title: [Ethical and methodological quality of non-interventional post-authorization studies promoted by Hospital Pharmacy Departments].
abstract: OBJECTIVE
  To describe the ethical and methodological quality of non-interventional post-authorization studies promoted by Hospital Pharmacy Departments (HPD).
  
  
  METHODS
  HPD promoted studies in the 2009-2011 period included in the Spanish Agency of Medicines and Medical Devices (AEMPS) registry and/or published in "Farmacia Hospitalaria" were identified. The most relevant ethical and methodological characteristics were analyzed. Studies promoted by HPD were also compared with studies not promoted by HPD.
  
  
  RESULTS
  Twenty two studies promoted by HPD, and registered in the AEMPS were identified. Within the registered studies HPD promoted studies had lower sample size estimation (41,5% vs 80%) and international scope (0% vs 24%) compared to non HPD promoted studies with significant differences (p < 0,05). None of the published studies in the journal Farmacia Hospitalaria have been registered in the AEMPS and had lower methodological quality than the registered studies promoted by HPD in characteristics such as presence of control group (3,8% vs 27,3%) (p = 0,0072) and the sample size estimation of (19,2% vs 42,8%) (p < 0,05).
  
  
  CONCLUSIONS
  The management and the methodological and ethical characteristics of the studies promoted by HPD should be improved according to the regulation. The registration in the AEMPS might have a positive impact on the quality of these research protocols.
authors.affiliation: Agencia Española de Medicamentos y Productos Sanitarios. Ministerio de Sanidad, Servicios Sociales e igualdad. Madrid.
authors.forename: D
authors.initials: D
authors.lastname: González Bermejo
authors.forename: M P
authors.initials: MP
authors.lastname: Vicente Sánchez
authors.forename: C
authors.initials: C
authors.lastname: Pozuelo González
authors.forename: D
authors.initials: D
authors.lastname: Macías Saint-Gerons
authors.forename: V
authors.initials: V
authors.lastname: Greciano Greciano
authors.forename: C
authors.initials: C
authors.lastname: de la Fuente Honrubia
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D032984:Ethics, Research; D010607:Pharmacy Service, Hospital / Q000941:ethics* / Q000458:organization & administration; D012042:Registries; D012107:Research Design; D018401:Sample Size; D013030:Spain