title: [A systemic review of the European Agency for the evaluation of medicinal products (EMEA) recommendations on the conduct of clinical trials in psychiatry].
abstract: OBJECTIVE
  This article critically reviews the European Agency for the Evaluation of Medicinal Products (EMEA) recommendations on the conduct of clinical trials in psychiatry. The EMEA is a regulatory body which provides the institutions of the European Community with the best possible scientific advice on the quality, safety, and efficacy of medicinal products.
  
  
  METHODS
  Systematic review of recommendations, guide-lines and official documents available in the EMEA web site.
  
  
  RESULTS
  Out of nearly 400 documents, we identified 4 documents on the conduct of clinical trials in specific psychiatric disorders and 5 on the use of placebo or active comparator in evaluating a new drug's efficacy and on methodological issues in establishing difference and equivalence of effect. The EMEA recommends clinical trials to detect a difference between the compound under investigation and placebo, and to assess at least non-inferiority against an active comparator. A placebo arm is intended to validate the study. The EMEA supports the use of placebo only when there is no serious risk for the patient. In schizophrenia, depression and bipolar disorder the Agency suggests that a three-arm study is the design of choice, to demonstrate superiority against placebo and a similar balance against an active comparator.
  
  
  CONCLUSIONS
  Despite the many effective therapeutic options available for the pharmacological management of psychiatric disorders, the EMEA regulatory process still relies on the demonstration of efficacy in absolute terms, against a placebo. We discuss this position and put at issue the possibility of developing a new generation of trials to demonstrate superiority of effect of new compounds over reference ones.
authors.affiliation: Istituto di Ricerche Farmacologiche Mario Negri, Milano.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Guaiana
authors.forename: Corrado
authors.initials: C
authors.lastname: Barbui
mesh_terms: D006801:Humans; D018849:Controlled Clinical Trials as Topic; D004358:Drug Therapy / Q000592:standards; D017723:Drug Utilization Review; D017408:Guidelines as Topic; D001523:Mental Disorders / Q000188:drug therapy; D010919:Placebos; D011619:Psychotropic Drugs / Q000627:therapeutic use
chemical_list: D010919:Placebos; D011619:Psychotropic Drugs
vernacular_title: Aspetti regolatori in Europa: revisione sistematica delle raccomandazioni sugli psicofarmaci.