Abstract

CAHUINA-LOPE, Paula; SOLIS-SANCHEZ, Gilmer  and  ESPIRITU, Nora. Characteristics of oncological clinical trials submitted to the Instituto Nacional de Salud del Peru, 1995-2019. Rev. perú. med. exp. salud publica [online]. 2020, vol.37, n.4, pp.739-745.  Epub Nov 09, 2020. ISSN 1726-4634.  http://dx.doi.org/10.17843/rpmesp.2020.374.5167.

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.

Keywords : Study Characteristics; Neoplasms; Clinical Trial.

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