期刊： PHARMACEUTICAL STATISTICS, ; ()
In a clinical trial, sometimes it is desirable to allocate as many patients as possible to the best treatment, in particular, when a trial for a rare ......
期刊： PHARMACEUTICAL STATISTICS, ; ()
A biosimilar drug is a biological product that is highly similar to and at the same time has no clinically meaningful difference from licensed product......
期刊： PHARMACEUTICAL STATISTICS, ; ()
The standard log-rank test has been extended by adopting various weight functions. Cancer vaccine or immunotherapy trials have shown a delayed onset o......
期刊： PHARMACEUTICAL STATISTICS, 2020; 19 (5)
In this study, we investigate the concept of the mean response for a treatment group mean as well as its estimation and prediction for generalized lin......
期刊： PHARMACEUTICAL STATISTICS, 2020; 19 (6)
The main objective of a confirmatory multiregional clinical trial (MRCT) is to demonstrate the overall efficacy of test drugs in all participating reg......
期刊： PHARMACEUTICAL STATISTICS, 2020; 19 (6)
In medical studies, it is often observed that a portion of subjects will never experience the event of interest and thus can be treated as cured or lo......
期刊： PHARMACEUTICAL STATISTICS, 2020; 19 (4)
Nonlinear mixed-effects (NLME) modeling is one of the most powerful tools for analyzing longitudinal data especially under the sparse sampling design.......
期刊： PHARMACEUTICAL STATISTICS, 2020; 19 (6)
When designing phase II clinical trials, it is important to construct interim monitoring rules that achieve a balance between reliable early stopping ......
期刊： PHARMACEUTICAL STATISTICS, 2020; 19 (4)
The area between two survival curves is an intuitive test statistic for the classical two-sample testing problem. We propose a bootstrap version of it......
期刊： PHARMACEUTICAL STATISTICS, 2020; 19 (4)
Phase II clinical trials designed for evaluating a drug's treatment effect can be either single-arm or double-arm. A single-arm design tests the null ......
期刊： PHARMACEUTICAL STATISTICS, 2020; 19 (5)
A three-arm trial including an experimental treatment, an active reference treatment and a placebo is often used to assess the non-inferiority (NI) wi......
期刊： PHARMACEUTICAL STATISTICS, 2020; 19 (6)
Competing risks data arise frequently in clinical trials, and a common problem encountered is the overall homogeneity between two groups. In competing......
期刊： PHARMACEUTICAL STATISTICS, 0; ()
Statistical analyses of crossover clinical trials have mainly focused on assessing the treatment effect, carryover effect, and period effect. When a t......
期刊： PHARMACEUTICAL STATISTICS, 0; ()
Covariate adjustment for the estimation of treatment effect for randomized controlled trials (RCT) is a simple approach with a long history, hence, it......
期刊： PHARMACEUTICAL STATISTICS, 0; ()
For oncology drug development, phase II proof-of-concept studies have played a key role in determining whether or not to advance to a confirmatory pha......
