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.     

Ethical Numbers: Ethics Training in U.S. Graduate Statistics Programs, 2013–2014

As important members of research teams, statisticians bear an ethical responsibility to analyze, interpret, and report data honestly and objectively. One way of reinforcing ethical responsibilities is through required courses covering a variety of ethics-related topics at the graduate level. We assessed ethics requirements for graduate-level statistics training programs in the United States for the 2013–2014 academic year using the websites of 88 universities, examining 103 biostatistics programs, and 136 statistics degree programs. We categorized programs’ ethics training requirements as required or not required. Thirty-one (35.1%) universities required an ethics course for at least some degree students. Sixty-two (25.5%) degree programs required an ethics course for at least some students. The majority (77.4%) of required courses were worth 0 or 1 credit. Of the 177 programs without an ethics requirement, 19 (10.7%) listed an ethics elective. Although a single ethics course is insufficient for instilling an ethical approach to science, degree programs that model expectations through coursework point to the value of ethics in science. More training programs should prepare statisticians to consider the ethical dimensions of their work through required coursework. Supplementary materials for this article are available online.     

储层岩石矿物成分对酸蚀裂缝导流能力的影响

储层岩石矿物成分是酸压改造效果影响因素之一。研究认为，在储层岩石矿物成分中易溶物的含量及分布方式决定了酸蚀裂缝导流能力大小，易溶蚀物的含量越多，岩石溶蚀速率越快。室内测试了不同溶蚀速率下的灰岩和白云岩的酸蚀裂缝导流能力，研究了岩石溶蚀速率、易溶蚀物含量对酸蚀裂缝导流能力的影响，对酸压工艺设计方案提出了指导性建议。研究结果表明，储层岩石溶蚀速率与酸蚀裂缝导流能力增加倍比存在抛物线关系，易溶蚀物占30%40% 时酸蚀裂缝导流能力保持较好。     

Sex Related Factors in the Perception of Threatening Facial Expressions

This study replicated and extended previously reported sex differences involving both viewer and target in the recognition of threatening facial expressions. Based on the assumption that the evolved cognitive mechanisms mediating anger recognition would have been designed by natural selection to operate quickly in the interests of survival, brief tachistoscopic presentation of stimulus photographs was used. Additionally, in contrast to prior published studies, the statistical methods of signal detection research were used to control for the confounding effects of non-random guessing. The main hypothesis, that anger posed by males would be more accurately perceived than anger posed by females, was supported. A secondary hypothesis, that female-posed anger would be more accurately perceived by women than by men, received partial support. Testosterone levels, measured inferentially in terms of diurnal cycles, failed to show the hypothesized positive relationship to accuracy of anger perception.     

Adolescent Protective Factors Promoting Resilience in Young Adults at Risk for Depression

In a longitudinal, community-based study, adolescent protective factors for those at risk for depression were identified that were associated with resilient outcomes in young adulthood. For those with childhood risk factors for major depression, significant protective factors included family cohesion, positive self appraisals, and good interpersonal relations. Findings may help inform the development of prevention and treatment programs for adolescents vulnerable to depression. Implications for future research and clinical practice are discussed.     

腔内电光调制激光系统的混沌模拟

采用数值模拟的方法讨论了带反馈的腔內电光调制激光系统功率输出的分叉和混沌行为,得到了输出功率随控制参数变化的分叉图,和一些定量结果。     

绍兴市贷款产出效率分析

通过对1991-2004年绍兴市实现的GDP与占用贷款变动关系的统计分析,指出贷款产出效率持续走低存在的问题,在分析了贷款产出效率下降的主要原因后,提出了相应的对策建议.     

Why sociology does not need to be saved: Analytic reflections on public sociologies

After reviewing the debate about public sociologies in the American Sociological Association over the past few years, we offer a response to calls for “saving sociology” from the Burawoy approach as well as an analytic critique of the former ASA president's “For Public Sociology” address. While being sympathetic to the basic idea of public sociologies, we argue that the “reflexive” and “critical” categories of sociology, as Burawoy has conceptualized them, are too ambiguous and value-laden to allow for empirical investigation of the different major orientations of sociological research and the ways the discipline can address non-academic audiences. Debates about the future of sociology should be undertaken with empirical evidence, and we need a theoretical approach that can allow us to compare both disciplines and nations as well as taking into account the institutional context of the universities in which we operate. Research into the conditions under which professional, critical, policy, and public sociologies could work together for the larger disciplinary and societal good is called for instead of overheated rhetoric both for and against public sociologies.     

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。