Development of a predictive model for urgency urinary incontinence.
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.
Statistics, Pfizer Ltd., Walton Oaks, Tadworth, UK. Electronic address: Amanda.Darekar@pfizer.com.
Amanda
A
Darekar
Statistics, Pfizer Inc., New York, NY, USA.
Martin
M
Carlsson
GCTE, Dev Ops, Pfizer Inc., New York, NY, USA.
Sheila
S
Quinn
Medical Affairs, Pfizer Inc., New York, NY, USA.
Fady
F
Ntanios
Inflammation and Immunology, Regeneron, Inc., Tarrytown, NY, USA.
Erin
E
Mangan
Medical Affairs, Pfizer Europe, Madrid, Spain.
Daniel
D
Arumi
Clinical Sciences, Pfizer Ltd., Walton Oaks, Tadworth, UK.
David
D
Scholfield
D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D017327:Clinical Trials, Phase IV as Topic; D006801:Humans; D018727:Muscarinic Antagonists / Q000627:therapeutic use*; D018570:Risk Assessment; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D053202:Urinary Incontinence, Urge / Q000209:etiology / Q000503:physiopathology*
D001559:Benzhydryl Compounds; D018727:Muscarinic Antagonists; C526675:fesoterodine
Fesoterodine; Overactive bladder; Predictive model; Treatment response; Urinary urgency incontinence