DIA BSWG KOL lecture series, L05

Event Date:



Speaker: Dr. Samiran Ghosh (Wayne State University School of Medicine, Director of Biostatistics in BERD, Department of Family Medicine and Public Health Sciences, Center for Molecular Medicine and Genetics)

Title: - “Design and Analysis of Non-Inferiority Trials: Some Frequentist and Bayesian Perspective”

Abstract: - Randomized controlled trials (RCT's) are an indispensable source of information about efficacy of treatments in almost any disease area. With the availability of multiple treatment options, comparative effectiveness research (CER) is gaining importance for better and informed health care decisions. However, design and analysis of effectiveness trial is much more complex than the efficacy trial. The effect of including an active comparator arm/s in a RCT is immense. This gives rise to superiority and non-inferiority trials. The non-inferiority (NI) RCT design plays a fundamental role in CER, which will be the primary focus of this talk. Traditional NI trials do not include any placebo arm; however, this comes at a cost of stringent assumptions which must hold for making valid inference via such trial. At the recommendation of EMA a three-arm (including placebo) is often considered provided there is no severe ethical concern. These trials nevertheless require careful attention while constructing NI margin and also the number of hypotheses that can be tested. Selection of appropriate outcome measure and proper functional of those outcomes also plays a vital role. In the past decade many statistical methods have been developed, though largely in the Frequentist setup. However, availability of historical placebo-controlled trial is useful and if integrated in the current NI trial design, can provide better precision for CER. This may reduce sample size burden and improves statistical power significantly in current trial. Bayesian paradigm provides a natural path to integrate historical as well as current trial data via sequential learning in the NI setup. In this talk we will discuss both fraction margin and fixed margin based approach that covers both Frequentist and Bayesian approach for three-arm NI trial. No prior knowledge of NI trial is necessary to understand most of the talk. The current talk has significant contributions from two post-doctoral fellows and FDA scientists at various point of time.

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Starting Time:

11:00 am

Ending Time:

1:00 pm