101 - Clinical Trials Based on Benefit-Risk: An Open DOOR

Friday, October 18, 2024

8:00 AM – 9:00 AM US PT

Location: 408 B

All relevant financial relationships have been mitigated.

CME Credits: Maximum of 1 hours of AMA PRA Category 1 Credit™
MOC Credits: Maximum of 1 hours of MOC Credit
CNE Credits: Maximum of 1 hours of ANCC Credit
ACPE Credits: ACPE 1 knowledge-based contact hours of pharmacy CE
ACPE Number: JA0007082-9999-24-002-L01-P
PACE Credits: Maximum of 1 of PACE contact hours
CE Broker: Maximum of 1 CE broker credit hours

Moderator(s)

Yohei Doi, MD, PHD (he/him/his)

Professor of Medicine
Division of Infectious Diseases
University of Pittsburgh
Toyoake, Aichi, Japan
Scott Evans, PhD, M.S. (he/him/his)

Professor and Director of the Biostatistics Center
Epidemiology and Biostatistics
Milken Institute School of Public Health
Rockville, MD, United States

Faculty(s)

Jessica Howard-Anderson, MD, MSc (she/her/hers)

Infectious Diseases Physician
Emory University
Atlanta, GA, United States
Toshimitsu Hamasaki, PhD

Professor
The George Washington University
Rockville, MD, United States

Disclosure(s):

Yohei Doi, MD, PHD: AbbVie: Advisor/Consultant (Terminated, October 31, 2023); bioMerieux: Advisor/Consultant (Terminated, December 31, 2022); Entasis Pharmaceuticals: Grant/Research Support (Ongoing); FujiFilm: Advisor/Consultant (Terminated, December 31, 2022); Gilead: Advisor/Consultant (Terminated, November 30, 2023), Honoraria (Terminated, November 30, 2023); GlaxoSmithKline (GSK): Advisor/Consultant (Terminated, March 31, 2023); Meiji Seika Pharma: Advisor/Consultant (Ongoing); Moderna: Advisor/Consultant (Terminated, November 30, 2023); MSD: Advisor/Consultant (Terminated, December 31, 2022), Honoraria (Terminated, December 31, 2022); Pfizer, Inc.: Advisor/Consultant (Terminated, November 30, 2023); Shionogi: Advisor/Consultant (Ongoing), Grant/Research Support (Ongoing), Honoraria (Ongoing)

Scott R. Evans, PhD, M.S.: Abbvie: Advisor/Consultant (); Advantagene: Advisor/Consultant (); Akouos: Advisor/Consultant (); Apellis: Advisor/Consultant (); AstraZenenca: Advisor/Consultant (); BARDA: Advisor/Consultant (); Breast International Group: Advisor/Consultant (); CDC: Grant/Research Support (); Clover: Advisor/Consultant (); DayOneBio: Advisor/Consultant (); Degruyter: Editorial service (); Duke University: Advisor/Consultant (); Eli Lilly: Advisor/Consultant (); FDA: Advisor/Consultant (); Frontier Science Foundation: Board Member (); Genentech: Advisor/Consultant (); GSK: Advisor/Consultant (); Henry Jackson Foundation: Grant/Research Support (); International Drug Development Institute: Advisor/Consultant (); Johson & Johnson: Advisor/Consultant (); Medtronic: Advisor/Consultant (); NIH: Grant/Research Support (); Novartis: Advisor/Consultant (); Pfizer: Advisor/Consultant (); Rakuten: Advisor/Consultant (); Roche: Advisor/Consultant (); Takeda: Advisor/Consultant (); Taylor & Francis: Book royalties (); Teva: Advisor/Consultant (); University of Penn: Advisor/Consultant (); Vir: Advisor/Consultant (); Wake Forest University: Advisor/Consultant (); Washington University: Advisor/Consultant ()

Jessica Howard-Anderson, MD, MSc: No financial relationships to disclose

Toshimitsu Hamasaki, PhD: No financial relationships to disclose

Learning Objectives:

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

recognize advantages and potential pitfalls of door analysis;
describe how door is integrated in registrational trials;
identify available tools that facilitate door analysis;
apply door to their own clinical datasets.

Presentations:

8:00 AM – 8:30 AM US PT

Implementing DOOR in Registrational Antibacterial Trials
Speaker: Jessica Howard-Anderson, MD, MSc (she/her/hers) – Emory University
8:30 AM – 9:00 AM US PT

Unlocking Insights: A DIY Guide to Conducting DOOR Analysis with Your Own Dataset
Speaker: Toshimitsu Hamasaki, PhD – The George Washington University