title: A novel metric to assess the clinical utility of a drug in the presence of efficacy and dropout information.
abstract: The fact that there are high dropout rates in clinical trials of antipsychotic medications raises critical questions regarding the most appropriate method of designing new trials, analyzing efficacy data, and evaluating the clinical utility (CU) of novel treatments. In this article, we consider the use of a model-based approach to define an integrated CU criterion for better characterizing the clinical response to a treatment, for optimizing proof-of-concept trials, and for providing differentiating criteria for novel medications when complete information is not available.
authors.affiliation: Pharmacometrics, GlaxoSmithKline R&D, King of Prussia, Pennsylvania, USA.
authors.forename: N
authors.initials: N
authors.lastname: Goyal
authors.forename: R
authors.initials: R
authors.lastname: Gomeni
mesh_terms: D014150:Antipsychotic Agents / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000379:methods / Q000706:statistics & numerical data*; D055808:Drug Discovery / Q000379:methods / Q000706:statistics & numerical data*; D006801:Humans; D015233:Models, Statistical; D010352:Patient Dropouts / Q000706:statistics & numerical data*; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data*; D012559:Schizophrenia / Q000188:drug therapy
chemical_list: D014150:Antipsychotic Agents