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 he...

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Autor principal: Aguilera,Bernardo
Lenguaje:English
Publicado: Sociedad Médica de Santiago 2021
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Acceso en línea:http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872021000100110
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spelling oai:scielo:S0034-988720210001001102021-05-09Trends in clinical trials performed in ChileAguilera,Bernardo Chile Clinical Trial Ethics, Research 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.info:eu-repo/semantics/openAccessSociedad Médica de SantiagoRevista médica de Chile v.149 n.1 20212021-01-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872021000100110en10.4067/S0034-98872021000100110
institution Scielo Chile
collection Scielo Chile
language English
topic Chile
Clinical Trial
Ethics, Research
spellingShingle Chile
Clinical Trial
Ethics, Research
Aguilera,Bernardo
Trends in clinical trials performed in Chile
description 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.
author Aguilera,Bernardo
author_facet Aguilera,Bernardo
author_sort Aguilera,Bernardo
title Trends in clinical trials performed in Chile
title_short Trends in clinical trials performed in Chile
title_full Trends in clinical trials performed in Chile
title_fullStr Trends in clinical trials performed in Chile
title_full_unstemmed Trends in clinical trials performed in Chile
title_sort trends in clinical trials performed in chile
publisher Sociedad Médica de Santiago
publishDate 2021
url http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872021000100110
work_keys_str_mv AT aguilerabernardo trendsinclinicaltrialsperformedinchile
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