Title
Characteristics of clinical trials authorized in Peru: 1995-2012
Date Issued
01 January 2012
Access level
open access
Resource Type
journal article
Author(s)
Organización de las Naciones Unidas para la Educación, la Ciencia y la Cultura
Publisher(s)
Instituto Nacional de Salud
Abstract
Objective. To identify main characteristics of clinical trials (CT) authorized by the National Institute of Health (INS) of Peru from 1995 to August 2012. Material and methods. Cross-sectional study, which reviewed all records of CT submitted for review and possible approval by INS, whose data are part of the Peruvian Registry of Clinical Trials. We performed a descriptive analysis of the states of the CT approval and other characteristics.Results. 1475 clinical trials were assessed, of which 1255 (85.1%) were authorized. From 1 clinical trial officially registered in 1995, its quantity increased to 176 trials submitted in 2008, and then, declined to 128 in 2011. Among the approved CT, 64.1% was in Phase III. Oncology (22.4%), infectious diseases (15.5%) and endocrinology (12.7%) were the most studied specialties and a only 1.2% were for neglected tropical diseases. The oral hypoglycemic drugs, systemic antiviral and antineoplastic agents were the most studied investigational products. The transnational pharmaceutical industry was the main sponsor (87.1%) and executors (62.3%) of clinical trials were mostly in Lima. Conclusions. Clinical trials in Peru mainly focus on noncommunicable diseases and phase III studies. The pharmaceutical industry is the main sponsor. A very small number of authorized clinical trials in Peru were for neglected tropical diseases that shows little attention to the health problems in vulnerable populations.
Start page
431
End page
436
Volume
29
Issue
4
Language
English
OCDE Knowledge area
Ciencias socio biomédicas (planificación familiar, salud sexual, efectos políticos y sociales de la investigación biomédica)
Subjects
Scopus EID
2-s2.0-84873926539
Source
Revista Peruana de Medicina Experimental y Salud Publica
ISSN of the container
17264634
Sources of information:
Directorio de Producción Científica
Scopus