Article

Speeding up the Evaluation of New Agents in Cancer

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)
CancerSpectrum Knowledge Environment (Impact Factor: 15.16). 10/2008; 100(17):1204-14. DOI: 10.1093/jnci/djn267
Source: PubMed

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.

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