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从在科特迪瓦、老挝和奔巴岛进行的伊维菌素-阿苯达唑治疗鞭虫随机对照试验中获得的见解。

Insights gained from conducting a randomised controlled trial on Ivermectin-Albendazole against Trichuris trichiura in Côte d'Ivoire, Lao PDR and Pemba Island.

机构信息

Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.

Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland; Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.

出版信息

Adv Parasitol. 2021;111:253-276. doi: 10.1016/bs.apar.2020.11.001. Epub 2020 Dec 19.

Abstract

There is only limited scientific literature on trial methodology, trial procedures and mitigation strategies to overcome challenges faced during clinical research taking place in resource constrained healthcare environments. Organisational, cultural, infrastructural and ethical challenges may vary between settings although conduct of clinical trials for the same disease (in our case soil-transmitted helminth (STH) infections) share similar risks for implementation. We use the example of a phase III randomised controlled trial, conducted between 2018 and 2020 in Côte d'Ivoire, Lao PDR and Pemba Island (Tanzania), to share challenges faced and mitigation strategies to guide future planning of studies in similar settings. We describe the planning, screening, enrolment and implementation phases in each of the three settings. Our findings indicate that involvement of local staff and close collaboration are essential factors for successful trial preparation and implementation. A strategic plan adapted to each setting with a distinct focus on community engagement and workforce is crucial to proceed efficiently. Mutual trust between the trial population and the trial team is of utmost importance and allows for early reaction and adaption to emerging issues.

摘要

关于在资源有限的医疗保健环境中进行临床研究时的试验方法、试验程序和缓解策略的科学文献有限。尽管在同一疾病(在我们的情况下是土壤传播的蠕虫感染)的临床试验具有相似的实施风险,但组织、文化、基础设施和伦理方面的挑战可能因环境而异。我们以 2018 年至 2020 年在科特迪瓦、老挝和奔巴岛(坦桑尼亚)进行的一项 III 期随机对照试验为例,分享所面临的挑战和缓解策略,为在类似环境中规划未来的研究提供指导。我们描述了在每个环境中的规划、筛选、登记和实施阶段。我们的研究结果表明,当地工作人员的参与和密切合作是成功进行试验准备和实施的关键因素。针对社区参与和劳动力制定的战略计划对于高效进行至关重要。试验人群和试验团队之间的相互信任至关重要,可以促进对新出现问题的早期反应和适应。

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