title: A critique of the double-blind clinical trial. Part 1.
abstract: The randomized, double-blind study is generally regarded as the gold standard of clinical drug trials. Bias can occur as a result of the blinding procedure itself, but discussions of this type of bias have been few and far between. This article presents a detailed discussion of such blinding errors, which can obscure genuine drug effects and be of a sufficient magnitude as to generate false-negative results. Uncritical blinding in clinical studies should therefore be questioned.
authors.affiliation: Inno Vision Communications, Aliso Viejo, CA 92656, USA.
authors.forename: H
authors.initials: H
authors.lastname: Kiene
mesh_terms: D015982:Bias; D004311:Double-Blind Method; D005188:False Negative Reactions; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000592:standards*