EC2 ADMINISTRATIVE INTERVENTION ON OBSERVATIONAL STUDIES WITH MEDICINES: A NIGHTMARE WITH NO ADDED VALUE

摘要

Objective: Description of the administrative procedures requested by Health Authorities (HA) and Research Ethics Committees (REC) to perform an observational study with medicines, based on a real example.Setting and Method: We decided to carry out a Spanish muiti-centre prospective observational study that, according to medicines regulations, is considered a post authorisation study (EPA).The study was to be performed in 62 Spanish-hospitals involving 15 different Autonomous-Governments. Health Authorities: The study was submitted to 13 different HA.Results: In a period of 9 months, we obtained 9 favourable opinions and 2 refusals. Prior to get the positive opinion, 6 of the 9HA requested clarifications on the proposed study and 1 formally rejected the study. The 2 HA that refused the study did it without requesting clarifications. We were not given option to answer the objections, which is not the standard administrative procedure in Spain. Research Ethics committees: The study was submitted initiallyto review by 6 REC, all approved the study without requesting major objections. Once the study approved by those REC and the HA we informed the local REC of the involved centres that the study was to be done and that, although there was no payment to participant investigators, an agreement with the centre will be signed according to local regulations. Answers from the 53 REC notified has been disparate. Up to 17 (32%) requested a formal submission of the study to be evaluated, in spite it was an observational study approved by REC and their respective HA and that there was no local regulation requesting their approval. Requisites of these REC were heterogeneous and complex, demanding non-applicable requirements such as a specific insurance or cumbersome number of copies and specific documents. Some REC have changed their opinion after personal phone conversations but most of them insist in that this is a requirement of the hospital manager, as if the role of the REC was to be an advisor to the manager.