2 - Adaptive Platform Trials for Infectious Diseases

Wednesday, October 19, 2022

1:30 PM – 3:15 PM US ET

Location: 147 AB

Watch the live stream on the conference website.

All relevant financial disclosures have been mitigated.

Moderator(s)

Lindsey Baden, MD

Attending Physician
Infectious Diseases
Brigham and Women's Hospital
Boston, Massachusetts, United States

Disclosure(s): Moderna, Inc.: Grant/Research Support (); NIAID: Grant/Research Support ()
Peter Marks, MD, PhD

Director, Center of Biologics Evaluation and Research
Food & Drug Administration
Silver Spring, MD, United States

Disclosure(s): No financial relationships to disclose
TH

Thomas Holland, MD

I do not have any relevant financial / non-financial relationships with any proprietary interests.

Faculty(s)

Anna McGlothlin, PhD

Director and Senior Statistical Scientist
Berry Consultants
Austin, Texas, United States

Disclosure(s): Multiple: Advisor/Consultant (Ongoing)

Slides
Roger Lewis, MD, PhD (he/him/his)

Senior Medical Scientist
Berry Consultants, LLC, CA, United States

Disclosure(s): No financial relationships to disclose
Jens Lundgren, MD DMSc

Professor
PERSIMUNE/CHIP, Department of Infectious Diseases
Rigshospitalet, University of Copenhagen
Copenhagen, Hovedstaden, Denmark

Disclosure(s): No financial relationships to disclose

Slides
Steven Tong, MBBS, Hon FRACP, PhD

Clinician scientist
Doherty Institute, University of Melbourne

Disclosure(s): Roivant Sciences: Advisor/Consultant (Ongoing)

Slides
Susanna Naggie, MD/MHS

Professor of Medicine with Tenure/Vice Dean of Clinical Research
DCRI/ School of Medicine
Durham, North Carolina, United States

Disclosure(s): AbbVie: Grant/Research Support (); BMS/PRA: Event adjudication (); Gilead Sciences: Grant/Research Support (); Pardes Biosciences: Advisor/Consultant (); Personal Health Insights, Inc: Data Safety Monitoring Board Member (); Silverback Therapeutics: Advisor/Consultant (); Vir Biotechnology: Advisor/Consultant (), Stocks/Bonds ()

Disclosure(s):

Lindsey R. Baden, MD: Moderna, Inc.: Grant/Research Support (); NIAID: Grant/Research Support ()

Peter Marks, MD, PhD: No financial relationships to disclose

Anna McGlothin, PhD: Multiple: Advisor/Consultant (Ongoing)

Roger J. Lewis, MD, PhD: No financial relationships to disclose

Jens Lundgren, MD DMSc: No financial relationships to disclose

Steven Tong, MBBS, Hon FRACP, PhD: Roivant Sciences: Advisor/Consultant (Ongoing)

Susanna Naggie, MD/MHS: AbbVie: Grant/Research Support (); BMS/PRA: Event adjudication (); Gilead Sciences: Grant/Research Support (); Pardes Biosciences: Advisor/Consultant (); Personal Health Insights, Inc: Data Safety Monitoring Board Member (); Silverback Therapeutics: Advisor/Consultant (); Vir Biotechnology: Advisor/Consultant (), Stocks/Bonds ()

CME Credits: Maximum of 1.75 hours of AMA PRA Category 1 Credit™
MOC Credits: Maximum of 1.75 hours of MOC Credit
CNE Credits: Maximum of 1.75 hours of ANCC Credit
ACPE Credits: ACPE 1.75 contact hours of pharmacy CE
ACPE Number: JA0007082-0000-22-002-L01-P

Learning Objectives:

At the conclusion of this session, participants will be able to:

evaluate the design, advantages and limitations of adaptive trial platforms in infectious diseases;
analyze current platforms for COVID and S. aureus bacteremia trials;
appraise the results from platform trials

Presentations:

1:30 PM – 1:45 PM US ET

The Basics: What Is An Adaptive Trial, and What Are Potential Strengths and Weaknesses?
Speaker: Anna McGlothlin, PhD – Berry Consultants
1:45 PM – 2:00 PM US ET

How to Read a Bayesian Adaptive Platform Trial Publication
Speaker: Roger J. Lewis, MD, PhD (he/him/his) – Berry Consultants, LLC
2:00 PM – 2:30 PM US ET

Overview of Current Adaptive Platforms and Pragmatic Advice for Those That Might Start One
Speaker: Steven Tong, MBBS, Hon FRACP, PhD – Doherty Institute, University of Melbourne
Speaker: Jens Lundgren, MD DMSc – Rigshospitalet, University of Copenhagen
2:30 PM – 3:15 PM US ET

Moderated Panel Discussion on Adaptive Trials
Panelist: Steven Tong, MBBS, Hon FRACP, PhD – Doherty Institute, University of Melbourne
Panelist: Jens Lundgren, MD DMSc – Rigshospitalet, University of Copenhagen
Panelist: Anna McGlothlin, PhD – Berry Consultants
Panelist: Susanna Naggie, MD/MHS – DCRI/ School of Medicine