欢迎您！东篱公司
退出
-
申报数据库
-
立项数据库
-
成果数据库
-
项目获奖数据库
中文摘要：
随着临床试验全球化的增长趋势,多中心临床试验已经受到了广泛的关注。其中各个中心治疗效果的一致性评价是多中心临床试验中的一个关键问题。本文系统综述了关于多中心临床试验在评价整体一致性中的常用方法,对一致性评价方法的选择、检验的功效和假阳性的概率以及样本容量与方法之间的关系给出了一些简单的讨论,旨在为从事多中心临床工作者提供借鉴,希望有更多的国内学者关注这一领域的研究,推动多中心临床试验在我国的发展,为新药临床试验提供理论依据。
英文摘要：
The multi-regional clinical trials（MRCTs） have received wide attention with an increasing trend of globalization of clinical trials.A key issue in MRCTs is how to assess the consistency of treatment effect across regions.In this paper,we provide a systematic review of methods that be commonly used for assessing the consistency in MRCTs.We also give some simple discussion about the choice of methods of assessing the consistency of treatment effect across regions,such as the power of the test,the false-positive rate and the relationship between the type I error and the sample size.The purpose of this paper is to provide some reference for the members in designing and conducting MRCTs and offer some theory evidences of clinical trails for new drug development.We hope that more researchers can concern this study in this field,promoting the development of MRCTs in our country.
同期刊论文项目
同项目期刊论文
Strong consistency of estimators in partially linear models for longitudinal data with mixingdepende
Asymptotic properties of wavelet estimators in semiparametric regression models under dependent erro
Outlier Detection in Adaptive Functional-Coefficient Autoregressive Models Based on Extreme Value Th
Empirical likelihood inference in mixtures of semiparametric varying coefficient EV models for longi
Semiparametric regression estimation for longitudinal data in models with martingale difference erro
Testing for the shape parameter of generalized extreme value distribution based on the -likelihood r
Bayesian Inference for Generalized Linear Mixed Model Based on the Multivariate t Distribution in Po
Empirical likelihood for varying-coefficient semiparametric mixed-effects errors-in-variables models
Modified maximum spacings method for generalizedextreme value distribution and applicationsin real d
Diagnostics on nonlinear model with scale mixtures ofskew-normal and first-order autoregressive erro
An approximately optimal non-parametric procedure for analyzing exchangeable binary data with random
Nonparametric estimation in generalizedvarying-coefficient models based on iterativeweighted quasi-l
Orthogonality-projection-based estimation for semi-varyingcoefficient models with heteroscedastic er
Asymptotics of a wavelet estimator in the nonparametricregression model with repeated measurements u
Uniform tail asymptotics for the aggregate claimswith stochastic discount in the renewal risk models
Heteroscedasticity diagnostics invarying-coefficient partially linear regressionmodels and applicati
Heteroscedasticity and/or Autocorrelation Checks in Longitudinal Nonlinear Models with Elliptical an
Empirical likelihood inference in mixture of semiparametric varying-coefficient models for longitudi
The finite-time ruin probability in the presence of Sarmanov dependent financial and insurance risks
期刊信息
位置：