Designing clinical trials that accept new arms: an example in metastatic breast cancer

J Clin Oncol

22 May 2017 - The majority of randomised oncology trials are two-arm studies that test the efficacy of new therapies against a standard of care, thereby assigning a large proportion of patients to non-experimental therapies. 

In contrast, multi-arm studies efficiently share a common control arm while evaluating multiple experimental therapies. A major bottleneck for traditional multi-arm trials is the requirement that all therapies—often drugs from different companies—have to be available at the same time when the trial starts. 

We evaluate the potential gains of a platform design—the rolling-arms design—that adds and removes arms on a rolling basis.

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Michael Wonder

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Michael Wonder