title: [What can we expect from clinical trials in psychiatry?]
abstract: Clinical trials in psychiatry allow to build the regulatory dossiers for market authorization but also to document the mechanism of action of new drugs, to build pharmacodynamics models, evaluate the treatment effects, propose prognosis, efficacy or tolerability biomarkers and altogether to assess the impact of drugs for patient, caregiver and society. However, clinical trials have shown some limitations. Number of recent dossiers failed to convince the regulators. The clinical and biological heterogeneity of psychiatric disorders, the pharmacokinetic and pharmacodynamics properties of the compounds, the lack of translatable biomarkers possibly explain these difficulties. Several breakthrough options are now available: quantitative system pharmacology analysis of drug effects variability, pharmacometry and pharmacoepidemiology, Big Data analysis, brain modelling. In addition to more classical approaches, these opportunities lead to a paradigm change for clinical trials in psychiatry.
authors.affiliation: Pharmacologie Clinique et Pharmacovigilance, AP-HM, Piici, UMR 7298, Aix-Marseille Université-CNRS, Marseille, France.
authors.forename: A
authors.initials: A
authors.lastname: Marsot
authors.affiliation: Pharmacologie Clinique et Pharmacovigilance, AP-HM, Piici, UMR 7298, Aix-Marseille Université-CNRS, Marseille, France.
authors.forename: Q
authors.initials: Q
authors.lastname: Boucherie
authors.affiliation: Pharmacologie Clinique et Pharmacovigilance, AP-HM, Piici, UMR 7298, Aix-Marseille Université-CNRS, Marseille, France.
authors.forename: F
authors.initials: F
authors.lastname: Kheloufi
authors.affiliation: Pharmacologie Clinique et Pharmacovigilance, AP-HM, Piici, UMR 7298, Aix-Marseille Université-CNRS, Marseille, France.
authors.forename: C
authors.initials: C
authors.lastname: Riff
authors.affiliation: Pharmacologie Clinique et Pharmacovigilance, AP-HM, Piici, UMR 7298, Aix-Marseille Université-CNRS, Marseille, France.
authors.forename: D
authors.initials: D
authors.lastname: Braunstein
authors.affiliation: Pharmacologie Clinique et Pharmacovigilance, AP-HM, Piici, UMR 7298, Aix-Marseille Université-CNRS, Marseille, France.
authors.forename: J
authors.initials: J
authors.lastname: Dupouey
authors.affiliation: Pharmacologie Clinique et Pharmacovigilance, AP-HM, Piici, UMR 7298, Aix-Marseille Université-CNRS, Marseille, France.
authors.forename: R
authors.initials: R
authors.lastname: Guilhaumou
authors.affiliation: Service de Psychiatrie, Hôpital de la Conception, Piici, UMR 7298, Aix-Marseille Université-CNRS, Marseille, France.
authors.forename: X
authors.initials: X
authors.lastname: Zendjidjian
authors.affiliation: Département de Gériatrie, Hôpital Sainte-Marguerite, Piici, UMR 7298, Aix-Marseille Université-CNRS, Marseille, France.
authors.forename: S
authors.initials: S
authors.lastname: Bonin-Guillaume
authors.affiliation: Service de Psychiatrie Adultes, CHU Saint-Étienne, 5 Chemin de la Marendière, 42055 Saint-Étienne cedex 2, France.
authors.forename: E
authors.initials: E
authors.lastname: Fakra
authors.affiliation: Aix-Marseille Université, CNRS, CRMBM UMR 7339, 13385 Marseille, France ; APHM, Hôpitaux de la Timone, Pôle d'imagerie Médicale, CEMEREM, 13005 Marseille, France.
authors.forename: M
authors.initials: M
authors.lastname: Guye
authors.affiliation: Aix-Marseille Université, Institut de Neurosciences des Systèmes, 13385 Marseille, France ; INSERM, UMR_S 1106, 13385 Marseille, France.
authors.forename: V
authors.initials: V
authors.lastname: Jirsa
authors.affiliation: SHU Psychiatrie Adultes, Hôpital Sainte Marguerite, 13274 Marseille, France.
authors.forename: J-M
authors.initials: JM
authors.lastname: Azorin
authors.affiliation: SHU Psychiatrie Adultes, Hôpital Sainte Marguerite, 13274 Marseille, France.
authors.forename: R
authors.initials: R
authors.lastname: Belzeaux
authors.affiliation: SHU Psychiatrie Adultes, Hôpital Sainte Marguerite, 13274 Marseille, France.
authors.forename: M
authors.initials: M
authors.lastname: Adida
authors.affiliation: Pharmacologie Clinique et Pharmacovigilance, AP-HM, Piici, UMR 7298, Aix-Marseille Université-CNRS, Marseille, France.
authors.forename: J
authors.initials: J
authors.lastname: Micallef
authors.affiliation: Pharmacologie Clinique et Pharmacovigilance, AP-HM, Piici, UMR 7298, Aix-Marseille Université-CNRS, Marseille, France. Electronic address: olivier.blin@ap-hm.fr.
authors.forename: O
authors.initials: O
authors.lastname: Blin
mesh_terms: D001921:Brain / Q000473:pathology; D002986:Clinical Trials as Topic / Q000379:methods / Q000458:organization & administration / Q000592:standards; D003198:Computer Simulation; D006801:Humans; D001523:Mental Disorders / Q000453:epidemiology / Q000628:therapy*; D017891:Pharmacoepidemiology; D000071185:Pharmacogenomic Testing / Q000379:methods / Q000639:trends; D011570:Psychiatry / Q000379:methods* / Q000639:trends*; D012107:Research Design / Q000592:standards; D014584:User-Computer Interface
keywords: Cerveau virtuel; Clinical trials; Essais cliniques; Pharmacoepidemiology; Pharmacogenetics; Pharmacogenétique; Pharmacologie quantitative des systèmes; Pharmacoépidémiologie; Quantitative system pharmacologie; Virtual brain