Data Blind Review and Analysis Set in Clinical Trial

Abstract

Objectives The balance of confounding factors between treatment groups is supported by intention-to-treat (ITT) principle and this can reduce bias and confounding effects. Therefore clear definition of analysis set and blind review are essential prerequisites to perform statistical analysis. In this paper, we discuss the blind review and analysis set to check carefully the data during a blind review and finalize the statistical analysis set in clinical trials. Methods The concept of ITT principle and ITT set has been often mixed and misused. Based on ITT principle, the definition of proper analysis sets are required to show the efficacy in statistical analysis. The analysis sets must be determined in blind review for data management and quality control. We review the analysis sets, such as FAS, PPS, and Safety set based on ITT principle and present blind review procedures. Conclusions The determination of analysis sets through blind review is a very important procedure to reduce bias and to get appropriate result in randomized clinical trial. Blind review can assure the data quality and that is important prerequisites for statistical analysis. Therefore the role of blind review will be emphasized in clinical trial. Key words: ITT, FAS, PPS, Safety set, Blind review