Supervisión de ensayos clínicos en hospitales del seguro social de salud del perú: Enfoque administrativo y regulatorio

Translated title of the contribution: Supervision of clinical trials in social health insurance at peruvian hospitals: Administrative and regulatory approach

Jorge A. García-Mostajo, Fulton P. Rivera, Violeta Alvarez-Arroyo, Manuel Catacora-Villasante, Joshi Acosta

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Translated title of the contributionSupervision of clinical trials in social health insurance at peruvian hospitals: Administrative and regulatory approach
Original languageSpanish
Pages (from-to)687-691
Number of pages5
JournalRevista Peruana de Medicina de Experimental y Salud Publica
Volume36
Issue number4
DOIs
StatePublished - 2019

Bibliographical note

Funding Information:
El presente estudio fue financiado por el Instituto de Evaluaci?n de Tecnolog?as en Salud e Investigaci?n ? IETSI, EsSalud.

Publisher Copyright:
© 2019, Instituto Nacional de Salud. All rights reserved.

Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.

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