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

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

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

关键词: Medical physicsClinical trialSample size determinationRandomized controlled trialMedicine

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

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