Strategies for developing sustainable health research capacity in low and middle-income countries: a prospective, qualitative study investigating the barriers and enablers to locally led clinical trial conduct in Ethiopia, Cameroon and Sri Lanka
Strategies for developing sustainable health research capacity in low and middle-income countries: a prospective, qualitative study investigating the barriers and enablers to locally led clinical trial conduct in Ethiopia, Cameroon and Sri Lanka
复制标题
DOI：
10.1136/bmjopen-2017-017246
复制
发表时间：
2017-10-01
期刊：
影响因子：
2.9
通讯作者：
Lang, Trudie
中科院分区：
文献类型：
--
作者：
Franzen, Samuel R. P.;Chandler, Clare;Lang, Trudie
2013年，世界卫生组织表示，除非低收入和中等收入国家（LMIC）成为研究的生产者，否则健康目标将难以实现。在建立当地证据库所需的能力中，进行临床试验的能力很重要。对于发展地方主导的审判能力的最佳方式，没有循证指南。本研究旨在确定在LMICs进行本地主导的临床试验的障碍和推动因素，并确定其可持续发展的战略。设计前瞻性，多个案例研究设计，包括访谈（n = 34），焦点小组讨论（n = 13）和过程映射练习（n = 10）。设置案例研究发生在埃塞俄比亚（2011），Cameroon（2012）and Sri Lanka（2013）.Participants通过注册搜索和滚雪球抽样（n = 100）有目的地选择具有临床试验经验的当地卫生研究人员或对试验感兴趣的利益相关者。结果机构和个人在开展试验方面都取得了一定的成功，但在研究系统的各个层面和职能上，障碍和推动因素有很强的共性。可转让的机制进行了总结为必要条件的试验事业，其中包括：认识的研究，动机，知识和技术技能，领导能力，形成合作，包容性的试验业务，政策的相关性和吸收和宏观和体制energization.Conclusions障碍和使能因素，以当地主导的试验事业存在于各级和职能的LMIC研究系统。为促进这一研究创造必要的条件将需要采取多种协调一致的干预措施，力求以系统的方式解决这些问题。讨论中提出的战略为自我维持能力发展办法提供了一个循证框架。这是对文献的重要贡献，将与研究资助者，用户和生产者有关。
Objectives In 2013, the WHO stated that unless low income and middle-income countries (LMICs) become producers of research, health goals would be hard to achieve. Among the capacities required to build a local evidence base, ability to conduct clinical trials is important. There is no evidence-based guidance for the best ways to develop locally led trial capacity. This research aims to identify the barriers and enablers to locally led clinical trial conduct in LMICs and determine strategies for their sustainable development.Design Prospective, multiple case study design consisting of interviews (n = 34), focus group discussions (n = 13) and process mapping exercises (n = 10).Setting Case studies took place in Ethiopia (2011), Cameroon (2012) and Sri Lanka (2013).Participants Local health researchers with previous experiences of clinical trials or stakeholders with an interest in trials were purposively selected through registration searches and snowball sampling (n = 100).Primary and secondary outcome measures Discussion notes and transcripts were analysed using thematic coding analysis. Key themes and mechanisms were identified.Results Institutions and individuals were variably successful at conducting trials, but there were strong commonalities in the barriers and enablers across all levels and functions of the research systems. Transferable mechanisms were summarised into the necessary conditions for trial undertaking, which included: awareness of research, motivation, knowledge and technical skills, leadership capabilities, forming collaborations, inclusive trial operations, policy relevance and uptake and macro and institutional strengthening.Conclusions Barriers and enablers to locally led trial undertaking exist at all levels and functions of LMIC research systems. Establishing the necessary conditions to facilitate this research will require multiple, coordinated interventions that seek to resolve them in a systemic manner. The strategies presented in the discussion provide an evidence-based framework for a self-sustaining capacity development approach. This represents an important contribution to the literature that will be relevant for research funders, users and producers.