FDA-AACR Workshop: How Much is Enough? Trial Designs for Treatment Regimens with Multiple Phases
FDA-AACR Workshop: How Much is Enough? Trial Designs for Treatment Regimens with Multiple Phases
Date: May 9, 2024 | 9:00 a.m. – 4:00 p.m.
Location: The Bethesda Marriott, 5151 Pooks Hill Rd, Bethesda, MD 20814
**Slides and videos are available below
agenda SPEAKER BIOSThe U.S. Food and Drug Administration (FDA) Oncology Center of Excellence and the American Association for Cancer Research (AACR) are collaborating on a one-day hybrid public workshop to discuss trial designs for treatment regimens with multiple phases. This builds on a previous FDA-AACR-ASA workshop in 2023 on Overall Survival (OS).
Recently reported results and approved regimens in the perioperative space for breast, lung and other cancers raise questions regarding optimal therapy and the potential for overtreatment. Current evidence may not support the continuation of such trials, which do not isolate the contribution of each phase of treatment to the effect of the overall regimen. Future trial designs, which may need to include multiple treatment arms, should aim to elucidate the impact of each phase of treatment.
The goal is to foster robust scientific discussion to explore approaches that address uncertainty in the interpretation of several high-profile clinical trials which contain regimens that do not isolate the contribution of each treatment phase. Speakers will also explore considerations for the assessment and interpretation of OS in early-stage trials with regimen approaches where long-term OS is a critical variable. The workshop will provide an interdisciplinary forum to discuss the best practices of trial design, analyses, and interpretation of trials with multiple phases of treatment.
WORKSHOP CO-CHAIRS:
Elizabeth Jaffee, MD, FAACR, FCP, Deputy Director, Sidney Kimmel Comprehensive Cancer Center
Harpreet Singh, MD, Director, Division of Oncology 2, U.S. Food and Drug Administration
PROGRAM
Session 1: Current Landscape for Perioperative Trial Designs
Moderator: Erin Larkins, MD, U.S. Food and Drug Administration
Session 2A: Optimizing Perioperative Treatment Regimens
Moderator: Elizabeth Jaffee, MD, Sidney Kimmel Comprehensive Cancer Center
Fireside Chat with FDA/OCE Division Directors
Moderator: Harpreet Singh, MD, U.S. Food and Drug Administration
Session 2B: The Future of Registrational Trials with Multiple Arms
Moderator: Bernardo Haddock Lobo Goulart, MD, U.S. Food and Drug Administration
Session 3: Considerations in Other Therapeutic Areas
Moderator: Mirat Shah, MD, U.S. Food and Drug Administration
Continuing Medical Education Activity AMA PRA Category 1 CreditsTM available
