Adaptive designs for single‐arm phase II trials in oncology

Clinical phase II trials in oncology are conducted to determine whether the activity of a new anticancer treatment is promising enough to merit further investigation. Two‐stage designs are commonly used for this situation to allow for early termination. Designs proposed in the literature so far have the common drawback that the sample sizes for the two stages have to be specified in the protocol and have to be adhered to strictly during the course of the trial. As a consequence, designs that allow a higher extent of flexibility are desirable. In this article, we propose a new adaptive method that allows an arbitrary modification of the sample size of the second stage using the results of the interim analysis or external information while controlling the type I error rate. If the sample size is not changed during the trial, the proposed design shows very similar characteristics to the optimal two‐stage design proposed by Chang et al. (Biometrics 1987; 43:865–874). However, the new design allows the use of mid‐course information for the planning of the second stage, thus meeting practical requirements when performing clinical phase II trials in oncology. Copyright © 2012 John Wiley & Sons, Ltd.     

Model averaging for treatment effect estimation in subgroups

In many clinical trials, biological, pharmacological, or clinical information is used to define candidate subgroups of patients that might have a differential treatment effect. Once the trial results are available, interest will focus on subgroups with an increased treatment effect. Estimating a treatment effect for these groups, together with an adequate uncertainty statement is challenging, owing to the resulting “random high” / selection bias. In this paper, we will investigate Bayesian model averaging to address this problem. The general motivation for the use of model averaging is to realize that subgroup selection can be viewed as model selection, so that methods to deal with model selection uncertainty, such as model averaging, can be used also in this setting. Simulations are used to evaluate the performance of the proposed approach. We illustrate it on an example early‐phase clinical trial.     

论西夏的司法制度

西夏的行政、军事机关,一般都兼有案件审判和督察复核职责。司法诉讼主要为刑事诉讼,即使民事案件,也是用刑事判断。对人犯的逮捕只需长官的指令,而不履行法律手续。法律上只有对逮捕人的督察,防其奸伪、贪纵、暴掠以及无故杀伤人犯,人犯拒捕反抗格杀勿论。     

Randomization tests in recursive response-adaptive randomization procedures

In a randomized clinical trial, response-adaptive randomization procedures use the information gathered, including the previous patients' responses, to allocate the next patient. In this setting, we consider randomization-based inference. We provide an algorithm to obtain exact p-values for statistical tests that compare two treatments with dichotomous responses. This algorithm can be applied to a family of response adaptive randomization procedures which share the following property: the distribution of the allocation rule depends only on the imbalance between treatments and on the imbalance between successes for treatments 1 and 2 in the previous step. This family includes some outstanding response adaptive randomization procedures. We study a randomization test to contrast the null hypothesis of equivalence of treatments and we show that this test has a similar performance to that of its parametric counterpart. Besides, we study the effect of a covariate in the inferential process. First, we obtain a parametric test, constructed assuming a logit model which relates responses to treatments and covariate levels, and we give conditions that guarantee its asymptotic normality. Finally, we show that the randomization test, which is free of model specification, performs as well as the parametric test that takes the covariate into account.     

长江三角洲城市群洪涝灾害脆弱性评估及影响因素分析

长江三角洲城市群人口、财产、基础设施高度密集,暴雨洪涝灾害带来的影响越来越大,对该区域城市洪涝灾害脆弱性进行评估是保障长江三角洲区域一体化、可持续发展的基础。以长江三角洲城市群中心区27个城市为研究对象,基于超效率DEA模型,将洪涝灾害脆弱性看作一个负面“生产活动”,构建城市洪涝灾害脆弱性评估模型,在分析脆弱性空间分异特征的基础上确定该地区城市洪涝灾害脆弱性的主要影响因素。结果显示：从整体上看,长江三角洲城市群洪涝灾害脆弱性水平差异较大,安徽及浙江远高于江苏和上海,其中,上海的洪灾脆弱性最低;从空间上看,脆弱性分布有明显的地域集聚特征,脆弱性高的城市分布在浙江东南沿海和安徽南部丘陵地区;降雨量、城市发展水平及基础设施的完善性等因素对城市洪涝灾害脆弱性影响显著。     

论审判对象的变更及其控制

在强调诉审分离的近现代诉讼构造下,无论法官还是控诉方,其权力均被设定了合理的界限与范围,体现一种分权制衡的机理,显示一种对被告人防御权利的保障的理路。审判对象发生合理的变更,主要基于两种理路,一是“起诉变更主义”,二是“审判对象狭义论”,进而表现为内容、性质及方式上若干类型的变更。面对审判对象变更,利益受影响最大者是被告人,故而要将审判对象变更控制在合理限度内与正当程序中,有效防范突袭性审判的发生。我国现行审判对象变更实践缺乏合理的控制机制,并常常表现为法院与检察院的一种“沟通”,当务之急是要完善审判对象变更程序,对审判对象变更实行正当性控制。     

电子审务的架构与程式——基于民事诉讼程序的研究

信息技术和互联网的发展,对各个领域都产生了一定的影响.民事诉讼活动可以在一定程度上运用网络技术,但需要对适用的范围加以界定.电子审务对于降低诉讼成本,更好保护当事人诉讼权利都具有一定的意义.民事诉讼法的修改应该顺应这一潮流,在立法上保留一定的前瞻性.     

浅析袁隆平的科研方法

袁隆平是当代杰出的农业科学家,被国际同行誉为"杂交水稻之父".他在水稻杂交优势利用的开创和发展方面成就卓越.从科学方法而言,袁隆平院士在科研中成功运用了信息联想、辨证分析、试验探索、灵感思维等方法.     

审判独立与抗诉监督制度的完善

司法公正需要审判独立和对审判权实施监督两方面的共同支撑。根据我国的政治体制和司法现状,检察权对审判权的监督必不可少,检察监督与审判独立之间既相互冲突又相互统一。在改造抗诉监督制度时,必须坚持“不损害独立审判权”的底线,把抗诉理由的标准由“确有错误”修改为“认为有错误”,把抗诉范围限定在“损害国家利益和社会公益”的案件和“适用法律错误”的案件,并对抗诉期间和抗诉次数作出严格限制以维护审判结果的终局性和权威性。     

铭文集释及西周诬告案件的审理程序窥探

西周时期没有专门的法律条文, 是一篇涉法铭文,其中涉及到的犯罪是诬告罪。本文在对铭文进行集释和翻译的基础上,总结出这次诬告案件的审理程序,这有助于了解西周时期的法律情况。