Clinical research conducted to Good Clinical Practice (GCP) standards is increasingly being undertaken in resource-constrained low-income and middle-income countries (LMICs) settings. This presents unique challenges that differ from those faced in high-income country (HIC) contexts, due to a dearth of infrastructure and unique socio-cultural contexts. Field experiences by research teams working in these LMIC contexts are thus critical to advancing knowledge on successful research conduct in these settings. The Medical Research Council Unit The Gambia at London School of Hygiene and Tropical Medicine has operated in The Gambia, a resource-constrained LMIC for over 70 years and has developed numerous research support platforms and systems. The unit was the lead clinical collaborator in a recently completed Expanded Program on Immunization Consortium (EPIC) study, involving a multicountry collaboration across five countries including the USA, Canada, Belgium, Papua New Guinea and The Gambia. The EPIC study recruited and completed follow-up of 720 newborn infants over 2 years. In this paper, we provide in-depth field experience covering challenges faced by the Gambian EPIC team in the conduct of this study. We also detail some reflections on these challenges. Our findings are relevant to the international research community as they highlight practical day-to-day challenges in conducting GCP standard clinical research in resource-constrained LMIC contexts. They also provide insights on how study processes can be adapted early during research planning to mitigate challenges. There are no data in this work.

中文翻译：

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在资源有限的环境中进行临床研究：冈比亚纵向队列研究的经验教训

按照良好临床实践 (GCP) 标准进行的临床研究越来越多地在资源有限的低收入和中等收入国家 (LMIC) 环境中进行。由于缺乏基础设施和独特的社会文化背景，这带来了与高收入国家 (HIC) 所面临的独特挑战不同的挑战。因此，在这些中低收入国家背景下工作的研究团队的现场经验对于提高在这些环境中成功开展研究的知识至关重要。伦敦卫生和热带医学学院冈比亚医学研究委员会单位在冈比亚这个资源有限的中低收入国家运营了 70 多年，并开发了众多研究支持平台和系统。该单位是最近完成的免疫联盟扩展计划 (EPIC) 研究的主要临床合作者，该研究涉及美国、加拿大、比利时、巴布亚新几内亚和冈比亚等五个国家的多国合作。EPIC 研究招募了 720 名新生儿，并完成了为期 2 年的随访。在本文中，我们提供了深入的现场经验，涵盖了冈比亚 EPIC 团队在进行这项研究时所面临的挑战。我们还详细介绍了对这些挑战的一些思考。我们的研究结果与国际研究界相关，因为它们强调了在资源有限的 LMIC 背景下进行 GCP 标准临床研究的实际日常挑战。他们还提供了有关如何在研究规划期间尽早调整研究流程以缓解挑战的见解。这项工作中没有任何数据。