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Parmar MK , Barthel FM , Sydes M , Langley R , Kaplan R , Eisenhauer E , Brady M , James N , Bookman MA , Swart AM , Qian W , Royston P
Speeding up the evaluation of new agents in cancer
Journal of the National Cancer Institute. 2008 Sep 3;100(17) :1204-14
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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.
Parmar, Mahesh K B Barthel, Friederike M-S Sydes, Matthew Langley, Ruth Kaplan, Rick Eisenhauer, Elizabeth Brady, Mark James, Nicholas Bookman, Michael A Swart, Ann-Marie Qian, Wendi Royston, Patrick Research Support, Non-U.S. Gov't United States Journal of the National Cancer Institute J Natl Cancer Inst. 2008 Sep 3;100(17):1204-14. Epub 2008 Aug 26.