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拉丁美洲和加勒比国家的国际临床试验:满足当地卫生需求的研究与开发。

International Clinical Trials in Latin American and Caribbean Countries: Research and Development to Meet Local Health Needs.

作者信息

da Silva Ricardo E, Amato Angélica A, Guilhem Dirce B, de Carvalho Marta R, Novaes Maria R C G

机构信息

Office of Clinical Trials, Brazilian Health Regulatory Agency (Anvisa), Brasília, Brazil.

Health Sciences, University of Brasília, Brasília, Brazil.

出版信息

Front Pharmacol. 2018 Jan 5;8:961. doi: 10.3389/fphar.2017.00961. eCollection 2017.

Abstract

Although international health research involves some benefits for the host countries, such as access to innovative treatments, the research itself may not be aligned with their communities' actual health needs. To map the global landscape of clinical trials run in Latin American and Caribbean countries and discuss the addressing of local health needs in the agenda of international clinical trials. The present study is a cross-sectional overview and used data referent to studies registered between 01/01/2014 and 12/31/2014 in the World Health Organization's (WHO) International Clinical Trials Registry Platform (ICTRP). Non-communicable diseases such as diabetes, cancer, and asthma-studies which were financed mainly by industries-were the conditions investigated most in the region of Latin America and the Caribbean. The neglected diseases, on the other hand, such as Chagas disease, and dengue, made up 1% of the total number of studies. Hospitals and nonprofit nongovernmental organizations prioritize resources for investigating new drugs for neglected diseases, such as Chagas disease and dengue. The international multicenter clinical trials for investigating new drugs are aligned with the health needs of the region of Latin America and the Caribbean, when one considers the burden resulting from the non-communicable diseases in this region. However, the transmissible diseases, such as tuberculosis and AIDS, and the neglected diseases, such as Chagas disease and dengue, which have an important impact on public health in this region, continue to arouse little interest among the institutions which finance the clinical trials.

摘要

尽管国际卫生研究给东道国带来了一些益处,比如获得创新疗法,但研究本身可能与当地社区的实际卫生需求并不契合。为了梳理在拉丁美洲和加勒比国家开展的临床试验的全球格局,并探讨在国际临床试验议程中如何满足当地卫生需求。本研究是一项横断面综述,使用了世界卫生组织(WHO)国际临床试验注册平台(ICTRP)中2014年1月1日至2014年12月31日期间注册研究的相关数据。糖尿病、癌症和哮喘等主要由行业资助的非传染性疾病研究,是拉丁美洲和加勒比地区研究最多的病症。另一方面,恰加斯病和登革热等被忽视的疾病,仅占研究总数的1%。医院和非营利性非政府组织将资源优先用于研究治疗被忽视疾病(如恰加斯病和登革热)的新药。当考虑到该地区非传染性疾病造成的负担时,用于研究新药的国际多中心临床试验与拉丁美洲和加勒比地区的卫生需求是相符的。然而,对该地区公共卫生有重要影响的传染病(如结核病和艾滋病)以及被忽视的疾病(如恰加斯病和登革热),在资助临床试验的机构中仍然很少引起关注。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec77/5760498/c6f17c3c1055/fphar-08-00961-g0001.jpg

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