title: Challenges in designing comparative-effectiveness trials for antidepressants.
abstract: Comparative-effectiveness antidepressant trials offer promise to provide empirical evidence for clinicians choosing among interventions. Whether such trials posit superiority or noninferiority (NI) hypotheses, they pose formidable challenges. For instance, if meaningful antidepressant differences are seen in comparative-superiority trials, they will be small. NI hypothesis testing, on the other hand, requires an a priori NI margin and evidence of trial assay sensitivity. Either design demands unusually large samples, which could render such trials infeasible.
authors.affiliation: Department of Psychiatry, Weill Cornell Medical College, New York, New York, USA. acleon@med.cornell.edu
authors.forename: A C
authors.initials: AC
authors.lastname: Leon
mesh_terms: D000928:Antidepressive Agents / Q000627:therapeutic use*; D057186:Comparative Effectiveness Research / Q000379:methods*; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D018401:Sample Size
chemical_list: D000928:Antidepressive Agents