title: Need for Outcome Scenario Analysis of Clinical Trials in Diabetes.
abstract: Since the FDA requirement for cardiovascular safety of all new antihyperglycemic drugs to enter the market, the number and extent of phase 3 clinical trials has markedly increased. Unexpected trial results imply an enormous economic, personal and time cost and has deleterious effects over R&D. To prevent unforeseen developments in clinical trials, we recommend performing a comprehensive prospective outcome scenario analysis before launching the trial. In this commentary, we discuss the most important factors to take in consideration for prediction of clinical trial outcome scenarios and propose a theoretical model for decision making.
authors.affiliation: 1 Sciarc Institute, Baierbrunn, Germany.
authors.forename: Rosa
authors.initials: R
authors.lastname: Garcia-Verdugo
authors.affiliation: 1 Sciarc Institute, Baierbrunn, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Erbach
authors.affiliation: 1 Sciarc Institute, Baierbrunn, Germany.|2 Forschergruppe Diabetes e.V. at the Helmholtz Center, Munich-Neuherberg, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Schnell
mesh_terms: D017326:Clinical Trials, Phase III as Topic; D003920:Diabetes Mellitus / Q000188:drug therapy*; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects* / Q000493:pharmacokinetics; D010043:Outcome and Process Assessment, Health Care / Q000379:methods*; D012107:Research Design; D016896:Treatment Outcome
chemical_list: D007004:Hypoglycemic Agents
keywords: clinical trials; outcome prediction; scenario analysis