Immune checkpoint inhibitor (ICI) therapy targeting anti-programmed cell death-1 (anti-PD-
1) or its ligand (anti-PD-L1) is the backbone of numerous combination regimens aimed at …

Health-related quality of life (HRQoL) is a subjective measure of patients' experience of
disease and treatment. We systematically reviewed the literature to identify high quality …

Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical
industry, academia, and regulatory agencies, this volume explores the rapidly growing area …

Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology,
Second Edition explores statistics used in day-to-day clinical pharmacology work. The book …

There are quite a few disorders for which regulatory agencies have required a treatment to
demonstrate a statistically significant effect on multiple endpoints, each at the one-sided …

A common approach to analysing clinical trials with multiple outcomes is to control the
probability for the trial as a whole of making at least one incorrect positive finding under any …

While current guidelines generally recommend single endpoints for primary analyses of
confirmatory clinical trials, it is recognized that certain settings require inference on multiple …

Clinical trials often employ two or more primary efficacy endpoints. One of the major
problems in such trials is how to determine a sample size suitable for multiple co‐primary …

Multiple testing problems in regulatory applications are often more challenging than the
problems of handling a set of mathematical symbols representing multiple null hypotheses …

The discovery of somatic mutations, primarily JAK2V617F and CALR, in classic BCR-ABL1-
negative myeloproliferative neoplasms (MPNs) has generated interest in the development of …