Phase 1 dose-escalation trials are crucial to drug development by providing a framework to
assess the toxicity of novel agents in a stepwise and monitored fashion. Despite widely …

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 …

PURPOSE For immunotherapy, such as checkpoint inhibitors and chimeric antigen receptor
T-cell therapy, where the efficacy does not necessarily increase with the dose, the maximum …

Specification of the prior distribution for a Bayesian model is a central part of the Bayesian
workflow for data analysis, but it is often difficult even for statistical experts. In principle, prior …

The accumulation of immune-suppressive myeloid cells is a critical determinant of
resistance to anti–programmed death-1 (PD-1) therapy in advanced clear cell renal cell …

The primary objective of phase I oncology trials is to find the MTD. The 3+ 3 design is easy to
implement but performs poorly in finding the MTD. A newer design, such as the modified …

Background: The basket trial evaluates the treatment effect of a targeted therapy in patients
with the same genetic or molecular aberration, regardless of their cancer types. Bayesian …

In the era of immunotherapies and targeted therapies, the focus of early phase clinical trials
has shifted from finding the maximum tolerated dose to identifying the optimal biological …

We propose a flexible Bayesian optimal phase II (BOP2) design that is capable of handling
simple (eg, binary) and complicated (eg, ordinal, nested, and co‐primary) endpoints under a …

Background Conventional phase I algorithms for finding a phase-2 recommended dose
(P2RD) based on toxicity alone is problematic because the maximum tolerated dose (MTD) …