Twenty-two years’ experience registering trials in a low-middle income country: The Peruvian Clinical Trial Registry

• Autores: Alarcon Ruiz, Christoper A., Roque Roque, Joel Sack, Heredia, Paula, Gómez Briceño, Angie Roxana, Quispe, Antonio M.
• Formato: artículo
• Fecha de Publicación: 2019
• Institución: Universidad San Ignacio de Loyola
• Repositorio: USIL-Institucional
• Lenguaje: español
• OAI Identifier: oai:repositorio.usil.edu.pe:20.500.14005/9097
• Enlace del recurso: https://hdl.handle.net/20.500.14005/9097; http://dx.doi.org/10.1111/jebm.12354
• Nivel de acceso: acceso embargado
• Materia: Biomedical research; Clinical trial as topic; Perú

Aim: This study analyzes the quantitative and qualitative evolution of the Peruvian Clinical Trial Registry during the last 22 years. Methods: Following a cross-sectional design, we reviewed all clinical trials registered at the Peruvian Clinical Trial Registry during 1995-2017. We downloaded and extracted all registries on 31 March 2018. We summarized qualitative variables and quantitative variables. Also, we performed trends analysis of the records by year, clinical phase, institutional review board, and children's participation. Results: The Peruvian Clinical Trial Registry recorded 1748 clinical trials during 1995-2017. Considering World Health Organization 20-standard descriptors as the standard, the registry suitably recorded four of them in 1995 and 19 since 2013. There was a meaningful change in the trend of the registries, showing a significant upward registry trend until 2008 and a significant downward registry trend since then. This trend could be influenced by new regulation in clinical trials registry. Several trials had incomplete entries for different studied variables. Most of the clinical trials (82%) included male and female participants, and only 14% included children. Oncological disorders were the diseases most frequently investigated (20%). Most of clinical trials were registered by pharmaceutical companies. A few institutional review boards evaluated most of the clinical trials.