Summary We develop a new Bayesian approach of sample size determination (SSD) for the design of non-inferiority clinical trials. We extend the fitting and sampling priors of Wang and Gelfand (2002) to Bayesian SSD with a focus on controlling the type I error and power. Historical data are incorporated via a hierarchical modeling approach as well as the power prior approach of Ibrahim and Chen (2000). Various properties of the proposed Bayesian SSD methodology are examined and a simulation-based computational algorithm is developed. The proposed methodology is applied to the design of a non-inferiority medical device clinical trial with historical data from previous trials.

A single corticosteroid injection can offer short-term pain relief in the conservative management of Morton's neuroma.

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[F]PBR102 and [F]PBR111 have distinct metabolic profiles in rat and non-human primates. Radiometabolites contributed to non-specific binding and confounded in vivo brain analysis of [F]PBR102 in rodents; the impact in primates was less pronounced. Both [F]PBR102 and [F]PBR111 are suitable for PET imaging of TSPO in vivo. In vitro metabolite studies can be used to predict in vivo radioligand metabolism and can assist in the design and development of better radioligands.