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.     

Foreign-born and native-born migration in the U.S.: evidence from linked IRS administrative and census survey records

Journal of Population Research - This paper details efforts to link administrative records from the Internal Revenue Service (IRS) to American Community Survey (ACS) and 2010 Census microdata for...     

零售4.0时代先行发货问题的大数据分析

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省略的语用条件和语用策略

日语会话句式后半部分的省略现象可运用格赖斯的合作原则(Cooperative Principle,简称CP)和利奇的礼貌原则(Politeness Principle,简称PP)来进行诠释,它是人际交流的一种语用策略,但同时需具备语用条件.语言知识语境因素是它的语用条件之一.     

论新闻报道策划的实践意义

新闻报道策划 在近几年的新闻实践中应用非常广泛。就报道主题、整合信息、沟通受众和发挥媒体整体优 势等方面论述了新闻报道策划的实践意义。     

苗族现代化的希望--四川苗族地区小场镇建设问题思考

关于四川苗区现代化问题 ,本文从近代苗族山区开发状凸现苗族住山的经验 ,从当代苗族在山面临的挑战及二十年来改革开放实践所探索出的初俱模式与方向 ,求证苗族地区现代化的最大特点“山”因素 ,旨在提高苗族地区现代化建设的理论认识和层面 ,进而再证少数民族地区改革开放与现代化建设具有其自身的特点和规律。     

电子档案管理探微

电子档案是信息技术不断发展的产物,将逐步成为档案管理的主要对象。在分析我国电子档案管理现状的基础上,文章着重探讨了保证电子档案的凭证性的技术措施和管理措施,同时讨论了如何科学、有效地提供电子档案利用。     

浅析新时期我国人口较少民族的扶贫开发对策

改革开放以来,我国人口较少民族在各方面得到了巨大的发展,然而,由于粗放式发展、自然环境、历史等方面的原因,我国人口较少民族少数地区仍至今存在着不同程度的贫困问题,影响了小康社会的全面实现。本文即围绕我国人口较少民族的部分特殊性,以科学发展观为指导,探讨在新的历史时期我国人口较少民族的扶贫开发对策。