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欧洲与发展中国家临床试验伙伴关系(EDCTP)知识中心:开发一个开放平台,以促进高质量的临床研究。

The European & Developing Countries Clinical Trials Partnership (EDCTP) Knowledge Hub: developing an open platform for facilitating high-quality clinical research.

机构信息

Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, OX3 7FZ, UK.

National TB Control Program, Ministry of Health, Mbabane, Eswatini.

出版信息

Trials. 2022 May 7;23(1):374. doi: 10.1186/s13063-022-06311-y.

Abstract

There is stark global inequity in health research in terms of where studies happen, who leads the research and the ultimate beneficiaries of the results generated. Despite significant efforts made, limited research ideas are conceptualised and implemented in low-resource settings to tackle diseases of poverty, and this is especially true in sub-Saharan Africa. There is strong evidence to show that the barriers to locally led research do not vary largely between disease, study type and location and can be largely solved by addressing these common gaps. The European & Developing Countries Clinical Trials Partnership (EDCTP) was established in 2003 as a European response to the global health crisis caused by the three main poverty-related diseases HIV, tuberculosis and malaria. EDCTP has established a model of long-term sustainable capacity development integrated into clinical trials which addresses this lack of locally led research in sub-Saharan Africa, supporting the development of individual and institutional capacity and research outputs that change the management, prevention and treatment of poverty-related and neglected infectious diseases across Africa. In recognition of emergent data on what the barriers and enablers are to long-term, sustainable capabilities to run studies, EDCTP formed a new collaboration with The Global Health Network (TGHN) in September 2017, with the aim to make a set of cross-cutting tools and resources to support the planning, writing and delivery of high-quality clinical trials available to research staff wherever they are in the world, especially those in low- and middle-income countries (LMICs) via TGHN platform. These new resources developed on the 'EDCTP Knowledge Hub' are those identified in the mixed method study described in this commentary as being key to addressing the gaps that the research community report as the most limiting elements in their ability to design and implement studies. The Knowledge Hub aims to make these tools freely available to any potential health research team in need of support and guidance in designing and running their own studies, particularly in low-resource settings. The purpose is to provide open access to the specific guidance, information and tools these teams cannot otherwise access freely. Ultimately, this will enable them to design and lead their own high-quality studies addressing local priorities with global alignment, generating new data that can change health outcomes in their communities.

摘要

在健康研究方面,全球存在明显的不平等现象,表现在研究发生的地点、谁领导研究以及研究结果的最终受益者。尽管已经做出了重大努力,但在资源匮乏的环境中,针对贫困疾病的概念化和实施的有限研究思路很少,在撒哈拉以南非洲尤其如此。有强有力的证据表明,地方主导研究的障碍在疾病、研究类型和地点之间并没有很大的差异,可以通过解决这些共同的差距来解决。欧洲与发展中国家临床试验伙伴关系(EDCTP)成立于 2003 年,是欧洲对艾滋病毒、结核病和疟疾这三种主要与贫困相关的疾病造成的全球卫生危机的回应。EDCTP 建立了一种长期可持续能力发展的模式,纳入临床试验,以解决撒哈拉以南非洲缺乏地方主导研究的问题,支持个人和机构能力以及研究成果的发展,从而改变非洲与贫困相关和被忽视的传染病的管理、预防和治疗。认识到关于长期可持续能力运行研究的障碍和促进因素的新兴数据,EDCTP 于 2017 年 9 月与全球卫生网络(TGHN)建立了新的合作关系,目的是制定一套跨领域的工具和资源,以便为世界各地的研究人员提供高质量临床试验的规划、编写和交付支持,特别是通过 TGHN 平台为中低收入国家的研究人员提供支持。这些在本评论中描述的混合方法研究中确定的新资源被认为是解决研究界报告的最具限制因素的差距的关键,这些因素是他们设计和实施研究的能力的最具限制因素。知识中心旨在向任何有需要的潜在卫生研究团队免费提供这些工具和资源,以支持和指导他们设计和开展自己的研究,特别是在资源匮乏的环境中。目的是为这些团队无法自由获得的特定指导、信息和工具提供开放获取。最终,这将使他们能够设计和领导自己的高质量研究,解决与全球一致的当地优先事项,生成可以改变他们社区健康结果的新数据。

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