Statistical considerations in clinical trial design with event-free survival as the primary efficacy endpoint

In late-phase confirmatory clinical trials in the oncology field, time-to-event (TTE) endpoints are commonly used as primary endpoints for establishing the efficacy of investigational therapies. Among these TTE endpoints, overall survival (OS) is always considered as the gold standard. However, OS data can take years to mature, and its use for measurement of efficacy can be confounded by the use of post-treatment rescue therapies or supportive care. Therefore, to accelerate the development process and better characterize the treatment effect of new investigational therapies, other TTE endpoints such as progression-free survival and event-free survival (EFS) are applied as primary efficacy endpoints in some confirmatory trials, either as a surrogate for OS or as a direct measure of clinical benefits. For evaluating novel treatments for acute myeloid leukemia, EFS has been gradually recognized as a direct measure of clinical benefits. However, the application of an EFS endpoint is still controversial mainly due to the debate surrounding definition of treatment failure (TF) events. In this article, we investigate the EFS endpoint with the most conservative definition for the timing of TF, which is Day 1 since randomization. Specifically, the corresponding non-proportional hazard pattern of the EFS endpoint is investigated with both analytical and numerical approaches.     

社会主义法治理念在检察工作中的深化与拓展——以检察文化建设为视角

社会主义法治理念是检察文化建设的根本指针,检察文化是社会主义法治理念的有效载体,两者互为依存,相互促进。社会主义法治理念在检察工作中深化与拓展的最终归宿是:符合社会主义法治理念核心要求的检察文化的形成。社会主义法治理念在检察工作中深化与拓展的基本路径是通过检察文化建设实现司法理念从宏观层面向微观层面的转化,即打击犯罪与保障人权相统一、程序正义与实体正义相统一、协作与监督相统一、法律效果与社会效果相统一、案件数量与案件质量相统一。     

A new generalization of the Weibull-geometric distribution with bathtub failure rate

In this paper, the researchers attempt to introduce a new generalization of the Weibull-geometric distribution. The failure rate function of the new model is found to be increasing, decreasing, upside-down bathtub, and bathtub-shaped. The researchers obtained the new model by compounding Weibull distribution and discrete generalized exponential distribution of a second type, which is a generalization of the geometric distribution. The new introduced model contains some previously known lifetime distributions as well as a new one. Some basic distributional properties and moments of the new model are discussed. Estimation of the parameters is illustrated and the model with two known real data sets is examined.     

A multiple warm standby δ-shock system with a repairman having multiple vacations

In this article, a warm standby n-unit system is studied. The system is operational as long as there is one unit normal. The unit online, which has a lifetime distribution governed by a phase-type distribution, is also attacked by a shock from some external causes. Assume that shocks arrive according to a Poisson process. Whenever an interarrival time of shock is less than a threshold, the unit online fails. The lifetimes of the units in warm standby is exponentially distributed. A repairman who can take multiple vacations repairs the failed units based on the “first-in-first-out” rule. The repair times and the vacation times of repairman are governed by different phase-type distributions. For this system, the Markov process governing the system is constructed. The system is studied in a transient and stationary regime; the availability, the reliability, the rates of occurrence of the different types of failures, and the working probability of the repairman are calculated. A numerical application is performed to illustrate the calculations.     

律师伪证罪的困境与出路

《刑法》第306条有关律师伪证罪的规定一直面临着悖逆民心的困境，但其原因并非实体内容不公正，而是欠缺程序上的合理限制，由此导致它沦为检察机关实施职业报复的工具。将律师纪律处分或行政处罚程序作为刑事诉讼程序的程序性前提，把取消会员资格的行业处分或吊销律师职业证书的行政处罚作为刑事诉讼的实体性前提，并限制刑事侦查的调查范围，可以合理地限制检察机关的偏见和恣意，带领该规定走出当前的困境。     

企业无力清偿欠薪的法律应对:基于香港的经验

1980-1982年经济危机爆发后,香港因大量企业倒闭引发欠薪浪潮,欠薪优先权机制出现失灵.以国外经验为模本,香港构设了欠薪保障基金制度.该制度依托完善的法律程序将欠薪纳入专门基金予以垫付,并逐渐提高垫付标准.这种法律设计特点鲜明,实际运行数据也证明比较成功.这为解决当前农民工极端讨薪事件频发、欠薪问题季节性爆发的顽疾,提供了极具参考价值的制度化思路.我国应当鼓励地方探索和构建企业欠薪保障制度.     

基于模糊理论评估连续梁桥地震破坏状况

为了研究不同强度等级地震作用下连续梁桥的破坏模式及破坏程度,采用多级模糊综合评判方法建立连续梁桥的综合评估模型。根据连续梁桥的特点,利用连续梁桥各单元及各构件的破坏程度建立多个因素集,根据各因素的权重和评价标准,对多个因素集进行逐级评判,根据最大隶属度原则得到地震作用下连续梁桥的破坏情况,并通过等级参数评判法对不同地震强度下连续梁桥的破坏情况进行等级评判,得到连续梁桥破坏情况与地震强度之间的关系。最后,基于多级模糊综合评判方法对一座连续梁桥实例进行评判     

论反垄断行政执法程序规则的立法完善

完善的反垄断行政执法程序规则是规范反垄断执法行为的制度基础,我国现行反垄断法执法程序制度体系还存在立法缺陷,亟需通过统一程序规则,规范调查权及行政裁量权的行使,保障程序正义来实现反垄断行政执法程序的立法完善。     

论民事立案登记制审查中的“形式”与“实质”

在近一年实践过程中,我国的立案登记制已略显成效,但也仍然存在不少问题。在立案登记制度是否需要审查,其为形式审查还是实质审查,如何明确立案登记中形式审查的审查标准和范围,如何保持好立案登记形式审查程序与后续的审判与调解程序之间的零缝隙衔接等方面还需要不断完善。只有这样,立案登记制度才能真正实现理论来源于实践并积极作用于实践的良性诉讼循环。