Multi-arm clinical trials of new agents: some design considerations

Clin Cancer Res. 2008 Jul 15;14(14):4368-71. doi: 10.1158/1078-0432.CCR-08-0325.

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.

Publication types

  • Review

MeSH terms

  • Antineoplastic Agents / therapeutic use*
  • Clinical Trials, Phase III as Topic*
  • Humans
  • Neoplasms / drug therapy*
  • Randomized Controlled Trials as Topic*
  • Research Design*

Substances

  • Antineoplastic Agents