Point/counterpoint: randomized versus single-arm phase II clinical trials for patients with newly diagnosed glioblastoma

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Abstract
In this article, we attempt to delineate the pros and cons of single-arm versus randomized phase II studies in patients with newly diagnosed glioblastoma (GBM), taking into account such factors as (i) the availability of appropriate controls, (ii) the interpretability of the resulting data, (iii) the goal of rapidly screening many novel agents using as few patients as necessary, (iv) utilization of limited financial and patient resources, and (v) maximization of patient participation in these studies.

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