<< Back to Abstract Listing by Author Board Number: E-04 Title: Statistical Considerations for Non-inferiority Trial Methodology in Regulatory Applications H. J. Hung , S. J. Wang , R. O'Neill , C. Anello , Y. C. Wang , K. Mahjoob , E. Nevius , A. Chakravarty , CDER, FDA, Rockville, MD                     Statistical methodology for design and analysis of non-inferiority trials without a placebo arm has been controversial in evaluation of regulatory applications, though a variety of methods are proposed in literature. Statistical considerations rest heavily on two unverifiable assumptions: 1) constancy assumption that the treatment effect of the selected positive control does not attenuate in the non-inferiority trial as compared to the historical trials, 2) assay sensitivity assumption that the non-inferiority trial can detect a treatment difference if it exists. In this poster presentation, the topics to be discussed are the pros and cons of some frequently proposed statistical methods, non-inferiority margin selection, and scenarios where these methods may have utility from a regulatory perspective. Also to be discussed are the contrast between the non-inferiority study designs with a placebo arm and without a placebo arm Category: E. Innovative Approaches to Design and Evaluation of Clinical Trials