Need for Outcome Scenario Analysis of Clinical Trials in Diabetes. (March 2017)

• Record Type: Journal Article
• Authors: Garcia-Verdugo, Rosa; Erbach, Michael; Schnell, Oliver
• Is Part Of: Journal of diabetes science and technology. Volume 11:Number 2(2017:Mar.)
• Page Start: 327
• Page End: 334
• Publication Date: 2017-03
• Subjects: clinical trials -- outcome prediction -- scenario analysis; Diabetes -- Periodicals; Medical technology -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462005
• DOI: 10.1177/1932296816670925
• Languages: English
• ISSNs: 1932-2968

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.