How to plan and execute an interim analysis in clinical trial

Abstract

Abstract: Investigators routinely perform an interim analyses to evaluate data in a clinical trial before its completion, because the trial begins with uncertainty of safety and efficacy in the proposed treatment.An interim analysis is a logical part of the trial design.This article describes how to plan and execute an interim analysis, and discusses the responsibilities of involved members.

Key words: interim analysis, data safety monitoring board, clinical trial, double blind

CLC Number:

R969

LI Xian-tao, LIANG Wei-xiong, WANG Qi, WEN Ze-huai. How to plan and execute an interim analysis in clinical trial[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2005, 10(2): 234-237.

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