Background: Despite positive preclinical studies and two positive Phase II clinical trials, two
large Phase III clinical trials of progesterone treatment of acute traumatic brain injury (TBI) …

This paper presents a brief overview of the recent literature on adaptive design of clinical
trials from a Bayesian perspective for statistically not so sophisticated readers. Adaptive …

The severe acute respiratory syndrome coronavirus 2 pandemic has drastically altered all
facets of clinical care and research. Clinical research in hepatology has had a rich tradition …

Drug development enterprise is struggling because of prohibitively high costs and slow
progress. There is urgent need for adoption of novel adaptive designs to improve the …

Venetoclax is a highly selective, potent BCL-2 inhibitor that is approved for some patients
previously treated for chronic lymphocytic leukemia, and has shown promising activity in …

Seamless phase I/II dose‐finding trials are attracting increasing attention nowadays in early‐
phase drug development for oncology. Most existing phase I/II dose‐finding methods use …

In dose-finding trials of chemotherapeutic agents, the goal of identifying the maximum
tolerated dose is usually determined by considering information on toxicity only, with the …

Monitoring patient safety during clinical trials is a critical component throughout the drug
development life-cycle. Pharmaceutical sponsors must work proactively and collaboratively …

This article proposes a phase I/II clinical trial design for adaptively and dynamically
optimizing each patient's dose in each of two cycles of therapy based on the joint binary …

Binge-eating disorder (BED) is a psychiatric disorder characterized by recurrent episodes of
eating a large amount of food in a discrete period of time while experiencing a loss of …