The design of clinical trials is an ongoing discussion among researchers and one that deserves discourse, especially regarding overall survival. While it seems like a simple metric, providing conclusive data on overall survival is rather complex. 

To discuss overall survival and the factors that can make accuracy challenging, the U.S. Food and Drug Administration, the American Association of Cancer Researchers (AACR) and the American Statistical Association partnered to sponsor a workshop, “Overall Survival in Oncology Clinical Trials,” in July, 2023, and Mikkael Sekeres, M.D., chief of the Division of Hematology at Sylvester and professor of medicine, chaired the workshop’s first session. 

“Determining overall survival — how long somebody lives — is much more difficult than you might guess,” said Dr. Sekeres, “You would think calculating survival wouldn’t be rocket science, but it turns out that it is.” 

What is overall survival? According to the National Cancer Institute, it is the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. Dr. Sekeres has spent years working with the FDA and others to refine clinical studies.