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.     

高性能可重构DSP处理器的数据通路设计

介绍了高性能定点可重构DSP处理器的数据通路设计。该数据通路以功能强大的16位定点计算单元为基础,搭建起高速16位数据处理平台;并能以单指令流多数据流的方式灵活支持多维向量运算;通过重构的方法有效地支持了32位数据处理。     

小波分析在管理数据处理中的应用

提出了一种基于小波变换的管理数据处理方法，把公司管理上的数据看成一个非平稳的时间序列，利用小渡函数将该时间序列分解到不同的频率通道上，然后将分解后的信号当作近似的平稳时间序列，用一些传统的统计方法进行预测，同时对中国足球彩票若干期的销售量数据进行了处理和预测，并将结果与实际销量以及用传统的AR模型的预测值进行了比较。     

基于TMS320C40的FFT算法改进及应用

讨论了充分利用C4 0的硬件并行结构进行实数FFT的并行算法 ,并在地震勘探信号处理中得以应用     

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     

超深亚微米信号串扰分析

芯片设计进入深亚微米后,互连线效应(主要是信号串扰)对集成电路的影响越来越大。该文针对这种影响进行了分析,讨论了在不考虑耦合电容和考虑耦合电容的两种情况下噪声产生机理,建立了一个耦合电容分析模型,得出了噪声产生的原因,并提出了解决噪声的策略。根据设计实例并结合建立的模型,提出了实际芯片设计中有效地控制串扰的方法,取得了良好的效果。     

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。     

采用二阶特征窗的语音盲分离方法

利用语音信号的短时平稳特性,提出了一种二阶特征窗语音盲分离方法。该方法采用新的联合差分相关矩阵白化算法去除有色噪声影响;用长度等于语音信号基音周期的等距特征窗连续分割预白化观测数据,在每个加窗的数据帧计算不同的时滞协方差矩阵。利用联合近似对角化时滞协方差矩阵集合得到旋转参数,最终达到语音信号的盲分离。该方法消除了有色噪声的影响,只需用到二阶信息就能很好地分离语音信号。仿真实验验证了该方法的有效性。     

FDI的工资效应研究——基于江苏省制造业面板数据的分析

利用江苏省制造业2000--2006年的面板数据，从行业角度分析FDI对于江苏省制造业平均工资以及国有企业工资的影响，结果表明外资企业的进入可以通过提高整体的劳动生产率水平从而间接提高整体平均工资水平；劳动力工资与加工贸易的开放程度之间呈正相关关系，而与行业规模大小呈负相关．外资对于国有企业劳动力工资存在正的工资溢出，但是国内资本对于劳动力工资水平的影响与外商直接投资相比相差不大，甚至可以超过外商直接投资的贡献。     

Empirical Non-Parametric Control Charts: Estimation Effects and Corrections

Owing to the extreme quantiles involved, standard control charts are very sensitive to the effects of parameter estimation and non-normality. More general parametric charts have been devised to deal with the latter complication and corrections have been derived to compensate for the estimation step, both under normal and parametric models. The resulting procedures offer a satisfactory solution over a broad range of underlying distributions. However, situations do occur where even such a large model is inadequate and nothing remains but to consider non- parametric charts. In principle, these form ideal solutions, but the problem is that huge sample sizes are required for the estimation step. Otherwise the resulting stochastic error is so large that the chart is very unstable, a disadvantage that seems to outweigh the advantage of avoiding the model error from the parametric case. Here we analyse under what conditions non-parametric charts actually become feasible alternatives for their parametric counterparts. In particular, corrected versions are suggested for which a possible change point is reached at sample sizes that are markedly less huge (but still larger than the customary range). These corrections serve to control the behaviour during in-control (markedly wrong outcomes of the estimates only occur sufficiently rarely). The price for this protection will clearly be some loss of detection power during out-of-control. A change point comes in view as soon as this loss can be made sufficiently small.