Inference and Decision Making for 21st-Century Drug Development and Approval

ABSTRACT

The cost and time of pharmaceutical drug development continue to grow at rates that many say are unsustainable. These trends have enormous impact on what treatments get to patients, when they get them and how they are used. The statistical framework for supporting decisions in regulated clinical development of new medicines has followed a traditional path of frequentist methodology. Trials using hypothesis tests of “no treatment effect” are done routinely, and the p-value < 0.05 is often the determinant of what constitutes a “successful” trial. Many drugs fail in clinical development, adding to the cost of new medicines, and some evidence points blame at the deficiencies of the frequentist paradigm. An unknown number effective medicines may have been abandoned because trials were declared “unsuccessful” due to a p-value exceeding 0.05. Recently, the Bayesian paradigm has shown utility in the clinical drug development process for its probability-based inference. We argue for a Bayesian approach that employs data from other trials as a “prior” for Phase 3 trials so that synthesized evidence across trials can be utilized to compute probability statements that are valuable for understanding the magnitude of treatment effect. Such a Bayesian paradigm provides a promising framework for improving statistical inference and regulatory decision making.     

Design selection for strong orthogonal arrays

Strong orthogonal arrays (SOAs) were recently introduced and studied as a class of space‐filling designs for computer experiments. An important problem that has not been addressed in the literature is that of design selection for such arrays. In this article, we conduct a systematic investigation into this problem, and we focus on the most useful SOA(n,m,4,2 + )s and SOA(n,m,4,2)s. This article first addresses the problem of design selection for SOAs of strength 2+ by examining their three‐dimensional projections. Both theoretical and computational results are presented. When SOAs of strength 2+ do not exist, we formulate a general framework for the selection of SOAs of strength 2 by looking at their two‐dimensional projections. The approach is fruitful, as it is applicable when SOAs of strength 2+ do not exist and it gives rise to them when they do. The Canadian Journal of Statistics 47: 302–314; 2019 © 2019 Statistical Society of Canada     

用联想神经网络设计的信道均衡器

研究了联想神经网络在数字通信信道均衡器实现中的应用,讨论了其设计方法和设计步骤,给出了计算机模拟结果,并进行了性能比较。研究结果表明:Hopfield联想神经网络实现的信道均衡器具有比传统线性横向均衡器更优越的性能。     

ELAN网络控制系统通信处理时间的测量与分析

针对ELAN嵌入式网络微机控制系统中的实时性问题，给出了ELAN网络系统中的通信处理时间的测量方法，并对网络中的通信处理时间进行了分析，最后提出了代码下装的方法。     

中国网上聊天室中英语语言特征

中国网上英语聊天室中的英语与英语国家聊天室中的英语相比较 ,在某些方面 ,如缩写的使用、句首字母少用大写、句尾少标点等有一些共同的特征。但由于受本族语的影响 ,中国人网上聊天的语言有其独到之处。中国人用英语聊天的目的主要是为了练习语言 ,使英语语言的交际功能减弱。受语言水平所限 ,中国聊天者的会话语言更接近书面语体 ,聊天的内容狭窄且缺乏连续性。网上聊天 ,作为一种新的语言交际方式 ,为英语学习者们提供了另一种学习途径 ,在练习快速英语思维及表达方面有着积极作用     

从计算机英语词汇中的隐喻现象谈构词特点

由于计算机和网络的出现,计算机英语词汇日益增多。有些新词汇是通过联想,经历语义变化及隐喻修饰后产生的。更多的计算机英语词汇是通过赋新、缩略、合成等方法构成的。对它们构词的特点进行分析并找出规律,可便于计算机使用者更好地理解词义。     

多媒体技术与素质教育

多媒体技术有利于开发人的潜能,提高教学质量,培养学生的广泛兴趣,有利于加强德育教育.素质教育需要多媒体技术,需要掌握多媒体技术的教师.造就一支具有创新意识、创新精神、创新能力的高素质教师队伍,是全面落实素质教育的根本保证.     

分形理论在计算机辅助图案造型中的应用研究

本文简单介绍了分形理论的概念和特征，着重阐述了分形理论在图案艺术设计方面的应用和方法。研究设计了计算机辅助图案艺术设计系统的功能和构成。     

Inference for the measurement of poverty in the presence of a stochastic weighting variable

Empirical applications of poverty measurement often have to deal with a stochastic weighting variable such as household size. Within the framework of a bivariate distribution function defined over income and weight, I derive the limiting distributions of the decomposable poverty measures and of the ordinates of stochastic dominance curves. The poverty line is allowed to depend on the income distribution. It is shown how the results can be used to test hypotheses concerning changes in poverty. The inference procedures are briefly illustrated using Belgian data. An erratum to this article can be found at     

统计执法的博弈分析

针对目前中国统计数据失真相当严重并引起社会各界普遍关注的现象，运用博弈论作为分析工具，引入重复博弈研究了统计执法中数据报方与查方的利益冲突关系，从统计执法的角度揭示了统计数据失真的主要原因，并提出了相应的五项对策。