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PerspectiveStatistics in Medicine

I-SPY 2 — A Glimpse of the Future of Phase 2 Drug Development?

List of authors.
  • David Harrington, Ph.D.,
  • and Giovanni Parmigiani, Ph.D.

The I-SPY 2 breast cancer trials assess activity of new agents by adaptive randomization, applying criteria for success on a surrogate end point to predict success in confirmatory trials. Innovative designs may speed progress and eliminate waste in drug development.

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Funding and Disclosures

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

Author Affiliations

From the Department of Biostatistics and Computational Biology, Dana–Farber Cancer Institute, and the Department of Biostatistics, Harvard T.H. Chan School of Public Health — both in Boston.

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