Amboka Patrick, Kurui Daniel, Wamukoya Marylene, Sindi Julius Kirimi, Vicente-Crespo Marta
Research and Related Capacity Strengthening Division, African Population and Health Research Center, APHRC, Nairobi, Kenya.
School of Public Health, University of the Witwatersrand, Johannesburg, South Africa.
Front Epidemiol. 2024 Aug 15;4:1417419. doi: 10.3389/fepid.2024.1417419. eCollection 2024.
Global inequality in clinical research capacity and service delivery can be indicated simply by the proportion of clinical trials that a country or region has registered in clinical trial registry databases. The proportion of clinical trials registered in Africa is very low at 0.02%, even though the region accounts for approximately 15% of the world's population. Despite the economic challenges in most African countries, they have shown potential for growth and change in recent years.
We conducted desk reviews on the interventional clinical trials done in Kenya, Ethiopia, and Nigeria between 2015 to May 2023. The search was done in clinical trials repositories, and journal repositories. The search focused on intervention clinical trials. Data was extracted by screening through the publications and clinical trial platforms. The data extracted from the publications included the type of clinical trial, clinical trial phase, diseases, etc. The data extracted from the reports included: challenges in conducting clinical trials, capacity-building efforts, and the impact of the clinical trial.
The number of clinical trial studies identified in Kenya was 113 (28 were on infant clinical trials). The study identified 97 clinical trials in Nigeria, of which 11 studies were on infant clinical trials. In Ethiopia, there were 28 clinical trials and only five were on infant clinical trials. The landscape review also expanded to capacity and gaps in clinical trials in the three countries. The largest proportion of clinical trials carried out in Kenya was on injury, occupational disease, and poisoning, 30.5% ( = 18) and the smallest proportion was on kidney disease, neonatal disease, obstetrics, and gynecology. Most Infant clinical trials were carried out in the area of infections and infestations 33.3% ( = 7). Most of the challenges faced by clinical trials in the three countries include a lack of infrastructure, a lack of human resources, and a lack of financial resources.
There is a need to map clinical trials done by African researchers based in Africa to exclude the trials done by non-African researchers based in Africa. Opportunities for clinical trials should be supported and challenges addressed.
全球临床研究能力和服务提供方面的不平等可以简单地通过一个国家或地区在临床试验注册数据库中注册的临床试验比例来体现。非洲在临床试验注册中的占比非常低,仅为0.02%,尽管该地区约占世界人口的15%。尽管大多数非洲国家面临经济挑战,但近年来它们已展现出增长和变革的潜力。
我们对2015年至2023年5月期间在肯尼亚、埃塞俄比亚和尼日利亚进行的干预性临床试验进行了案头审查。检索在临床试验知识库和期刊知识库中进行。检索重点为干预性临床试验。通过筛选出版物和临床试验平台提取数据。从出版物中提取的数据包括临床试验类型、临床试验阶段、疾病等。从报告中提取的数据包括:开展临床试验面临的挑战、能力建设工作以及临床试验的影响。
在肯尼亚确定的临床试验研究数量为113项(其中28项为婴儿临床试验)。该研究在尼日利亚确定了97项临床试验,其中11项为婴儿临床试验。在埃塞俄比亚,有28项临床试验,其中只有5项为婴儿临床试验。情况综述还扩展到了这三个国家临床试验的能力和差距。在肯尼亚开展的临床试验中,最大比例的是关于损伤、职业病和中毒,占30.5%(即18项),最小比例的是关于肾脏疾病、新生儿疾病、妇产科。大多数婴儿临床试验是在感染和寄生虫病领域开展的,占33.3%(即7项)。这三个国家的临床试验面临的大多数挑战包括缺乏基础设施、缺乏人力资源和缺乏资金。
有必要梳理非洲研究人员在非洲开展的临床试验,以排除非非洲研究人员在非洲开展的试验。应支持临床试验机会并应对挑战。