Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia.
Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia.
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DOI：
10.1136/bmjopen-2013-003616
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发表时间：
2013-11-27
期刊：
影响因子：
2.9
通讯作者：
Lang T
中科院分区：
文献类型：
--
作者：
Franzen SR;Chandler C;Enquselassie F;Siribaddana S;Atashili J;Angus B;Lang T
临床试验为政策提供了“黄金标准”证据，但在低收入和中等收入国家进行的当地相关试验不足。地方制药商发起的试验可以为国家政府提供高度相关的数据，但缺乏如何促进这些数据的信息。我们的目标是确定埃塞俄比亚由检察官发起的审判的障碍和推动因素，以通报和指导能力加强举措。探索性定性研究，包括深入访谈（n=7）和焦点小组讨论（n=3）。2011年3月在埃塞俄比亚开展了实地工作。通过滚雪球抽样（n=20）招募了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。利用专题编码分析对详细的讨论说明进行了分析，并确定了关键专题。所有参与者都认为，制造商发起的试验对于产生当地证据很重要。体制和组织方面的障碍包括：资金分配有限、监管和行政系统薄弱、学习机会少、人力和物力有限以及开展研究的激励措施不足。业务障碍是这些障碍的症状。缺乏进行审判的意识、信心和动机是重要的个人障碍。培训、知识共享和经验交流是开展审判的关键推动因素，各方一致认为，协作对于提高能力十分重要。在个人、操作、组织和系统层面发现了试验开展的障碍。这些研究结果表明，为了增加埃塞俄比亚当地主导的试验，需要在全系统范围内进行改革，以创造一个更容易接受和有利的研究环境。至关重要的是，在潜在的试验组之间建立研究网络，可以通过分享财务和项目管理负担、知识和资源，提供急需的实际合作支持。这些研究结果可能对加强能力的举措产生重要影响，但在更广泛地推广这些结果之前，还需要进一步的研究。
Clinical trials provide ‘gold standard’ evidence for policy, but insufficient locally relevant trials are conducted in low-income and middle-income countries. Local investigator-initiated trials could generate highly relevant data for national governments, but information is lacking on how to facilitate them. We aimed to identify barriers and enablers to investigator-initiated trials in Ethiopia to inform and direct capacity strengthening initiatives. Exploratory, qualitative study comprising of in-depth interviews (n=7) and focus group discussions (n=3). Fieldwork took place in Ethiopia during March 2011. Local health researchers with previous experiences of clinical trials or stakeholders with an interest in trials were recruited through snowball sampling (n=20). Detailed discussion notes were analysed using thematic coding analysis and key themes were identified. All participants perceived investigator-initiated trials as important for generating local evidence. System and organisational barriers included: limited funding allocation, weak regulatory and administrative systems, few learning opportunities, limited human and material capacity and poor incentives for conducting research. Operational hurdles were symptomatic of these barriers. Lack of awareness, confidence and motivation to undertake trials were important individual barriers. Training, knowledge sharing and experience exchange were key enablers to trial conduct and collaboration was unanimously regarded as important for improving capacity. Barriers to trial conduct were found at individual, operational, organisational and system levels. These findings indicate that to increase locally led trial conduct in Ethiopia, system wide changes are needed to create a more receptive and enabling research environment. Crucially, the creation of research networks between potential trial groups could provide much needed practical collaborative support through sharing of financial and project management burdens, knowledge and resources. These findings could have important implications for capacity-strengthening initiatives but further research is needed before the results can be generalised more widely.
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