Supervision of clinical trials in social health insurance at peruvian hospitals: administrative and regulatory approach

Authors

  • Jorge A. García-Mostajo Instituto de Evaluación de Tecnologías en Salud e Investigación – IETSI, EsSalud. Lima, Perú. Médico internista, magíster en Salud Pública http://orcid.org/0000-0002-8073-0008
  • Fulton P. Rivera Instituto de Evaluación de Tecnologías en Salud e Investigación – IETSI, EsSalud. Lima, Perú. Universidad Científica del Sur. Lima, Perú. tecnólogo médico, magíster en Microbiología http://orcid.org/0000-0002-3676-389X
  • Violeta Álvarez-Arroyo Instituto de Evaluación de Tecnologías en Salud e Investigación – IETSI, EsSalud. Lima, Perú. médico cirujano
  • Manuel Catacora-Villasante Instituto de Evaluación de Tecnologías en Salud e Investigación – IETSI, EsSalud. Lima, Perú. Universidad Nacional Mayor de San Marcos. Lima, Perú. médico psiquiatra
  • Joshi Acosta Instituto de Evaluación de Tecnologías en Salud e Investigación – IETSI, EsSalud. Lima, Perú. médico especialista en Microbiología y Parasitología, doctora en Microbiología Clínica http://orcid.org/0000-0001-5745-3383

DOI:

https://doi.org/10.17843/rpmesp.2019.364.4569

Keywords:

Clinical Trial, Social Security, Peru

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.

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Published

2019-12-03

Issue

Section

Brief Report

How to Cite

1.
García-Mostajo JA, Rivera FP, Álvarez-Arroyo V, Catacora-Villasante M, Acosta J. Supervision of clinical trials in social health insurance at peruvian hospitals: administrative and regulatory approach. Rev Peru Med Exp Salud Publica [Internet]. 2019 Dec. 3 [cited 2024 Apr. 21];36(4):687-91. Available from: https://rpmesp.ins.gob.pe/index.php/rpmesp/article/view/4569

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