Características de los ensayos clínicos autorizados en el Perú, 1995-2012

Translated title of the contribution: Characteristics of clinical trials authorized in Peru: 1995-2012

Gabriela Minaya, Duilio Fuentes, Cristian Obregón, Beatriz Ayala-Quintanilla, Martín Yagui

Research output: Contribution to journalArticlepeer-review

10 Scopus citations

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.

Translated title of the contributionCharacteristics of clinical trials authorized in Peru: 1995-2012
Original languageSpanish
Pages (from-to)431-436
Number of pages6
JournalRevista Peruana de Medicina de Experimental y Salud Publica
Volume29
Issue number4
DOIs
StatePublished - 2012

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