Abstract Purpose of Review Innovative clinical trial designs for glioblastoma (GBM) are
needed to expedite drug discovery. Phase 0, window of opportunity, and adaptive designs …

In February 2010, the US Food and Drug Administration (FDA,) drafted guidance that
discusses the statistical, clinical, and regulatory aspects of various adaptive designs for …

This book aids in identifying when to apply adaptive randomization designs in practice.
Featuring contributions from statisticians, clinical trialists, and subject-matter experts in …

One of the fundamental questions in the design of clinical trials is how to optimally allocate
treatments to study subjects to achieve selected experimental objectives. In this article we …

Optimization of clinical trial designs can help investigators achieve higher quality results for
the given resource constraints. The present paper gives an overview of optimal designs for …

Balanced allocation of patients across treatments is a widely adopted and practical strategy
in clinical trials. Under the assumption of variance homogeneity, a balanced allocation is …

Equal randomization has been a popular choice in clinical trial practice. However, in trials
with heterogeneous variances and/or variable treatment costs, as well as in settings where …

Adaptive designs are increasingly developed and used to improve all phases of clinical
trials and in biomedical studies in various ways to address different statistical issues. We first …

Covariate-adjusted response-adaptive (CARA) randomization is used in clinical trials to
balance the competing goals of assigning a greater number of study subjects to the better …

A variety of response-adaptive randomization procedures have been proposed in literature
assuming binary outcomes. However, the list is not so long for continuous outcomes though …