Multi-arm clinical trials of new agents: some design considerations.
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.
Freidlin
Boris
B
Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland, USA. freidlinb@ctep.nci.nih.gov
Korn
Edward L
EL
Gray
Robert
R
Martin
Alison
A
D000970:Antineoplastic Agents / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design
D000970:Antineoplastic Agents