Trends in clinical trials performed in Chile.

Abstract

BACKGROUND\nAn increasingly large proportion of clinical trials is being conducted at non-traditional geographic regions such as Latin America. However, concerns have been raised that hosting countries may lack adequate research regulations and that clinical trials may not address local health needs. In this context, Chile has been hosting a relatively large proportion of clinical trials and has introduced new regulatory protections.\n\n\nAIM\nTo study trends and characteristics of clinical trials in Chile, including the effects of regulatory protections and whether clinical trials are aligned with the local burden of diseases.\n\n\nMATERIAL AND METHODS\nData from clinical trials on pharmaceutical products registered over the last decade in Chile s Institute of Public Health was reviewed. Clinical trials were analyzed according to sponsorship, phase, disease studied, and whether distribution of trials according to diseases was aligned with the local burden of diseases measured in disability-adjusted life years.\n\n\nRESULTS\nMost of the 876 clinical trials analyzed were funded by external pharmaceutical companies and corresponded to late-phase trials. The most commonly studied disease groups were neoplasms, musculoskeletal disorders, other noncommunicable diseases, chronic respiratory diseases, diabetes and kidney diseases, neurological disorders, and circulatory diseases. The distribution of clinical trials was partially aligned with the distribution of major causes of disease burden. The introduction of new regulatory protections was followed by changes in the number of trials studying certain disease groups associated with a high burden.\n\n\nCONCLUSIONS\nClinical trials conducted in Chile over the last decade are largely funded by external pharmaceutical companies. Their distribution is partially aligned with local disease burden. The introduction of regulatory protections was followed by changes in the distribution of diseases studied.