Biomedical Engineering Unit, Department of Physiology, School of Biomedical Sciences, College of Health Sciences, Makerere University, Kampala, Uganda.
Clinical Trials Unit, School of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda.
Trials. 2024 Oct 4;25(1):658. doi: 10.1186/s13063-024-08427-9.
Africa, specifically the Sub-Saharan region, has had numerous medical technology clinical trials to address the various healthcare challenges around infectious diseases, non-communicable diseases, and nutritional disorders it is facing. Medical device clinical trials provide performance data in terms of safety, efficacy, and efficiency, which is a requirement before commercialization. Key players such as academicians, governments, international organizations, and funders collaborate to drive these trials, but their growth in Africa remains slower compared to other parts of the globe. This paper aims to evaluate the number of medical device clinical trials conducted in different African countries that are registered on the clinicaltrials.gov website.
Data on medical device clinical trials was mined from clinicaltrials.gov website accessed on 22nd September, 2022. The data extracted was analyzed and cleaned in Microsoft Excel and R. Countries were grouped into regions and descriptive statistical analyses for each region were done. Additionally, frequency distributions were also generated and no inferential statistical tests were performed, as the primary focus of this analysis was to describe the distribution of medical conditions across regions.
Thirty-one African countries had registered medical device clinical trials on the website with the majority taking place in Egypt and South Africa. Medical device trials for heart related issues took longer to complete compared to other conditions. Malaria, HIV, and male circumcision related device trials were mainly conducted in Eastern and Southern Africa while trials related to dental, fertility, and obesity were concentrated in Northern Africa. Female reproductive health issues were studied equally across all regions. Some African countries did not have any trials registered on clinicaltrials.gov website.
Findings from this study clearly show the disparity in the number, status, and duration of medical device clinical trials across various African countries.
非洲，特别是撒哈拉以南地区，已经进行了许多医学技术临床试验，以应对其在传染病、非传染性疾病和营养障碍方面面临的各种医疗保健挑战。医疗器械临床试验提供了安全性、有效性和效率方面的性能数据，这是商业化之前的要求。学者、政府、国际组织和资助者等主要参与者合作推动这些试验，但与全球其他地区相比，非洲的增长仍然较为缓慢。本文旨在评估在 clinicaltrials.gov 网站上注册的在不同非洲国家进行的医疗器械临床试验的数量。
从 clinicaltrials.gov 网站上挖掘医疗器械临床试验的数据，访问日期为 2022 年 9 月 22 日。提取的数据在 Microsoft Excel 和 R 中进行分析和清理。国家被分为地区，对每个地区进行描述性统计分析。此外，还生成了频率分布，但没有进行推断性统计检验，因为本分析的主要重点是描述不同地区的疾病分布情况。
31 个非洲国家在该网站上注册了医疗器械临床试验，其中大多数试验在埃及和南非进行。与其他疾病相比，心脏相关问题的医疗器械试验完成时间更长。疟疾、艾滋病毒和男性割礼相关的器械试验主要在东非和南非进行，而与牙科、生育和肥胖相关的试验则集中在北非。所有地区都平等地研究了女性生殖健康问题。一些非洲国家在 clinicaltrials.gov 网站上没有注册任何试验。
本研究的结果清楚地显示了不同非洲国家医疗器械临床试验的数量、地位和持续时间存在差异。
