在Côte科特迪瓦、老挝人民民主共和国和奔巴岛开展伊维菌素-阿苯达唑抗毛虱随机对照试验获得的见解。

3区 医学 Q1 Immunology and Microbiology
Advances in Parasitology Pub Date : 2021-01-01 Epub Date: 2020-12-19 DOI:10.1016/bs.apar.2020.11.001
Ladina Keller, Eveline Hürlimann, Chandni Patel, Sophie Welsche, Somphou Sayasone, Said M Ali, Shaali M Ame, Jean Tenena Coulibaly, Jennifer Keiser
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引用次数: 2

摘要

关于在资源有限的医疗环境中进行临床研究时克服挑战的试验方法、试验程序和缓解战略的科学文献有限。组织、文化、基础设施和伦理方面的挑战可能因环境而异,尽管对同一种疾病(在我们的案例中是土壤传播蠕虫(STH)感染)进行临床试验具有类似的实施风险。我们以2018年至2020年期间在Côte科特迪瓦、老挝人民民主共和国和彭巴岛(坦桑尼亚)进行的一项III期随机对照试验为例,分享面临的挑战和缓解策略,以指导未来在类似环境下的研究规划。我们描述了三种情况下的计划、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筹备和实施试验的关键因素。一项适应每种环境的战略计划,明确关注社区参与和劳动力,对于有效进行至关重要。试验人群和试验团队之间的相互信任是至关重要的,可以对新出现的问题做出早期反应和适应。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Insights gained from conducting a randomised controlled trial on Ivermectin-Albendazole against Trichuris trichiura in Côte d'Ivoire, Lao PDR and Pemba Island.

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.

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来源期刊
Advances in Parasitology
Advances in Parasitology 医学-寄生虫学
CiteScore
9.00
自引率
0.00%
发文量
28
审稿时长
>12 weeks
期刊介绍: Advances in Parasitology is recognised as a leading review serial which is consistently well placed in terms of impact factor and citations. Major reviews on all aspects of medical, veterinary and wild-life parasitology are considered. The journal provides an outlet for authoritative reviews from experts in the field. While emphasis is given to modern molecular approaches contributions across all disciplines are encouraged including traditional areas such as ecology and taxonomy. Eclectic volumes are supplemented by thematic volumes dedicated to a particular topic of recognised interest and importance.
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