Online Program

Return to main conference page
Thursday, September 13
Thu, Sep 13, 4:15 PM - 5:30 PM
Thurgood Marshall West
Design and Analysis of Cancer Immunotherapy Trials

Estimand and analysis considerations of phase 3 clinical trials involving CAR-T – A case study in lymphoma (300812)

*Michael Yiyun Zhang, Novartis Oncology 

Marked by the recent approval of the first chimeric antigen receptor T cell (CAR-T) therapies, these autologous therapies provided patients with new options to fight cancer. Unique challenges arises in the design and analysis of randomized studies involving autologous CAR-T therapies. Because the CAR-T treatment strategy involves personalized manufacturing before patients can receive the final product, the scientific objective and its associated estimand must be carefully thought through to allow appropriate interpretation of study results. Different testing procedures and estimation methods will be discussed in a case study of Phase 3 clinical trial.