Speeding up the evaluation of new agents in cancer

Swart, Ann Marie, Parmar, Mahesh K B, Barthel, Friederike M-S, Sydes, Matthew, Langley, Ruth, Kaplan, Rick, Eisenhauer, Elizabeth, Brady, Mark, James, Nicholas, Bookman, Michael A, Qian, Wendi and Royston, Patrick (2008) Speeding up the evaluation of new agents in cancer. Journal of the National Cancer Institute, 100 (17). pp. 1204-1214. ISSN 1460-2105

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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.

Item Type: Article
Uncontrolled Keywords: united states,randomized controlled trials as topic,disease-free survival,ovarian neoplasms,clinical trials, phase ii as topic,antineoplastic agents,clinical trials, phase iii as topic,humans,clinical trials as topic,research design,antibodies, monoclonal,neoplasms,united states food and drug administration,drug approval,treatment outcome,organoplatinum compounds,sample size,antibodies, monoclonal, humanized,time factors,prostatic neoplasms,female,male,survival analysis
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
Depositing User: Pure Connector
Date Deposited: 01 Oct 2013 00:58
Last Modified: 21 Apr 2020 21:57
URI: https://ueaeprints.uea.ac.uk/id/eprint/43506
DOI: 10.1093/jnci/djn267

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