Board Of Directors
Two articles published today in the July 7, 2016 issue of the New England Journal of Medicine (NEJM) reinforce the importance of multi-drug standing platform clinical trials, in particular the I-SPY 2 Phase 2 Clinical Trial for Breast Cancer (I-SPY 2), to accelerate identification and development of effective treatments for challenging diseases such as women with primary breast cancer at high risk for early recurrence, including triple negative and HER2-positive breast cancer. In Adaptive Randomization of Veliparib—Carboplatin Treatment in Breast Cancer and Adaptive Randomization Trial of Neratinib in Breast Cancer, the authors provide methodology and statistical evidence clearly indicating the potential for I-SPY 2 to accelerate the process of screening drugs. I-SPY 2 seeks to provide the basis for personalizing treatments with a novel study design. Its goals are to improve the efficiency of clinical trials and to streamline the process of finding genetically targeted treatments for patient subgroups and accelerate the development of these new regimens where they are most urgently needed.