Published in

Oxford University Press, Journal of the National Cancer Institute, 17(100), p. 1204-1214, 2008

DOI: 10.1093/jnci/djn267

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Speeding up the Evaluation of New Agents in Cancer

This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

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Abstract

Despite both the increase in basic biologic knowledge and the fact that many new agents have reached various stages of development during the last 10 years, the number of new treatments that have been approved for patients has not increased as expected. We propose the multi-arm, multi-stage trial design as a way to evaluate treatments faster and more efficiently than current standard trial designs. By using intermediate outcomes and testing a number of new agents (and combinations) simultaneously, the new design requires fewer patients. Three trials using this methodology are presented.