In Episode 20 of Berry’s "In the Interim..." Podcast, The Legend of I-SPY 2 - Part A, Dr. Don Berry and Dr. Scott Berry discuss the origins and design of the I-SPY trials. Their conversation explains the inefficiency of traditional adjuvant breast cancer trials and details the shift to the neoadjuvant approach, where tumor response can be observed prior to surgery.
I-SPY 1 served as a proof-of-concept using MRI for probabilistic prediction of pathologic complete response (pCR). I-SPY 2 represents a major advancement in clinical trial science, introducing a multi-arm bandit methodology, integration of biomarker-driven subtypes and signatures, and a structured funding model that transitioned from philanthropy to “pay to play” industry support.