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941.
942.
Recently, molecularly targeted agents and immunotherapy have been advanced for the treatment of relapse or refractory cancer patients, where disease progression‐free survival or event‐free survival is often a primary endpoint for the trial design. However, methods to evaluate two‐stage single‐arm phase II trials with a time‐to‐event endpoint are currently processed under an exponential distribution, which limits application of real trial designs. In this paper, we developed an optimal two‐stage design, which is applied to the four commonly used parametric survival distributions. The proposed method has advantages compared with existing methods in that the choice of underlying survival model is more flexible and the power of the study is more adequately addressed. Therefore, the proposed two‐stage design can be routinely used for single‐arm phase II trial designs with a time‐to‐event endpoint as a complement to the commonly used Simon's two‐stage design for the binary outcome. 相似文献
943.
The coefficient of variation (CV) can be used as an index of reliability of measurement. The lognormal distribution has been applied to fit data in many fields. We developed approximate interval estimation of the ratio of two coefficients of variation (CsV) for lognormal distributions by using the Wald-type, Fieller-type, log methods, and method of variance estimates recovery (MOVER). The simulation studies show that empirical coverage rates of the methods are satisfactorily close to a nominal coverage rate for medium sample sizes. 相似文献
944.
In this study, we propose a new distribution using the quadratic rank transmutation map named as transmuted two-parameter Lindley distribution (TTLD). This distribution is more flexible than the two-parameter Lindley distribution (TLD). The properties of the TTLD are examined, and estimation methods for the parameters of this distribution are discussed. The usefulness of the TTLD is demonstrated on some real data. 相似文献
945.
Characterization of dose‐response for count data using a generalized MCP‐Mod approach in an adaptive dose‐ranging trial
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Francois Mercier Bjoern Bornkamp David Ohlssen Erik Wallstroem 《Pharmaceutical statistics》2015,14(4):359-367
Understanding the dose–response relationship is a key objective in Phase II clinical development. Yet, designing a dose‐ranging trial is a challenging task, as it requires identifying the therapeutic window and the shape of the dose–response curve for a new drug on the basis of a limited number of doses. Adaptive designs have been proposed as a solution to improve both quality and efficiency of Phase II trials as they give the possibility to select the dose to be tested as the trial goes. In this article, we present a ‘shapebased’ two‐stage adaptive trial design where the doses to be tested in the second stage are determined based on the correlation observed between efficacy of the doses tested in the first stage and a set of pre‐specified candidate dose–response profiles. At the end of the trial, the data are analyzed using the generalized MCP‐Mod approach in order to account for model uncertainty. A simulation study shows that this approach gives more precise estimates of a desired target dose (e.g. ED70) than a single‐stage (fixed‐dose) design and performs as well as a two‐stage D‐optimal design. We present the results of an adaptive model‐based dose‐ranging trial in multiple sclerosis that motivated this research and was conducted using the presented methodology. Copyright © 2015 John Wiley & Sons, Ltd. 相似文献
946.
大学生是未来社会建设和发展的生力军,其环保素质直接影响着未来环境事业的发展与成败,进而影响到"两型社会"建设与和谐社会的构建。当前大学生环境教育存在以下问题:重专业,轻普及;教育内容和形式不够丰富;课程体系不够健全;缺乏教育环境的支持。在普及大学生环境教育的过程中要加强认识,将环境教育列入教学计划;整合资源,完善课程体系;丰富形式,重视第二课堂教育。 相似文献
947.
In this paper, we review the adaptive design methodology of Li et al. (Biostatistics 3 :277–287) for two‐stage trials with mid‐trial sample size adjustment. We argue that it is closer in principle to a group sequential design, in spite of its obvious adaptive element. Several extensions are proposed that aim to make it even more attractive and transparent alternative to a standard (fixed sample size) trial for funding bodies to consider. These enable a cap to be put on the maximum sample size and for the trial data to be analysed using standard methods at its conclusion. The regulatory view of trials incorporating unblinded sample size re‐estimation is also discussed. © 2014 The Authors. Pharmaceutical Statistics published by John Wiley & Sons, Ltd. 相似文献
948.
流动研究生党员教育管理的难点及对策 总被引:1,自引:0,他引:1
彭庆刚 《安徽农业大学学报(社会科学版)》2011,20(4):133-136
离开学校到外地学习、实验超过一定时间的研究生党员,在地域、空间的阻隔和繁重学业的压力下,很容易游离于党组织的教育、管理和监督之外,逐渐淡化党员意识。研究生党员是祖国未来建设的中坚力量,全面发挥党支部、研究生导师和流动研究生党员自身的作用,通过校内外研究生党员"双向带动"等方式,加强对"流动研究生党员"的教育和管理,增强他们的党性观念,对于保持研究生党员的先进性,团结和带领广大学生共同进步具有重要的意义。 相似文献
949.
施秋香 《江苏石油化工学院学报(哲学社会科学版)》2011,(4):85-87
围绕人才培养的目标本体,高校文科教师的研究性教育要实现从传授到引导的转变,同时高校文科学生的研究性学习要实现从接受到发现的转变,两种转变相辅相成,互为依托,这是高校文科研究性教学的一体两翼。高校文科研究性教学必须建构起这种一体两翼的平衡模式,才能切实提升教学水平、培养具有科学精神和研究能力的创新人才。 相似文献
950.
刘良训 《榆林高等专科学校学报》2011,21(1):108-110
从运行过程、目标导向及管理原则等因素看,新建本科高校推行ISO质量管理体系是可行的,其不仅可解决"两个评估"的燃眉之急,更益于快速而持续地提高办学水平。但关键是要从管理方针和目标的制定入手,创立一种新的符合新建本科高校实际的质量管理体系。 相似文献