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.     

区块链技术下智能合约之于合同的新诠释

应用于交易领域的智能合约融入区块链技术,以代码形式表现,可实现合同履行的自动化和不可逆,超越了传统意义上的合同模式.自助行为说、代理说将智能合约视为对合同过程的外部增强,是侧面功能的法律阐释,并未完全捕捉到实质.智能合约并不一定跨越整个合同过程,也可仅是合同过程某个方面或某个阶段.法律意义上的智能合约不是合同新类型,而是合同关系形式的新发展,即当事人缔结和履行合同的新形式,合同性质未发生实质变化.智能合约满足特定要件构成特殊的书面形式,具有"书面形式+自动履行"功能的特质.民事主体通过智能合约形式订立合同应遵守《民法典》等现行法律的具体规则,以保证合同依法成立与生效.智能合约不等同于具有法律效力的合同,认定其效力应结合智能合约应用中的具体问题展开具体分析.从立法上确认智能合约,在符合国家现有法律、政策基础上编写和应用,实现形式的合法化、内容的规范化是该技术谋求长远发展的保障.技术起步的现阶段,纸质合同、一般电子合同与智能合约在不同方面发挥协作作用,会在未来一段时间内成为民事交往、商业交易的主要状态.     

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...     

基于WEB的远程教学管理软件分析与设计

本论文主要讨论了基于WEB远程教学管理软件的分析与设计。首先对远程教育与传统教育进行了比较研究,确定远程教育是现代教育发展的方向;其次对开发基于WEB远程教学管理软件进行了环境分析和需求分析;最后讨论了远程教学管理软件的实现,包括软件模块结构设计和网站的总体框架。     

私营企业女工权益保护论

在私营企业中 ，普遍存在着职工合法权益难以保障的问题，尤其是女工权益受侵害的问题更为普遍，也更 为突出。女工权益受侵害的原因，既有社会大环境方面的，也有企业主方面的，还有女工个 人方面的。制定专门的《私营企业法》，明确劳动契约原则，加强工商行政管理部门的管理 职能，加大新闻机构宣传与监督力度等，是有效保护女工合法权益的主要途径。     

四级写作低分段评分样本的功能分析

为了客观、系统地研究大学英语四级低分段写作的基本语法和文体特点 ,有必要从系统功能语法的角度对评分样本进行统计分析。系统功能语法比传统语法具有诸多的优越性 ,能够全面细致地对语言现象进行分析。对评分样本的分析 ,有助于客观地研究克服经验主义倾向     

从WTO规则析我国农业国内支持制度的完善

WTO相关协议允许各国采用一定的农业国内支持措施，尤其是《农产品协定》的绿箱条款更指明了农业国内支持的方向。我国在入世协议中也对农业国内支持作了承诺。为此，要发展农业，应在遵守上述WTO规则的基础上逐步完善我国现行的农业国内支持制度。     

Measuring agreement between two statistics with applications to age standardization

Summary.  We detail a general method for measuring agreement between two statistics. An application is two ratios of directly standardized rates which differ only by the choice of the standard. If the statistics have a high value for the coefficient of agreement then the expected squared difference between the statistics is small relative to the variance of the average of the two statistics, and inferences vary little by changing statistics. The estimation of a coefficient of agreement between two statistics is not straightforward because there is only one pair of observed values, each statistic calculated from the data. We introduce estimators of the coefficient of agreement for two statistics and discuss their use, especially as applied to functions of standardized rates.     

论观点采择与皮亚杰的去自我中心化

关于儿童对个人的心理过程、心理特征的认知的研究始于皮亚杰。皮亚杰提出了“自我中心化”和“去自我中心化”的概念 ,在社会认知发展的研究中占有重要的地位。观点采择的本质特征在于个体认识上的去自我中心化 ,即能够站在他人的角度 ,从他人的角度看待问题。对观点采择的研究是对皮亚杰关于儿童自我中心化和去自我中心化发展研究的继承和发展