Background:

Postauthorisation observational studies are crucial source of information on drug effectiveness and safety. The objectives of this work were to describe the characteristics of the postauthorisation observational prospective studies (EPA-SP) for which authorisation was requested in the Valencian region, as well as to explore which factors influenced the aforementioned authorisation.

Methods:

We performed a retrospective analytical study comprising all the EPA-SP for which authorisation was requested in the Valencian region between 2010 and 2015.The variables associated to the studies (e.g., objectives, studied drug, target disease) as well as those concerning the authorisation process itself (e.g., authorisation status, reason for authorisation refusal, current status of the study) were obtained from relevant databases. The analysis was divided into descriptive and analytical stages.

Results:

We included a total of 249 studies, out of which 192 (77,1%) aimed at estimating effectiveness or quality of life. The most frequent types of drugs involved in the studies were the antineoplastic and immunomodulating agents (42%). Only 57% of the studies were granted authorisation, with prescription induction and unusual practice being the most common causes for refusal (40.1% and 39.3%, respectively). The authorisation was linked to the diagnosis (circulatory system OR 10,7, IC95% 2,3 to 49,1), ATC L group (OR 4,2, IC95% 1,9 to 49,1) as well as to whether it had been advocated by the industry (OR 0,5, IC95% 0,3 to 0,9).

Conclusion:

Given the importance of having information on effectiveness and safety in usual practice, it is a priority for EPA-SP to be directed towards these aims and to promote independent research.

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