Sample size re-estimation for survival data in clinical trials with an adaptive design [0.03%]
具有自适应设计的临床试验中的生存数据样本量重新估计方法研究
Kanae Togo,Manabu Iwasaki
Kanae Togo
In clinical trials with survival data, investigators may wish to re-estimate the sample size based on the observed effect size while the trial is ongoing. Besides the inflation of the type-I error rate due to sample size re-estimation, the ...
J L Sebaugh
J L Sebaugh
This article provides minimum requirements for having confidence in the accuracy of EC50/IC50 estimates. Two definitions of EC50/IC50s are considered: relative and absolute. The relative EC50/IC50 is the parameter c in the 4-parameter logis...
Type I error rate control in adaptive designs for confirmatory clinical trials with treatment selection at interim [0.03%]
期中选择治疗的确认性临床试验中自适应设计的Ⅰ类错误率控制
Martin Posch,Willi Maurer,Frank Bretz
Martin Posch
Interest in confirmatory adaptive combined phase II/III studies with treatment selection has increased in the past few years. These studies start comparing several treatments with a control. One (or more) treatment(s) is then selected after...
Asymptotic properties of mean survival estimate based on the Kaplan-Meier curve with an extrapolated tail [0.03%]
基于Kaplan-Meier曲线（含外推尾部）的平均生存期估计的渐近性质
Qi Gong,Liang Fang
Qi Gong
Asymptotic distribution of the mean survival time based on the Kaplan-Meier curve with an extrapolated 'tail' is derived. A closed formula of the variance estimate is provided. Asymptotic properties of the estimator were studied in a simula...
Statistical analysis of data from dilution assays with censored correlated counts [0.03%]
截断相关计数的稀释实验数据的统计分析
Jorge Quiroz,Jeffrey R Wilson,Satrajit Roychoudhury
Jorge Quiroz
Frequently, count data obtained from dilution assays are subject to an upper detection limit, and as such, data obtained from these assays are usually censored. Also, counts from the same subject at different dilution levels are correlated....
Admissible two-stage designs for phase II cancer clinical trials that incorporate the expected sample size under the alternative hypothesis [0.03%]
一种新的期II临床试验两阶段设计：在备择假设下考虑预期样本量的可接受性设计
Adrian P Mander,James M S Wason,Michael J Sweeting et al.
Adrian P Mander et al.
Two-stage studies may be chosen optimally by minimising a single characteristic like the maximum sample size. However, given that an investigator will initially select a null treatment effect and the clinically relevant difference, it is better...
An examination of the relative impact of type I and type II error rates in phase II drug screening trial queues [0.03%]
I类与II类错误率在二期药物筛选试验中的相对影响分析
Alan D Hutson,Gregory E Wilding
Alan D Hutson
In this note, we highlight the fact that the choice of type I and type II error rates should not simply be set at traditional levels in the phase II clinical trial setting when considering the relative success rate of previous trials in a g...
Operating characteristics of a Simon two-stage phase II clinical trial design incorporating continuous toxicity monitoring [0.03%]
基于连续毒性监测的Simon两阶段二期临床试验设计的运行特性分析
H E Ray,S N Rai
H E Ray
Phase II clinical trials are usually designed to measure efficacy, but safety is also an important end point. Previous authors recommended a method to monitor toxic events after each patient is enrolled, which is also known as continuously ...
Exact sample-size determination in testing non-inferiority under a simple crossover trial [0.03%]
简略交叉设计下检验非劣效性的样本量精确确定方法
Kung-Jong Lui,Kuang-Chao Chang
Kung-Jong Lui
For testing the non-inferiority (or equivalence) of an experimental treatment to a standard treatment, the odds ratio (OR) of patient response rates has been recommended to measure the relative treatment efficacy. On the basis of an exact t...
Comparative Study
Pharmaceutical statistics. 2012 Mar-Apr;11(2):129-34. DOI:10.1002/pst.506 2012
Mario Hasler
Mario Hasler
This paper addresses multiple comparisons in the presence of both a negative and a positive control. The methodology of the three-arm trial is extended to the case of many experimental treatment arms or different doses of a compound. In con...