title: [Compare new therapies with old, not with a placebo: a plea for revision of the Declaration of Helsinki].
abstract: If no therapy is available for a disease and a new therapy may have beneficial effects, a well-designed placebo-controlled randomized trial will not immediately raise ethical questions. Pre-2008 versions of the Helsinki Declaration reflect this. However, the Declaration of 2008 allows placebo-controlled randomized trials even where an established effective therapy is available, providing this is methodologically inevitable and safe for patients. Placebo-controlled trials have important advantages for sponsors: they are easier to perform because fewer patients are required and small improvements are sufficient to show the efficacy of a new therapy. The authors consider both arguments open for interpretation and argue that the current revision of the Declaration of Helsinki should return to its pre-2008 version. They also suggest that, independently of this, IRBs should resume the policy of rejecting protocols that use placebo while withholding an effective treatment.
authors.affiliation: Academisch Medisch Centrum, Amsterdam.
authors.forename: Dick L
authors.initials: DL
authors.lastname: Willems
authors.forename: M Corrette
authors.initials: MC
authors.lastname: Ploem
authors.forename: M Rien
authors.initials: MR
authors.lastname: Vermeulen
mesh_terms: D028744:Ethics Committees, Research; D019317:Evidence-Based Medicine / Q000379:methods*; D006381:Helsinki Declaration; D006801:Humans; D010919:Placebos; D016032:Randomized Controlled Trials as Topic / Q000941:ethics / Q000379:methods
chemical_list: D010919:Placebos