Trends in clinical trials performed in Chile

Abstract

Background: An 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. Aim: To 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. Material and Methods: Data 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. Results: Most 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. Conclusions: Clinical 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.

Randomized controlled trials in nursing conducted by Latin American research teams: A scoping review

“…Our findings revealed an average of approximately three RCTs published per year, lower than that reported for Spanish authors which were seven RCTs per year (Medina‐Aedo et al., 2022) and other disciplines and in high‐income countries (Arevalo‐Rodriguez et al., 2018; Gonella et al., 2019; Turrillas et al., 2017). This finding may be explained by political environments, implementation costs, inadequate research training, and poor infrastructure, all of which may disproportionately affect nurses (Aguilera, 2021; Gyawali et al., 2020; Iribarren et al., 2018). It is encouraging to note that the publication of nursing RCTs by Latin American authors, has reached a peak in recent years, consistent with the overall trend of increasing of RCTs publication (Baldi et al., 2014; Vinkers et al., 2021).…”

Caracterización de protocolos de ensayos clínicos de productos farmacéuticos radicados para evaluación regulatoria en Colombia: consideraciones bioéticas y metodológicas

“…Así mismo, se destacan también las investigaciones en infectología y trastornos musculoesqueléticos, estos últimos principalmente representados por condiciones reumatológicas. Por lo tanto, a nivel general los hallazgos están en línea con lo publicado previamente por otros autores en el contexto latinoamericano para países como Perú, Chile y Argentina [7][8][9] . Sin embargo, es notable la baja proporción de trastornos endocrinos, respiratorios y cardíacos observada en la muestra de protocolos, lo cual podría indicar una disminución de propensión hacia estas categorías frente a los resultados de Carreño y de Molina et al, en los cuales dichas áreas terapéuticas eran preponderantes en los ensayos clínicos en Colombia 13,14 .…”

“…Al indagar las características del diseño metodológico de los ensayos clínicos, es posible evidenciar que en Colombia predominan ampliamente los protocolos de fase III aleatorizados, de dos grupos paralelos, doble ciego y controlados con placebo, lo cual es propio de los estudios pivotales que sustentan las solicitudes de autorización de nuevos medicamentos ante agencias regulatorias. Esto coincide con los hallazgos previos en Colombia y otros países latinoamericanos, donde dicho perfil era el más común para los estudios [7][8][9][10] . Así mismo, el número global de sujetos a enrolar en dichos protocolos es alto, lo que da cuenta que principalmente se radican estudios de confirmación terapéutica por encima de aquellos de fases exploratorias o de prueba de concepto que implican un menor tamaño de muestra.…”

“…Sin embargo, en las últimas décadas la investigación clínica se ha extendido a otras regiones emergentes como Asia, África y Latinoamérica, debido a condiciones más favorables para el reclutamiento de sujetos y la reducción de costos 6 . Específicamente en Latinoamérica han aumentado progresivamente el número de estudios en países como Chile, Argentina, Perú y Colombia [7][8][9][10] .…”

Mapping Chilean clinical research: a protocol for a scoping review and multiple evidence gap maps

“…The lack of a prioritised agenda in developing countries may generate a source of inequity, by letting third-party interests (ie, global research funding, or the pharmaceutical industry from high-income countries) inhabit regional research planning,21–23 in a context of poor governance in this matter 12 24. The strategic planning of state funding allocation in most countries can still improve the identification of local evidence gaps to be filled by new research, avoiding (and not funding) redundant research.…”