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.     

锁模半导体激光器产生带宽极限的超短光脉冲

利用主动锁模技术,以光在外腔中的往返频率调制注入电流,在外腔中加入F-P标准具(Fabry-Perot etalon)后,在国內首次获得了带宽极限的可调谐完全锁模半导体激光超短脉冲。该脉冲源可望用于高速光通信、光孤子通信等领域。     

谈新时期图书馆员的继续教育

从分析太原理工大学图书馆人员现状入手 ,结合国内外图书馆员继续教育发展状况 ,提出图书馆开展继续教育的具体措施 :进行在职教育和在职培训     

森林旅游业实施绿色营销的研究

深刻分析了传统市场营销策略对森林旅游业所产生的负面影响。阐述了森林旅游业实施绿色营销的基本原则 ,并提出相应的实施对策。这些对策主要包括努力塑造绿色企业形象 ,建立新型的绿色管理模式 ,大力开发森林旅游绿色产品和生态道德建设     

浅析影响因子的局限性

目前大量的机构用论文的被引用率、期刊的影响因子和被 SCI收录的情况作为评价个人、期刊和科研机构之影响力或水平高低的一个重要指标。但却忽略了不同学科的特殊性以及学科的规模、发展速度等非科学的因素对影响因子的局限 ,这就形成了对许多专业的不公平评价 ,因而必须对普通的影响因子加以修正     

创业教育探究

创业教育是未来主导性教育体制与教育形态之一 ,它植根于创业概念、创业现象、创业学、创业大赛、创业者的研究之中。创业教育走过了一条从无到有 ,从精英到平民的道路。创业教育的兴起是国际政治、经济、文化、教育、价值竞争的结果     

Bayesian analysis of mixture modelling using the multivariate t distribution

A finite mixture model using the multivariate t distribution has been shown as a robust extension of normal mixtures. In this paper, we present a Bayesian approach for inference about parameters of t-mixture models. The specifications of prior distributions are weakly informative to avoid causing nonintegrable posterior distributions. We present two efficient EM-type algorithms for computing the joint posterior mode with the observed data and an incomplete future vector as the sample. Markov chain Monte Carlo sampling schemes are also developed to obtain the target posterior distribution of parameters. The advantages of Bayesian approach over the maximum likelihood method are demonstrated via a set of real data.     

DBF系统的通道校正技术

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。     

Maintaining the connection: Parenting as a noncustodial father

The purpose of this study was to identify relevant factors associated with the noncustodial father's frequency of contact with his child following divorce. The findings of the research revealed that a combination of demographic, personal characteristics, and psychosocial factors are related to the father's frequency of contact with the child.     

浅谈艺术教育在全面提高大学生素质中的作用

在当代大学素质教育中,艺术教育占重要的地位。通过艺术教育,可以培养广大青年学生良好情感、健康心理、综合能力及良好精神品质等素质,对于促进青年大学生综合素质的全面提高具有重要作用。