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

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. Conclusion: The registration of clinical trials in Peru has improved quantitatively and qualitatively since it started, but its quantitative grow stopped in 2008. Since then, the number of registries has declined steadily. There is an influence of pharmaceutical companies in clinical trial registration.