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Decade in review—clinical trials

Shifting paradigms in cancer clinical trial design

Over the past decade, there have been profound shifts in clinical trial design. Phase II randomized studies, phase II/III and other adaptive designs, early surrogate end points, and prospective biomarker-based patient selection have all increased in popularity. We discuss these shifts in clinical trial designs that have increased efficiency in identifying which patients will benefit from specific treatments.

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Correspondence to Daniel J. Sargent.

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Sargent, D., Korn, E. Shifting paradigms in cancer clinical trial design. Nat Rev Clin Oncol 11, 625–626 (2014). https://doi.org/10.1038/nrclinonc.2014.167

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