Clinical trials with steril preparations. Analysis of Spain clinical trial registry

Objective: To review the legal regime for sterile products preparation in the context of clinical trials. Method: A literature review 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 Registry analysis 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 research drugs. All professionals involved in clinical research should be aware of these regulations in order to maintain Spain’s position of excellence in clinical research at the international level.