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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 BIOS


The 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

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

Click here for Continuing Medical Education Information