摘要
出于对目前新药临床试验的形势要求 ,使试验在技术上能与国际协调会议 (ICH)与GCP相衔接。本文介绍新药临床试验的中间分析和成组序贯试验。应用该方法一般能节约病例数 2 0 %以上 ,因此也节约了时间与费用。本文应用较浅近的方法介绍如何使用中间分析及用绘图法使用成组序贯试验 ,并介绍与固定样本试验法的比较 ,从而使读者能了解其优越性以使在新药临床试验中有较大的获益。
In view of the present trends of new drug clinical trials and the necessity of the statistical techniques coinciding with International Conference of Harmonization(ICH) and GCP. This paper introduces the interim analysis and group sequential trials in clinical experimentations. The advantage of using these techniques over the usual fixed sample size test may allow a substantial reduction of 20 % patients, and subsequently saving experimental time and costs.This paper recommends the methods in a simple, comprehensible and convenient way so that its advantage may be thoroughly exploited by clinical researchers.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2002年第4期245-248,共4页
Chinese Journal of New Drugs and Clinical Remedies
