In trials of novel immuno-oncology drugs, the proportional hazards (PH) assumption often
does not hold for the primary time-to-event (TTE) efficacy endpoint, likely due to the unique …

Many clinical research studies evaluate a time‐to‐event outcome, illustrate survival
functions, and conventionally report estimated hazard ratios to express the magnitude of the …

The indirect mechanism of action of immunotherapy causes a delayed treatment effect,
producing delayed separation of survival curves between the treatment groups, and violates …

An assurance calculation is a Bayesian alternative to a power calculation. One may be
performed to aid the planning of a clinical trial, specifically setting the sample size or to …

A delayed treatment effect is often observed in the confirmatory trials for immunotherapies
and is reflected by a delayed separation of the survival curves of the immunotherapy groups …

Indirect mechanisms of cancer immunotherapies result in delayed treatment effects that vary
among patients. Consequently, the use of the log-rank test in trial design and analysis can …

Mann–Whitney-type effect measures are clinically relevant, easy to interpret, and readily
applicable to a wide range of study settings. This article considers estimation of such effect …

Cancer immunotherapy trials are frequently characterized by delayed treatment effects such
that the proportional hazards assumption is violated and the log-rank test suffers a …

The statistical methods are widely needed to support the clinical and biomedical research.
The innovation of medical science often poses challenges on the methodology development …