Spies plot revolution

The I-SPY 2 trial, launched last week, is intended to both speed development of compounds for locally advanced breast cancer and to serve as a model for integrating biomarkers, adaptive trial designs, and bioinformatics to quickly, inexpensively and simultaneously test multiple drug candidates.

For years, companies have wanted to do more trials using adaptive designs, to test investigational cancer compounds in early stage breast and other cancers, and to develop biomarkers to identify likely responders. A set of logistical and regulatory impediments has made studies using any one of these elements uncommon, and has prevented their combination...