Head to head comparisons as an alternative to placebo-controlled trials.
Head to head trials have been proposed as an alternative to the ethical and methodological concerns related to placebo-controlled trials. While those studies may be particularly informative from the clinical and cost-effectiveness point-of-view, avoiding placebo poses several regulatory concerns: for superiority designs, the choice of the trial population, outcomes, dose and escalation of the comparator, as well as the comparator itself may be an issue; for non-inferiority studies, issues related to uncertain assay sensitivity and exposure of large samples to potentially ineffective or unsafe drugs make them inappropriate, in the absence of a previous positive superiority trial, for regulatory purposes. The inclusion of active comparators in regulatory trials should not be seen as an alternative, but as a useful complement to the information that can be obtained from placebo-controlled studies.
Institute of Neuroscience, Hospital Clinic, University of Barcelona, IDIBAPS, CIBERSAM, Villarroel 170, Barcelona 08036, Catalonia, Spain. evieta@clinic.ub.es
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D018849:Controlled Clinical Trials as Topic / Q000191:economics / Q000941:ethics / Q000379:methods*; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy / Q000378:metabolism / Q000523:psychology; D010919:Placebos; D011600:Psychopharmacology / Q000191:economics / Q000941:ethics / Q000379:methods*; D011619:Psychotropic Drugs / Q000493:pharmacokinetics / Q000627:therapeutic use; D013810:Therapeutic Equivalency
D010919:Placebos; D011619:Psychotropic Drugs