Características de los ensayos clínicos oncológicos presentados al Instituto Nacional de Salud del Perú, 1995-2019

Paula Cahuina-Lope; Gilmer Solis-Sánchez; Nora Espíritu

doi:10.17843/rpmesp.2020.374.5167

Authors

Paula Cahuina-Lope Instituto Nacional de Salud. Médica cirujana; especialista en Medicina Familiar y Comunitaria http://orcid.org/0000-0002-1259-557X
Gilmer Solis-Sánchez Departamento de Estadística, Demografía, Humanidades y Ciencias Sociales, Facultad de Ciencias y Filosofía, Universidad Peruana Cayetano Heredia. Lima, Perú. cirujano dentista http://orcid.org/0000-0001-7084-088X
Nora Espíritu Instituto Nacional de Salud, Lima, Perú. Médica cirujana. especialista en Pediatría, magíster de Salud Pública http://orcid.org/0000-0002-6340-0285

DOI:

https://doi.org/10.17843/rpmesp.2020.374.5167

Keywords:

Study Characteristics, Neoplasms, Clinical Trial

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 Perú 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.