… The sources of variability influencing the results of phase II trials are reviewed. Randomized
designs for phase II testing are presented and evaluated. Phase II designs with "standard …

… related to randomized phase II trial design, our particular focus is on trial designs applicable
… We review previously discussed randomized phase II study designs, specifically examining …

… and randomized phase II trials, … of randomization in phase II studies, the situations in which
the use of historical controls is preferred, and the situations in which the use of randomized …

… Herein, we report the results of a randomized phase II trial that evaluated three doses of
nivolumab to identify a potential dose-response relationship and assess the activity and safety of …

… and phase II/III designs. The barriers to widespread adoption of randomized phase II trials
include … We conclude that randomized phase II trials are a worthy investment considering finite …

… phase III trial, in which the primary outcome and its targeted difference represent direct
clinical benefit to the patient, in a randomized phase II trial, … ); the corresponding phase II–targeted …

… A sequential Bayesian phase II/III design is proposed for comparative clinical trials. The design
… a Bayesian phase II/III treatment evaluation strategy. Patients are randomized between E …

… We consider phase II trials randomizing patients between a prospective control and an … on
type I and II error probabilities. These designs are randomized phase II trial analogs of Simon’…

… sufficiently high power or a small type II error rate). For phase IIB trials, two or more regimens
… In this review, we evaluate the use of randomized phase II (RPh2) trials in studying multiple …

… for a given disease make randomized phase II designs, with a … features of the randomized
designs for phase II trials, which … use of limited phase III financial and patient resources. …