Title
Supervision of clinical trials in social health insurance at peruvian hospitals: Administrative and regulatory approach
Date Issued
01 January 2019
Access level
open access
Resource Type
journal article
Author(s)
Instituto de Evaluación de Tecnologías en Salud e Investigación
Instituto de Evaluación de Tecnologías en Salud e Investigación
Publisher(s)
Instituto Nacional de Salud
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.
Start page
687
End page
691
Volume
36
Issue
4
Language
Spanish
OCDE Knowledge area
Salud pública, Salud ambiental
Scopus EID
2-s2.0-85078224308
PubMed ID
Source
Revista Peruana de Medicina Experimental y Salud Publica
ISSN of the container
17264634
Sponsor(s)
El presente estudio fue financiado por el Instituto de Evaluación de Tecnologías en Salud e Investigación – IETSI, EsSalud.
Sources of information: Directorio de Producción Científica Scopus