Title
Characteristics of oncological clinical trials submitted to the instituto nacional de salud del Peru, 1995-2019
Other title
Características de los ensayos clínicos oncológicos presentados al instituto nacional de salud del Peru, 1995-2019
Date Issued
01 October 2020
Access level
open access
Resource Type
journal article
Publisher(s)
Instituto Nacional de Salud
Abstract
A descriptive observational study was carried out to identify the characteristics of the oncological clinical trials submitted to the Instituto Nacional de Salud del Peru during the period from 1995 to 2019. The information was obtained from the Peruvian Registry of Clinical Trials. We identified 1,996 clinical trials during the studied period, from which 470 were oncological (23.5%); 74.9% of the oncological clinical trials were mainly sponsored by the pharmaceutical industry, 61.9% were phase III and 86.2% were authorized. Regarding those authorized clinical trials, 55.6% were on chemical research products and 35.9% were on therapeutic indication for breast cancer. The most frequent study designs found were: Parallel arm (84.7%), randomized (85.2%) and blinded (51.0%); the most frequently used main endpoint was the objective response rate (46.7%). We conclude that the number of oncological clinical trials has been increasing over the years, often with different characteristics.
Start page
739
End page
745
Volume
37
Issue
4
Language
English
OCDE Knowledge area
Estadísticas, Probabilidad Salud pública, Salud ambiental Oncología
Scopus EID
2-s2.0-85100875271
PubMed ID
Source
Revista Peruana de Medicina Experimental y Salud Publica
ISSN of the container
17264634
Sources of information: Directorio de Producción Científica Scopus