title: A kinetic model for the integrated assessment of safety and efficacy in clinical trials.
abstract: Regulatory agencies, professional societies, and clinical trialists commonly base judgments of treatment benefit on separate assessments of efficacy and safety. When separate assessments were compared with an integrated assessment using a kinetic model of a hypothetical randomized trial of antiplatelet agents in patients with acute coronary syndrome, the former showed treatment A to be superior to treatment B, whereas the latter showed treatment B to be superior to treatment A. In conclusion, comparative judgments regarding the balance between efficacy and safety depend on the model chosen for analysis; kinetic models are particularly suited to the integrated assessment of efficacy and safety relative to regulatory decisions, public policy, guideline development, and clinical care.
authors.affiliation: Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, California; David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California.
authors.forename: George A
authors.initials: GA
authors.lastname: Diamond
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D017202:Myocardial Ischemia / Q000628:therapy*; D009204:Myocardial Revascularization / Q000592:standards*; D017063:Outcome Assessment, Health Care; D018570:Risk Assessment / Q000379:methods*; D014481:United States