dini, MD)
2022-10-07 13:00 - 14:00
Speaker:
Melanie Meersch-Dini, MD
Professor
Department of Anesthesiology, Intensive Care and Pain Medicine
University Hospital Münster, Germany
Topic: Impact Of Handovers Of Anesthesia Care On Morbidity And Mortality
Date: Friday, October 7, 2022, 1:00-2:00 p.m. ET

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Grand Rounds Ethics and Regulatory Series October 14: Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials (Joseph Ali, JD; Leslie J. Crofford, MD; Tanya Matthews, PhD)
2022-10-14 13:00 - 14:00
Speaker:
Joseph Ali, JD
Assistant Professor, Dept. of International Health
Johns Hopkins Bloomberg School of Public Health
Core Faculty & Associate Director for Global Programs
Johns Hopkins Berman Institute of Bioethics
Tanya Matthews, PhD
HRPP Director
Kaiser Permanente Washington
Leslie J. Crofford, MD
Wilson Family Chair in Medicine
Professor of Medicine and Pathology, Microbiology & Immunology
Chief, Division of Rheumatology
Vanderbilt University Medical Center
Topic: Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials
Date: Friday, October 14, 2022, 1:00-2:00 p.m. ET

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Grand Rounds October 21: Disinformation, Cyberthreat, and Choice: Protecting Patients and Clinical Research From the Digital Triple Threat (Eric Perakslis, PhD; Andrea Downing)
2022-10-21 13:00 - 14:00
Speaker:
Eric Perakslis, PhD
Chief Science & Digital Officer
Duke Clinical Research Institute
Professor, Department of Population Health Sciences
Chief Research Technology Strategist
Duke University School of Medicine
Andrea Downing
ePatient and Security Researcher
Co-Founder – The Light Collective
Topic: Disinformation, Cyberthreat, and Choice: Protecting Patients and Clinical Research From the Digital Triple Threat
Date: Friday, October 21, 2022, 1:00-2:00 p.m. ET

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