Abstract

GARCIA-MOSTAJO, Jorge A et al. Supervision of clinical trials in social health insurance at peruvian hospitals: administrative and regulatory approach. Rev. perú. med. exp. salud publica [online]. 2019, vol.36, n.4, pp.687-691. ISSN 1726-4634.  http://dx.doi.org/10.17843/rpmesp.2019.364.4569.

The objective of the study was to describe the characteristics of the Clinical Trials (CT) supervised by the Institute of Health Technology Assessment and Research carried out in EsSalud between 2015 and 2018 and the main observations of the supervisions completed. A descriptive study of 82 supervised clinical trials was conducted between 2015 and 2018. Most of the clinical trials were phase III studies (81.7%); the most frequent route of administration of the study products was oral (47.6%), and most were sponsored by the pharmaceutical industry (96.3%). The most frequent observations were those related to the study contract (83.8%), overhead payment (57.3%), and the lack of regulatory documents (47.6%). These findings allow the identification of opportunities for improvement in research regulation and management.

Keywords : Clinical Trial; Social Security; Peru.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )