Planning a Bayesian early-phase phase I/II study for human vaccines in HER2 carcinomas

Recent innovative statistical approaches for phase I/II clinical trials allow one to jointly model the toxicity and efficacy of a new treatment, taking into account the information gathered during the trial. Prior probabilities are then updated with interim data and thus predictive probabilities become more accurate as the trial progresses. In this study, prior distribution elicited from a physician's opinion on the available dose levels planned for a vaccination dose-finding trial, with human DNA in patients with HER2-positive tumours in terms of toxicity and therapeutic response is presented and discussed. A simulation study was conducted in order to quantify the impact of the choice of prior on study results, i.e. the recommended dose level at the end of the trial.     

Buckley–James Type Estimator for Censored Data with Covariates Missing by Design

Abstract. The Buckley–James estimator (BJE) is a well‐known estimator for linear regression models with censored data. Ritov has generalized the BJE to a semiparametric setting and demonstrated that his class of Buckley–James type estimators is asymptotically equivalent to the class of rank‐based estimators proposed by Tsiatis. In this article, we revisit such relationship in censored data with covariates missing by design. By exploring a similar relationship between our proposed class of Buckley–James type estimating functions to the class of rank‐based estimating functions recently generalized by Nan, Kalbfleisch and Yu, we establish asymptotic properties of our proposed estimators. We also conduct numerical studies to compare asymptotic efficiencies from various estimators.     

论新时期社会主义意识形态建设

新时期社会主义意识形态建设对于社会可持续发展具有重要意义 ;应坚持以马克思主义为指导 ,确立科学社会主义理想信念和科学的世界观、人生观、价值观 ,加强社会主义道德建设 ;同时应坚持政治与经济、建设与批判、继承与创新、“德治”与“法治”相统一的原则     

情态动词的语用分析

英语情态语法范畴进入了动词语法范畴的总体系.情态动词的情态意义是相互交错,自成体系.与其他动词相比,情态动词主要满足语用和语义的需要;其他动词满足语法的需要.所以,分相论述,探讨情态动词所凝结的语用特征是十分必要的.     

Subgroup analysis and interpretation for phase 3 confirmatory trials: White paper of the EFSPI/PSI working group on subgroup analysis

Subgroup by treatment interaction assessments are routinely performed when analysing clinical trials and are particularly important for phase 3 trials where the results may affect regulatory labelling. Interpretation of such interactions is particularly difficult, as on one hand the subgroup finding can be due to chance, but equally such analyses are known to have a low chance of detecting differential treatment effects across subgroup levels, so may overlook important differences in therapeutic efficacy. EMA have therefore issued draft guidance on the use of subgroup analyses in this setting. Although this guidance provided clear proposals on the importance of pre‐specification of likely subgroup effects and how to use this when interpreting trial results, it is less clear which analysis methods would be reasonable, and how to interpret apparent subgroup effects in terms of whether further evaluation or action is necessary. A PSI/EFSPI Working Group has therefore been investigating a focused set of analysis approaches to assess treatment effect heterogeneity across subgroups in confirmatory clinical trials that take account of the number of subgroups explored and also investigating the ability of each method to detect such subgroup heterogeneity. This evaluation has shown that the plotting of standardised effects, bias‐adjusted bootstrapping method and SIDES method all perform more favourably than traditional approaches such as investigating all subgroup‐by‐treatment interactions individually or applying a global test of interaction. Therefore, these approaches should be considered to aid interpretation and provide context for observed results from subgroup analyses conducted for phase 3 clinical trials.     

Statistical inference for oscillation processes

ABSTRACT

A new model for time series with a specific oscillation pattern is proposed. The model consists of a hidden phase process controlling the speed of polling and a nonparametric curve characterizing the pattern, leading together to a generalized state space model. Identifiability of the model is proved and a method for statistical inference based on a particle smoother and a nonparametric EM algorithm is developed. In particular, the oscillation pattern and the unobserved phase process are estimated. The proposed algorithms are computationally efficient and their performance is assessed through simulations and an application to human electrocardiogram recordings.     

ZnS压致结构相变的第一性原理计算

利用第一性原理计算了闪锌矿结构(ZB)ZnS的压致结构相变.计算结果显示:在压力作用下,ZnS在15.7GPa压力下发生从闪锌矿结构到岩盐矿结构(RS)的转变;在74.4GPa压力下,发生了从岩盐矿结构到正交结构相(Orth)的转变;随着结构的转变,其能带结构和晶胞体积也发生了明显的变化,ZnS的导电性发生了从半导体到导体再到半导体的转变.     

干涉ISAR三维成像试验研究

阐述了干涉式逆合成孔径雷达(ISAR)三维成像的基本原理,与传统的ISAR二维成像方法的性能进行了比较.结合实际的宽带雷达平台,介绍了试验验证的基本方法,并通过静态双散射点和过航飞机等目标的实际跟踪试验,获取了目标回波信号的和、方位差和俯仰差三通道宽带数据,给出了干涉ISAR三维成像的算法流程.采用干涉ISAR三维成像的算法对实际测量数据进行了处理,得到了各类目标的成像结果,对成像效果进行了分析和评估,提出了工程应用的建议.     

流动注射-固相萃取-光度法测定环境水样中的Cr（Ⅵ）

用香烟过滤嘴制为材料自制了固相萃取柱,结合流动注射,建立了环境水样中Cr（Ⅵ）光度测定方法.对该方法进行优化,在Cr（Ⅵ）浓度0.1～4.0μg/L范围内具有较好的线性关系,1.0μg/L的Cr（Ⅵ）标样经11次测量,相对标准偏差为4.3%,方法检出限为0.02μg/L.对实际水样进行检测,加标回收率在94%～110%之间.     

中美比较思想政治教育的形成与发展

中美比较思想政治教育是一门年轻的学科,始于20世纪80年代中期。经过20多年的发展,逐步形成了学科体系。从1986年至今,中美比较思想政治教育的形成与发展大致可以分为三个阶段：1986年到1995年时期以区域性研究起步的奠基阶段,1996年到2005年时期以＂借鉴＂为特征的拓展阶段,2006年至今以＂分析＂为特征的深化阶段。以区域研究起步,对美国思想政治教育现象进行介绍和借鉴,进而深入的比较和分析现象背后的原因和力量,试图以此找到思想政治教育的共性、特殊性,有效实现美国经验的＂本土化＂。