TY - JOUR
T1 - Supervisión de ensayos clínicos en hospitales del seguro social de salud del perú
T2 - Enfoque administrativo y regulatorio
AU - García-Mostajo, Jorge A.
AU - Rivera, Fulton P.
AU - Alvarez-Arroyo, Violeta
AU - Catacora-Villasante, Manuel
AU - Acosta, Joshi
N1 - Publisher Copyright:
© 2019, Instituto Nacional de Salud. All rights reserved.
PY - 2019
Y1 - 2019
N2 - 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.
AB - 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.
KW - Clinical Trial
KW - Peru (source: MeSH NLM)
KW - Social Security
UR - http://www.scopus.com/inward/record.url?scp=85078224308&partnerID=8YFLogxK
U2 - 10.17843/rpmesp.2019.364.4569
DO - 10.17843/rpmesp.2019.364.4569
M3 - Artículo
C2 - 31967263
AN - SCOPUS:85078224308
SN - 1726-4634
VL - 36
SP - 687
EP - 691
JO - Revista Peruana de Medicina Experimental y Salud Publica
JF - Revista Peruana de Medicina Experimental y Salud Publica
IS - 4
ER -
