… randomized versus nonrandomized phase II designs … designs for historically controlled and
randomized phase II trials, along with their advantages, disadvantages, and statistical design …

… In this review, we evaluate the use of randomized phase II (RPh2) trials in studying … designs
and how they are used in cancer clinical trials. We are particularly interested in the design …

… trial, as well as limitations of current designs. We review previously … randomized phase II
study designs, specifically examining phase II selection designs, randomized phase II designs …

… /III designs corresponding to these phase II designs. We review phase II/III trial designs
and provide general recommendations for choosing the design parameters. …

… randomized phase II designs, with a concurrent control arm where necessary, attractive. In
this brief report, we discuss the salient features of the randomized designs for phase II … phase …

… take the actual marker distribution into account when designing the trial. In this article, we
investigate the performance of several phase III clinical trial designs, both for testing the overall …

… is to propose a specific randomized phase II trial design that can be used to … phase II trial
results (Table 1): one, perform a randomized phase III trial with a biomarker-enrichment design; …

… In a randomized Phase II trial setting, Fisher’s exact test is based on the distribution of the …
randomized phase II trial designs based on Fisher’s exact test. Using some example designs, …

… that in the randomized phase II trial setting, adaptivesample size, designs can result in
substantially smaller total sample sizes than simply applying multiple Simon designs in parallel, …

… Until it is routine that such studies are incorporated in phase II designs, we will be held back
in generating hypotheses about which biomarkers look most promising for selecting patients …