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Challenges in Designing Comparative‐Effectiveness Trials for Antidepressants
Author(s) -
Leon A C
Publication year - 2012
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2011.208
Subject(s) - clinical trial , comparative effectiveness research , antidepressant , clinical pharmacology , margin (machine learning) , psychological intervention , medicine , clinical study design , alternative medicine , intensive care medicine , psychology , pharmacology , computer science , psychiatry , machine learning , anxiety , pathology
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. Clinical Pharmacology & Therapeutics (2012); 91 2, 165–167. doi: 10.1038/clpt.2011.208