Values of interim analysis in drug clinical trials studies

Abstract

Abstract: An interim analysis is any analysis intended to compare the efficacy or safety at any time before formal completion of a trial, and it is seen as a powerful tool in new drug development.The goal of an interim analysis is to stop the trial early if the superiority of the treatment under study is clearly established, or if the demonstration of a relevant treatment difference has become unlikely, or if unacceptable adverse effects are apparent.Interim analysis design has been widely and successfully used in large, long-term trials, and it can prevent certain types of bias and result in a 30 to 40 percent reduction in average sample size with no appreciable decrease in type I error or power.

Key words: clinical trial, interim analysis, data safety monitoring board(DSMB), adverse drug reaction (ADR), fixed sample design

CLC Number:

R311

LI Xian-tao, LIANG Wei-xiong, WANG Qi, WEN Ze-huai. Values of interim analysis in drug clinical trials studies[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2005, 10(1): 112-115.

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