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Multi-Arm Clinical Trials of New Agents: Some Design Considerations

Authors' Affiliations:¹ Biometric Research Branch and Clinical Investigations Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland and ² Eastern Cooperative Oncology Group, Harvard School of Public Health, Boston, Massachusetts

Requests for reprints: Boris Freidlin, Biometric Research Branch, EPN-8122, National Cancer Institute, Bethesda, MD 20892. Phone: 301-402-0640; Fax: 301-402-0560; E-mail: freidlinb{at}ctep.nci.nih.gov.

Abstract

A major challenge in the development of anticancer therapies is the considerable time and resources needed for conducting randomized clinical trials (RCT). There is a need for more efficient RCT designs that accelerate development, minimize costs, and make trials more appealing to patients. We review the statistical and logistical characteristics of multi-arm designs that compare several experimental treatments to a common control arm. In particular, we present a rationale for not requiring multiplicity adjustment in multi-arm trials that are designed for logistical efficiency. Relative to conducting separate RCTs for each experimental agent, this multi-arm design is shown to require a lower total sample size than multiple two-arm trials.