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FDA-AACR-ASA Workshop: Overall Survival in Oncology Clinical Trials

July 18, 2023
8 a.m.-5 p.m. EST
Bethesda Marriott Pooks Hill

North Bethesda, Maryland

Slide presentations and recordings from this event are available below.

event agenda speaker bios read background blog

The American Association for Cancer Research (AACR), American Statistical Association (ASA), and U.S. Food and Drug Administration (FDA) are partnering to host this workshop to discuss the use of overall survival (OS) and other endpoints in oncology clinical trials.

OS is considered a gold standard endpoint for clinical trials because it measures both efficacy and safety of new therapies. It is also a relatively simple and straightforward metric that matters to patients who want to know if a drug will help them live longer. Advancements in cancer care have improved the lives of many patients, however, it is becoming increasingly difficult to measure OS in a timely fashion to support approval of new drugs. This is leading to the growing use of early endpoints like progression-free survival or durable response rates for submissions to the FDA. When early endpoints are used, FDA will often require companies to share OS data when they become available following Accelerated Approval or Traditional Approval. Unfortunately, several factors can pose challenges for monitoring long-term OS, including differences between subpopulations; crossover trial designs; subsequent lines of therapy after a patient leaves a trial; and fluctuations in the magnitude of benefit compared to the control arm over time.


(click titles to view presentation slides)

Welcome and Background – FDA-AACR-ASA Overall Survival Workshop

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Session 1: Trial Design Considerations for Optimal Assessment of Overall Survival

  • Moderator: Ken Anderson, MD, FAACR, Dana-Farber Cancer Institute
  • Session Chair: Mikkael Sekeres, MD, Sylvester Comprehensive Cancer Center, University of Miami

○  Slides ○  Video

Session 2: Overall Survival as a Pre-specified Endpoint

  • Moderator: Lisa Rodriguez, PhD, FDA
  • Session Chair: Ruben Mesa, MD, Wake Forest Baptist Comprehensive Cancer Center

○  Slides ○  Video

Session 3: Post-hoc Analyses of Overall Survival Endpoints

  • Moderator: Jonathon Vallejo, PhD, FDA
  • Session Chair: Steven Snapinn, PhD, Seattle-Quilcene Biostatistics, LLC

○  Slides ○  Video

Session 4: Subgroup Considerations

  • Moderator: Ruixiao Lu, PhD, ASA/Alumis
  • Session Chair: Keith Flaherty, MD, FAACR, Massachusetts General Hospital Cancer Center

○  Slides ○  Video

Session 5: Incorporation of Overall Survival into the benefit-risk assessment

  • Moderator: Nicole Gormley, MD, FDA
  • Session Chair: George Demetri, MD, FAACR, Dana-Farber Cancer Institute

○  Slides ○  Video

Summary and Closing Remarks – FDA-AACR-ASA Overall Survival Workshop

○  Slides ○  Video