I-SPY 2.2 is working. Why aren’t others replicating the design?

The I-SPY clinical trials are creating a roadmap for a new clinical research vision that cuts inefficiencies, puts patients first, and defines a viable pathway for precision-based drug development. The question now is whether others will replicate the approach outside of breast cancer.

The latest version in the series of trials, I-SPY 2.2, builds on the earlier adaptive platform design for neoadjuvant breast cancer therapies by adding precision medicine to the protocol. It also takes the underlying patient-centricity theme several steps forward through frequent monitoring, early trial exit points, and a treatment block design that minimizes toxicity and exposure to ineffective therapies...