Mbo Florent, Mutombo Wilfried, Ngolo Digas, Kabangu Patrice, Valverde Mordt Olaf, Wourgaft Nathalie Strub, Mwamba Erick
HAT Platform, Drugs for Neglected Diseases initiative, Avenue Milambo, N 4, Quartier Socimat, Gombe, Kinshasa 7948, Democratic Republic of Congo.
Le Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine (PNLTHA), croisement du Boulevard Triomphal avec l'avenue de la Libération, Commune de Kasa-Vubu, Kinshasa 7948, Democratic Republic of Congo.
Trop Med Infect Dis. 2020 Mar 29;5(2):48. doi: 10.3390/tropicalmed5020048.
Clinical research on neglected tropical diseases is a challenge in low-resource countries, and the contribution of clinical and operational research to health system strengthening is poorly documented. Developing new, simple, safe, and effective treatments may improve the effectiveness of health systems, and conducting research directly in health structures may have an additional impact. This study describes the process of conducting clinical trials in the Democratic Republic of Congo (DRC) in compliance with international standards, and the role of the trials in strengthening health system functions, including governance, human resources, health information, provision of care, and the equipping of health services with the necessary supplies and infrastructure. We conclude that conducting clinical trials in endemic areas has not only reinforced and supported the aim of conducting high-level clinical research in endemic countries, but has also brought lasting benefits to researchers, staff, and hospitals, as well as to broader health systems, which have positive knock-on effect on patients outside of the clinical trials and their communities. Sustainability, however, remains a challenge in an underfunded health system, especially with respect to specialized equipment. Clinical research in most of sub-Saharan Africa is highly dependent on international input and external technical support; there are areas of weaknesses in trial design and documentation, as well as in data management and analysis. Financing remains a critical issue, as African investigators have difficulties in directly accessing sources of international research funding.
在资源匮乏的国家开展被忽视热带病的临床研究是一项挑战，临床与运营研究对卫生系统强化的贡献鲜有文献记载。开发新的、简单、安全且有效的治疗方法可能会提高卫生系统的效能，而直接在卫生机构开展研究可能会产生额外影响。本研究描述了在刚果民主共和国按照国际标准开展临床试验的过程，以及这些试验在强化卫生系统功能方面所起的作用，包括治理、人力资源、卫生信息、医疗服务提供，以及为卫生服务配备必要的物资和基础设施。我们得出结论，在流行地区开展临床试验不仅强化并支持了在流行国家开展高水平临床研究的目标，还为研究人员、工作人员和医院以及更广泛的卫生系统带来了持久益处，这对临床试验之外的患者及其社区产生了积极的连锁反应。然而，在资金不足的卫生系统中，可持续性仍然是一项挑战，尤其是在专业设备方面。撒哈拉以南非洲大部分地区的临床研究高度依赖国际投入和外部技术支持；在试验设计与记录以及数据管理与分析方面存在薄弱环节。资金问题仍然至关重要，因为非洲研究人员在直接获取国际研究资金来源方面存在困难。
