The ability to set realistic expectations of treatment response in patients with overactive bladder (OAB) can have an impact on patient engagement and adherence to study medication. In order to help set treatment expectations for OAB, a Physician Predictive Tool has been developed based on predictive modelling. Models have been developed utilizing data from eight Phase 3 and 4 fesoterodine clinical trials and these models enable the prediction of individual treatment response in subjects with OAB, based on various baseline characteristics. The data utilized and covariates that were hypothesized to influence treatment response are described. The model selection and development process are also outlined, and the final model and some example results utilizing this model are presented. Finally, we discuss the potential benefits and limitations of such a predictive tool.
Contemporary clinical trials. 2016 Sep 26 [Epub ahead of print]
Amanda Darekar, Martin Carlsson, Sheila Quinn, Fady Ntanios, Erin Mangan, Daniel Arumi, David Scholfield
Statistics, Pfizer Ltd., Walton Oaks, Tadworth, UK. Electronic address: ., Statistics, Pfizer Inc., New York, NY, USA., GCTE, Dev Ops, Pfizer Inc., New York, NY, USA., Medical Affairs, Pfizer Inc., New York, NY, USA., Inflammation and Immunology, Regeneron, Inc., Tarrytown, NY, USA., Medical Affairs, Pfizer Europe, Madrid, Spain., Clinical Sciences, Pfizer Ltd., Walton Oaks, Tadworth, UK.