Behavioral responses of rural and urban greater white-toothed shrews (Crocidura russula) to sound disturbance

Urban Ecosystems - The development of urban areas imposes challenges that wildlife must adapt to in order to persist in these new habitats. One of the greatest changes brought by urbanization has...     

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.     

What is educational entrepreneurship? Strategic action,temporality, and the expansion of US higher education

Theory and Society - The massive expansion of US higher education after World War II is a sociological puzzle: a spectacular feat of state capacity-building in a highly federated polity. Prior...     

Properties of the weighted log‐rank test in the design of confirmatory studies with delayed effects

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.     

税务行政裁量权的理论阐释、行为纠偏与路径选择

税法中不确定概念下的理论空间以及税务行政的实践需求共同营造了税务行政裁量的制度空间，而不规范的税务行政裁量则为不规范的税收执法提供了操作机会。通过对税法文本中不确定概念理论缘由的寻求，以及税收征管中实践动因的梳理，税务行政裁量权的规范化确有必要性。为达成税法运行各司其职中的彼此制衡，有必要强化比例性原则在税务行政裁量中的运用，以此限制税权介入纳税人私域的范围与限度，并提供明确化的宏观指引；利用行政裁量基准“行政自制”与“规则之治”的双重品质，借助标准化的文本修正，为规范化的税收执法预设行为轨迹、构建外在制约并压缩裁量空间；以纳税人的同意权为基础，设计符合税法特殊性的程序规则，形成立体化的纳税人救济路径。最终形成税务行政裁量权积极运作与规范运行的制度环境。     

Can Children Recognize Bodily Expressions of Emotion?

Journal of Nonverbal Behavior - Past research has demonstrated that children understand distinct emotion concepts and can accurately recognize facial expressions of distinct emotions by a young...