BSWG KOL Lecture Series, L22

Event Date:



Speaker: Hui Quan, PhD (Sanofi)
Title: Historical control data borrowing for non-inferiority assessment

Non-inferiority (NI) assessment is often performed to evaluate whether a test treatment can preserve certain proportion of the treatment effect of an active control compared to placebo. Two methods are usually applied for the NI assessment. One is the so-called synthesis method and the other is the two-confidence-interval method. To fully utilize available information, historical data of the active control may be borrowed not just for the NI margin specification but also for the actual NI assessment. In that case, the historical data will be used twice which may create some concern. Moreover, as the historical data have already been observed and fixed when the current NI trial is designed, the NI assessment with historical borrowing could be treated as a conditional analysis. In this research, we discuss the methods and the associated considerations including sample size calculation and type I error probability control for historical data borrowing for the NI assessment. An example and simulations are used to illustrate the applications and compare the characteristics of the methods.

Speaker biography:
Dr. Hui Quan is currently the global head of the Statistical Research group of the Biostatistics and Programming Department of Sanofi. He received his PhD degree in statistics from Columbia University in 1990. He has 30 years of pharmaceutical industry experience in many therapeutic areas. He has published 108 papers including 84 statistical papers. He is a co-author/co-editor of three books. He has served as associate editor for two journals. He was elected as a fellow of the American Statistical Association in 2008.

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