Rethinking Clinical Trials

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 (America/New_York)
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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Grand Rounds October 28: The HERO (Healthcare Worker Exposure Response & Outcomes) Program: An Online Community to Support Observational Studies, Randomized Trials, and Long-Term Safety Surveillance (Emily O'Brien, PhD, FAHA; Russell Rothman, MD, MPP)
2022-10-28 13:00 - 14:00
Speaker:
Emily O’Brien, PhD, FAHA
Associate Professor
Duke Clinical Research Institute
Duke University School of Medicine
Department of Population Health Sciences
Russell Rothman, MD, MPP
Senior Vice President, Population and Public Health
Director, Vanderbilt Institute for Medicine and Public Health
Vanderbilt University Medical Center
Topic: The HERO (Healthcare Worker Exposure Response & Outcomes) Program: An Online Community to Support Observational Studies, Randomized Trials, and Long-Term Safety Surveillance
Date: Friday, October 28, 2022, 1:00-2:00 p.m. ET

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Toward Causal Inference in Cluster Randomized Trials: Estimands and Reflection on Current Practice
2022-11-03 15:00
Methods: Minds the Gap Webinar Series
“Toward Causal Inference in Cluster Randomized Trials: Estimands and Reflection on Current Practice”
Fan Li, PhD; Yale School of Public Health
National Institutes of Health, Office of Disease Prevention

Cluster randomized trials (CRTs) involve randomizing groups of individuals to different interventions. While model-based methods are extensively studied for analyzing CRTs, there has been little reflection around the treatment effect estimands at the outset. In the first part of this presentation, we describe two relevant estimands that can be addressed through CRTs and point out that they can differ when the treatment effects vary according to cluster sizes. As a cautionary note, we demonstrate how choices between different analytic approaches can impact the interpretation of results by fundamentally changing the question being asked. In the second part, we revisit the linear mixed model as the most commonly used method for analyzing CRTs. The linear mixed model makes stringent assumptions, including normality, linearity, and typically a compound symmetric correlation structure, all of which may be challenging to verify. However, under certain conditions, we show that the linear mixed model consistently estimates the average causal effect under arbitrary misspecification of its working model. Under equal randomization, its model-based variance estimator, surprisingly, remains consistent under model misspecification, justifying the use of confidence intervals output by standard software. These results hold under both simple and stratified randomization, and serve as an important causal inference justification for linear mixed models. Caveats and extensions of our findings will also be mentioned.
For more information, visit https://prevention.nih.gov/education-training/methods-mind-gap/toward-causal-inference-cluster-randomized-trials-estimands-and-reflection-current-practice.

Grand Rounds November 4, 2022: The CardioNerds Clinical Trials Network: Pairing Equitable Enrollment With Trainee Development (Amit Goyal, MD, MAS)
2022-11-04 13:00 - 14:00
Speaker:
Amit Goyal, MD, MAS
Interventional/Structural Fellow, Cleveland Clinic
Cofounder of CardioNerds
Topic: The CardioNerds Clinical Trials Network: Pairing Equitable Enrollment With Trainee Development
Date: Friday, November 4, 2022, 1:00-2:00 p.m. ET

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Grand Rounds Ethics and Regulatory Series November 11: Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst a Changing Policy Landscape (Stephanie Morain, PhD, MPH; Kayte Spector-Bagdady, JD, MBioethics)
2022-11-11 13:00 - 14:00
Speaker:
Stephanie Morain, PhD, MPH
Assistant Professor
Berman Institute of Bioethics & Johns Hopkins Bloomberg School of Public Health
Kayte Spector-Bagdady, JD, MBioethics
Associate Director, Center for Bioethics & Social Sciences in Medicine
Assistant Professor of Obstetrics & Gynecology
University of Michigan Medical School
Topic: Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst a Changing Policy Landscape
Date: Friday, November 11, 2022, 1:00-2:00 p.m. ET

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Grand Rounds November 18, 2022: The FIRST-ABC Pragmatic Trials of Non-Invasive Respiratory Support In Children (Padmanabhan Ramnarayan, MBBS, MD, FRCPCH, FFICM)
2022-11-18 13:00 - 14:00
Speaker:
Padmanabhan Ramnarayan (Ram), MBBS, MD, FRCPCH, FFICM
Reader in Pediatric Critical Care
Imperial College London
Topic: The FIRST-ABC Pragmatic Trials of Non-Invasive Respiratory Support In Children
Date: Friday, November 18, 2022, 1:00-2:00 p.m. ET

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Grand Rounds December 2, 2022: A Randomized Controlled Trial of a Mobile Health Intervention in Heart Failure and Diabetes: Lessons Learned (G. Michael Felker, MD, MHS)
2022-12-02 13:00 - 14:00
Speaker:
G. Michael Felker, MD, MHS
Professor of Medicine
Director, Cardiovascular and Metabolism Research, DCRI
Topic: A Randomized Controlled Trial of a Mobile Health Intervention in Heart Failure and Diabetes: Lessons Learned
Date: Friday, December 2, 2022, 1:00-2:00 p.m. ET

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Grand Rounds Ethics and Regulatory Series December 9: The Stepped-Wedge Cluster Randomized Trial: Friend or Foe? (Monica Taljaard, PhD; David Magnus, PhD)
2022-12-09 13:00 - 14:00
Speaker:
Monica Taljaard, PhD
Senior Scientist, Clinical Epidemiology Program
Ottawa Hospital Research Institute
Full Professor, Epidemiology and Community Medicine
University of Ottawa
David Magnus, PhD
Thomas A. Raffin Professor of Medicine and Biomedical Ethics and Professor of Pediatrics, Medicine, and by courtesy of Bioengineering
Director, Stanford Center for Biomedical Ethics
Associate Dean for Research
Topic: The Stepped-Wedge Cluster Randomized Trial: Friend or Foe?
Date: Friday, December 9, 2022, 1:00-2:00 p.m. ET

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Grand Rounds December 16, 2022: The Use of EHR-Agnostic Clinical Decision Support to Prevent Thromboembolism in Hospitalized Medically Ill Patients (Alex C. Spyropoulos, MD, FACP, FCCP, FRCPC; Jeffrey Solomon, BFA)
2022-12-16 13:00 - 14:00
Speaker:
Alex C. Spyropoulos, MD, FACP, FCCP, FRCPC
Professor of Medicine – The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
Professor – Institute of Health System Science – The Feinstein Institutes for Medical Research
System Director – Anticoagulation and Clinical Thrombosis Services
Northwell Health at Lenox Hill Hospital
Jeffrey Solomon, BFA
Senior Director, Usability Lab
Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY
Topic: The Use of EHR-Agnostic Clinical Decision Support to Prevent Thromboembolism in Hospitalized Medically Ill Patients
Date: Friday, December 16, 2022, 1:00-2:00 p.m. ET

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Grand Rounds January 6, 2023: Outpatient Treatment of COVID-19 With Metformin, Ivermectin, or Fluvoxamine: 10-Month Follow-up and Effects on Developing Long COVID (Carolyn Bramante, MD, MPH; Thomas Murray, PhD)
2023-01-06 13:00 - 14:00
Speaker:
Carolyn Bramante, MD, MPH
Division of General Internal Medicine
Departments of Internal Medicine and Pediatrics
Core faculty in the Program in Health Disparities Research and the Center for Pediatric Obesity Medicine
University of Minnesota Medical School
Thomas Murray, PhD
Division of Biostatistics
Coordinating Centers for Biometric Research
University of Minnesota School of Public Health
Topic: Outpatient Treatment of COVID-19 With Metformin, Ivermectin, or Fluvoxamine: 10-Month Follow-up and Effects on Developing Long COVID
Date: Friday, January 6, 2023, 1:00-2:00 pm ET
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Grand Rounds Ethics and Regulatory Series January 13: Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials (Emily A. Largent, JD, PhD, RN)
2023-01-13 13:00 - 14:00
Speaker:
Emily A. Largent, JD, PhD, RN
Emanuel & Robert Hart Assistant Professor of Medical Ethics and Health Policy
Department of Medical Ethics and Health Policy
University of Pennsylvania Perelman School of Medicine
Topic: Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials
Date: Friday, January 13, 2023, 1:00-2:00 p.m. ET

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Grand Rounds January 20, 2023: Collaborative Pragmatic Trials in Action: EVOLVE-MI (Mikhail Kosiborod, MD)
2023-01-20 13:00 - 14:00
Speaker:
Mikhail Kosiborod, MD
Vice President of Research
Saint Luke’s Health System
Professor of Medicine
University of Missouri-Kansas City
Topic: Collaborative Pragmatic Trials in Action: EVOLVE-MI
Date: Friday, January 20, 2023, 1:00-2:00 pm ET
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Grand Rounds January 27, 2023: The PREPARE II Trial: Embedding a Pragmatic Trial Into Clinical Care During an Emergency Procedure (Derek W. Russell, MD; Matthew W. Semler, MD, MSc)
2023-01-27 13:00 - 14:00
Speaker:
Derek W. Russell, MD
Assistant Professor, Department of Medicine
Co-Director, Program in Medical ICU Research
Division of Pulmonary, Allergy & Critical Care Medicine
Assistant Medical Director, Birmingham Veterans Affairs Medical Center MICU
University of Alabama at Birmingham Heersink School of Medicine
Matthew W. Semler, MD, MSc
Assistant Professor of Medicine and Biomedical Informatics
Medical Director, Center for Learning Healthcare, Vanderbilt Institute for Clinical and Translational Research
Vanderbilt University Medical Center
Topic: The PREPARE II Trial: Embedding a Pragmatic Trial Into Clinical Care During an Emergency Procedure
Date: Friday, January 27, 2023, 1:00-2:00 p.m. ET

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Grand Rounds February 3, 2023: Pragmatic Trials For Children With Congenital Heart Disease: Insights From The NITRIC Trial (Luregn Schlapbach, PhD, FCICM)
2023-02-03 13:00 - 14:00
Speaker:
Prof Luregn Schlapbach, PhD, FCICM
Head, Department of Intensive Care and Neonatology
University Children`s Hospital, Zurich
Zurich, Switzerland
The University of Queensland
Brisbane, Australia
Topic: Pragmatic Trials For Children With Congenital Heart Disease: Insights From The NITRIC Trial
Date: Friday, February 3, 2023, 1:00-2:00 p.m. ET
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Grand Rounds Ethics and Regulatory Series February 10: Informing and Consenting: What Are the Goals? (P. Pearl O'Rourke, MD; David S. Wendler, PhD, MA; Miguel Vazquez, MD; P. Michael Ho, MD, PhD)
2023-02-10 13:00 - 14:00
Speaker:
P. Pearl O’Rourke, MD (retired)
Harvard Medical School
David S. Wendler, PhD, MA
Senior Researcher
Head, Section on Research Ethics
Department of Bioethics
NIH Clinical Center
Miguel Vazquez, MD
Professor of Internal Medicine
UT Southwestern Medical Center
P. Michael Ho, MD, PhD
Professor of Medicine
University of Colorado School of Medicine
Topic: Informing and Consenting: What Are the Goals?
Date: Friday, February 10, 2023, 1:00-2:00 p.m. ET
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Grand Rounds February 17, 2023: The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials (Michael Gibson, MS, MD)
2023-02-17 13:00 - 14:00
Speaker:
Michael Gibson, M.S., M.D.
Professor of Medicine Harvard
Interventional Cardiologist BI Lahey
CEO & President of the non-Profit Baim Institute for Clinical Research & PERFUSE Study Group
Topic: The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials
Date: Friday, February 17, 2023, 1:00-2:00 p.m. ET
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Grand Rounds February 24, 2023: S2302 Pragmatica-Lung: New Directions for Decreasing Burden and Increasing Inclusion in NCTN Clinical Trials (Konstantin Dragnev, MD; Karen Reckamp, MD, MS)
2023-02-24 13:00 - 14:00
Speaker:
Konstantin Dragnev, MD
Professor of Medicine, Hematology/Oncology
Irene Heinz Given Professor in Pharmacology
Associate Director for Clinical Research
Principal Investigator – Dartmouth Lead Academic Participating Site for NCTN
Dartmouth Cancer Center
Dartmouth Health
Karen Reckamp, MD, MS
Director, Division of Medical Oncology
Associate Director, Clinical Research
Clinical Professor, Department of Medicine
Topic: S2302 Pragmatica-Lung: New Directions for Decreasing Burden and Increasing Inclusion in NCTN Clinical Trials
Date: Friday, February 24, 2023, 1:00-2:00 p.m. ET
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