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Journal of the National Cancer Institute Advance Access published online on August 26, 2008
JNCI Journal of the National Cancer Institute, doi:10.1093/jnci/djn267
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© 2008 The Author(s).
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/2.0/uk/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

COMMENTARY

Speeding up the Evaluation of New Agents in Cancer

Mahesh K. B. Parmar, Friederike. M.-S. Barthel, Matthew Sydes, Ruth Langley, Rick Kaplan, Elizabeth Eisenhauer, Mark Brady, Nicholas James, Michael A. Bookman, Ann-Marie Swart, Wendi Qian, Patrick Royston

Affiliations of authors: MRC Clinical Trials Unit, London, UK (MKBP, MS, RL, RK, AMS, WQ, PR); Institute of Psychiatry, King’s College London, London, UK (FMSB); NCIC Clinical Trials Group, Queen's University, Kingston, Ontario, Canada (EE); School of Public Health and Health Professions, University at Buffalo, Buffalo, NY (MB); CR-UK Institute for Cancer Studies, University of Birmingham, Birmingham, UK (NJ); Fox Chase Cancer Center, Philadelphia, PA (MAB)

Correspondence to: Mahesh K. B. Parmar, DPhil, MRC Clinical Trials Unit, 222 Euston Road, London, NW1 2DA, UK (e-mail: mp{at}ctu.mrc.ac.uk).

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.

Manuscript received July 7, 2007; revised June 6, 2008; accepted July 3, 2008.


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