Spies plot revolution

I-SPY 2 joins FDA, NIH, pharma and academics to speed breast cancer trials

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.

As a result, only a handful of drugs have been approved in any indication for subpopulations identified by a diagnostic test and adaptive trial methods haven't been widely adopted, even as drug development has arguably slowed down over the last dozen years.

I-SPY 2 (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And MoLecular Analysis 2) is intended to create a paradigm shift in clinical development by simultaneously testing multiple drug candidates in a Phase II setting, integrating biomarkers of response, and rapidly identifying biomarker/drug candidates that would be highly likely to succeed in Phase III.

Because of its scale, and the active involvement of FDA, the National Cancer Institute and patient advocates, I-SPY 2 could overcome barriers to using innovative trials designs that have been difficult or impossible for individual companies to surmount.

I-SPY 2 is necessary and important because drug development in general, and cancer research in specific, hasn't kept pace with advances in biology, clinical trial design and bioinformatics, according to Janet Woodcock, director of FDA's Center for Drug Evaluation and

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