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1.
Proportional hazards are a common assumption when designing confirmatory clinical trials in oncology. This assumption not only affects the analysis part but also the sample size calculation. The presence of delayed effects causes a change in the hazard ratio while the trial is ongoing since at the beginning we do not observe any difference between treatment arms, and after some unknown time point, the differences between treatment arms will start to appear. Hence, the proportional hazards assumption no longer holds, and both sample size calculation and analysis methods to be used should be reconsidered. The weighted log‐rank test allows a weighting for early, middle, and late differences through the Fleming and Harrington class of weights and is proven to be more efficient when the proportional hazards assumption does not hold. The Fleming and Harrington class of weights, along with the estimated delay, can be incorporated into the sample size calculation in order to maintain the desired power once the treatment arm differences start to appear. In this article, we explore the impact of delayed effects in group sequential and adaptive group sequential designs and make an empirical evaluation in terms of power and type‐I error rate of the of the weighted log‐rank test in a simulated scenario with fixed values of the Fleming and Harrington class of weights. We also give some practical recommendations regarding which methodology should be used in the presence of delayed effects depending on certain characteristics of the trial. 相似文献
2.
Bioequivalence (BE) studies are designed to show that two formulations of one drug are equivalent and they play an important role in drug development. When in a design stage, it is possible that there is a high degree of uncertainty on variability of the formulations and the actual performance of the test versus reference formulation. Therefore, an interim look may be desirable to stop the study if there is no chance of claiming BE at the end (futility), or claim BE if evidence is sufficient (efficacy), or adjust the sample size. Sequential design approaches specially for BE studies have been proposed previously in publications. We applied modification to the existing methods focusing on simplified multiplicity adjustment and futility stopping. We name our method modified sequential design for BE studies (MSDBE). Simulation results demonstrate comparable performance between MSDBE and the original published methods while MSDBE offers more transparency and better applicability. The R package MSDBE is available at https://sites.google.com/site/modsdbe/ . Copyright © 2015 John Wiley & Sons, Ltd. 相似文献
3.
政府是污染减排的重要主体,了解其行为对污染减排的作用对提升污染减排效果及实现中国绿色发展具有重要意义。创造性地将政府减排目标纳入研究框架,构建面板门槛模型,从工业污染排放总量的角度分析政府减排目标、产业结构、经济规模等因素对地方污染减排的影响,并用工业污染物强度进行稳健性检验。结果显示,政府减排目标对污染减排的作用存在阶段性不同:经济发展初级阶段,政府减排目标对污染排放总量的作用方向为正; 经济发展水平较高时,作用方向为负; 两者之间存在适应性调整阶段,作用方向具有不确定性,但总体由正向作用向负向作用转变。产业结构对工业污染排放总量的作用方向因污染物种类而异,经济规模对工业污染排放总量作用方向为正。 相似文献
4.
Yutaka Nakamura 《Journal of Risk and Uncertainty》1993,6(1):33-48
This article is concerned with thresholds of discrimination of preference judgments under uncertainty. We establish an axiomatic characterization for a threshold representation, where thresholds are represented by inexact measurement of subjective probabilities, i.e., upper and lower probabilities. Since upper and lower probabilities need not be additive, the representational form adopts the Choquet integration. 相似文献
5.
基于复杂适应系统的作战理论哲学反思 总被引:1,自引:0,他引:1
传统的作战理论与方法已经不能适应像现代信息化战争系统这类充满“活”的个体和变化因素的复杂系统,需要进行理论创新。而复杂适应系统理论是当代系统科学的一个新发展。有望成为创新作战理论的突破口。本文在分析比较作战系统的基础上,认为作战系统实质是复杂的适应系统,作战系统内的作战双方都力图以增强自身的适应性和复杂性,削弱对方的适应性和复杂性取得作战的胜利。 相似文献
6.
描述了影响DBF系统特性的主要因素,研究了阵元间互耦对自适应方向图旁瓣和零深的影响及校正方法,讨论了在DBF阵中校正接收通道幅、相误差和I/Q支路正交误差的技术途径。计算机模拟和测试证明,按照所述方法进行校正可以得到满意的结果。另外,为了减小I/Q支路产生正交误差,建议采用中频直接采样和数字化的接收机方案。 相似文献
7.
Angelo Zanella 《Statistical Methods and Applications》1992,1(1):143-160
Summary For technological applications it can be useful to identify some simple physical mechanisms, which, on the basis of the available
knowledge of the production process, may suggest the most appropriate approach to statistical control of the random quantities
of interest. For this purpose the notion of rupture point is introduced firstly. A rupture point is characterized bym randomly arising out of control states, assumed to be mutually exclusive and stochastically independent. Shewhart's control
charts seem to represent the natural statistical tool for controlling a rupture point; however it is shown that they are fully
justified only when the hazard rates attached to the causes of failure are constant. Otherwise, typically in the presence
of time increasing hazard rates, Shewhart's control charts should be completed by a preventive intervention rule (preventive
maintenance). In the second place, the notion of dynamic instability point is introduced, which is specifically characterized
by assuming that the random quantity of interest is ruled by a stochastic differential equation with constant coefficients.
By discretization, developed according to a possibly new approach, it is shown that the former model reduces to an equation
error model, which is among the simplest used in adaptive control, and thus particularly easy to deal with in regard to parameter
estimation and the definition of the optimum control rule. 相似文献
8.
基于FCM的动态结合全局图像阈值分割 总被引:1,自引:0,他引:1
全局阈值分割对于小目标物效果不理想,动态阈值容易产生阴影等干扰,但综合考虑全局阈值和动态阈值可以达到比较理想的结果。模糊C均值算法用于灰度图像分割是一种非监督模糊聚类后再标定的过程,该文在不明显增加运算量的前提下,利用模糊C均值自动聚类的功能分别得到全局阈值和动态阈值,完成对阈值矩阵的构造和图像的分割。 相似文献
9.
Cathy W. S. Chen F. C. Liu Mike K. P. So 《Australian & New Zealand Journal of Statistics》2008,50(1):29-51
To capture mean and variance asymmetries and time‐varying volatility in financial time series, we generalize the threshold stochastic volatility (THSV) model and incorporate a heavy‐tailed error distribution. Unlike existing stochastic volatility models, this model simultaneously accounts for uncertainty in the unobserved threshold value and in the time‐delay parameter. Self‐exciting and exogenous threshold variables are considered to investigate the impact of a number of market news variables on volatility changes. Adopting a Bayesian approach, we use Markov chain Monte Carlo methods to estimate all unknown parameters and latent variables. A simulation experiment demonstrates good estimation performance for reasonable sample sizes. In a study of two international financial market indices, we consider two variants of the generalized THSV model, with US market news as the threshold variable. Finally, we compare models using Bayesian forecasting in a value‐at‐risk (VaR) study. The results show that our proposed model can generate more accurate VaR forecasts than can standard models. 相似文献
10.
Mohammad Salehi M. George A.F. Seber 《Australian & New Zealand Journal of Statistics》2004,46(3):483-494
Not having a variance estimator is a seriously weak point of a sampling design from a practical perspective. This paper provides unbiased variance estimators for several sampling designs based on inverse sampling, both with and without an adaptive component. It proposes a new design, which is called the general inverse sampling design, that avoids sampling an infeasibly large number of units. The paper provide estimators for this design as well as its adaptive modification. A simple artificial example is used to demonstrate the computations. The adaptive and non‐adaptive designs are compared using simulations based on real data sets. The results indicate that, for appropriate populations, the adaptive version can have a substantial variance reduction compared with the non‐adaptive version. Also, adaptive general inverse sampling with a limitation on the initial sample size has a greater variance reduction than without the limitation. 相似文献