The International Conference on Harmonization guideline "Statistical Principles for Clinical Trials": Issues in applying the guideline in practice
The International Conference on Harmonization guideline "Statistical Principles for Clinical Trials": Issues in applying the guideline in practice
复制标题
DOI：
10.1177/009286150003400202
复制
发表时间：
2000-04-01
影响因子：
--
通讯作者：
Morgan, D
中科院分区：
文献类型：
--
作者：
Phillips, A;Ebbutt, A;Morgan, D
国际协调会议（ICH）指南“临床试验统计原则”于1998年3月由专利药品委员会通过，因此在欧洲实施。1998年10月，制药行业统计员（PSI）在伦敦举行了为期一天的讨论，会议的目的是讨论统计员如何应对指南中的一些问题，并记录存在的共识。参加论坛的有工业、学术和监管统计人员。本文件概述了提出的问题、讨论结果和达成的共识。
The International Conference on Harmonization (ICH) guideline "Statistical Principles for Clinical Trials" was adopted by the Committee for Proprietary Medicinal Products in March 1998, and consequently is operational in Europe. In October 1998 a one-day discussion for urn a,as held in London by Statisticians in the Pharmaceutical Industry (PSI), The aim of the meeting was to discuss how, statisticians were responding to some of the issues in the guideline, and to document consensus views where they existed. The forum was attended by industrial, academic, and regulatory statisticians. This paper outlines the questions raised, resulting discussions, and consensus views reached.