Conducting clinical research in a resource-constrained setting: lessons from a longitudinal cohort study in The Gambia.
Conducting clinical research in a resource-constrained setting: lessons from a longitudinal cohort study in The Gambia.
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在资源受限的环境中进行临床研究：冈比亚纵向队列研究的教训。
DOI：
10.1136/bmjgh-2021-006419
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发表时间：
2021-08
影响因子：
8.1
通讯作者：
Idoko OT
中科院分区：
文献类型：
--
作者：
Imam A;Wariri O;Dibbasey T;Camara A;Mendy A;Sanyang AN;Ceesay M;Jallow S;Jallow AE;Bah K;Johnson N;Trawally E;Sowe D;Darboe A;Kampmann B;Idoko OT
在资源有限的低收入和中等收入国家（LMIC）环境中，越来越多地开展符合药物临床试验质量管理规范（GCP）标准的临床研究。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不同的独特挑战。因此，在这些LMIC背景下工作的研究团队的实地经验对于促进在这些环境中成功开展研究的知识至关重要。医学研究理事会单位冈比亚卫生和热带医学伦敦学校在冈比亚，资源有限的低收入国家超过70年，并已开发了许多研究支持平台和系统。该单位是最近完成的扩大免疫联盟计划（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2年以上的随访。在本文中，我们提供了深入的实地经验，涵盖冈比亚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，因为它们突出了在资源受限的LMIC环境中进行GCP标准临床研究的实际日常挑战。他们还提供了关于如何在研究规划早期调整研究过程以减轻挑战的见解。
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.
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影响因子：
5.5
作者：
Miyahara R;Jasseh M;Gomez P;Shimakawa Y;Greenwood B;Keita K;Ceesay S;D'Alessandro U;Roca A
通讯作者：
Roca A
影响因子：
6.4
作者：
Carter, Rosalind J.;Senesi, Reynold G. B.;Luman, Elizabeth T.
通讯作者：
Luman, Elizabeth T.
影响因子：
2.6
作者：
Idoko, Olubukola T.;Smolen, Kinga K.;Kampmann, Beate
通讯作者：
Kampmann, Beate
影响因子：
6.4
作者：
Carter, Rosalind J.;Idriss, Ayesha;Seward, Jane F.
通讯作者：
Seward, Jane F.
影响因子：
4.5
作者：
Kingori, Patricia;Muchimba, Maureen;Kelly, Paul
通讯作者：
Kelly, Paul