Ensayos clínicos con medicamentos estériles. Análisis del Registro Español de ensayos clínicos / Clinical trials with steril preparations. Analysis of Spain clinical trial registry
Artículo
en Español
| IBECS (España) | ID: ibc-225700
Objetivo:
Analizar el régimen jurídico para la preparación de productos estériles en el contexto de los ensayos clínicos.
Método:
Se ha completado una revisión bibliográfica de diferentes normas, guías e informes de organismos, así como de realizarse un análisis del Registro Español de Ensayos Clínicos (REec) para conocer la tendencia del tipo de ensayos clínicos que se realizan en España.
To review the legal regime for sterile products preparation in the context of clinical trials.
Method:
A literaturereview of different rules, guideliness and reports from different organisms has been completed. Furthermore, an analysis of Spanish Clinical Trials Registry (REec) was performed in order to know the trend of what is the type of clinical trials that are being conducted in Spain.
Results:
at Europe Union there is not a specific regulation about this matter, being a member state responsibiliy to have a local law. In Spain, there is a guideline regarding Good Practices of preparation for drugs on Hospital Pharmacy Services. Spain Clinical Trials Registryanalysis indicates that approximately 50% of studies could requiered that those study drugs to be pre-pared on sterile conditions, and on this group, 79% are international studies.
Conclusions:
Spain has solid regulations on sterile preparation drugs for routine practice and for clinical researchdrugs. All professionals involved in clinical research should be aware of these regulations in order to maintain Spains position of excellence in clinical research at the international level. (AU)