Work

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

Year: 2008

Type: article

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.

Source: Clinical Cancer Research

DOI: 10.1158/1078-0432.ccr-08-0325

Authors: Boris Freidlin, Edward L. Korn, Robert Gray, Alison Martin

Institutions: National Institutes of Health, National Cancer Institute, Harvard University

Language: English

Topic: Statistical Methods in Clinical Trials

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: bronze

OpenAlex ID: W1974832710