Challenges in the design and conduct of phase III brain tumor therapy trials

Abstract
When is an RCT warranted? When are the results of a phase II study sufficiently compelling to warrant a randomized trial? Randomized controlled trials are initiated when new treatments are found to have antiglioma activity in phase II evaluation. Phase II trials are of two types:(1) those that measure tumor response and (2) those that measure tumor control. In studies of response, treatment is given to patients with visible tumor, and the rate and duration of the response is recorded. …

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