A compound analysis of medical device clinical trials registered in Africa on clinicaltrials.gov

Brian Matovu, Mercy Takuwa, Charles Norman Mpaata, Noah Kiwanuka, Julius Mugaga, Racheal Patricia Nalwoga, Success Kamuhanda, Paula Kworekwa, Benedict Mulindwa, George William Jjuuko, Maria Klara Wolters, Marc P. Y. Desmulliez, Robert T. Ssekitoleko*

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

Abstract / Description of output

BACKGROUND: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSION: Findings from this study clearly show the disparity in the number, status, and duration of medical device clinical trials across various African countries.
Original languageEnglish
Article number658
Pages (from-to)1-12
Number of pages12
JournalTrials
Volume25
DOIs
Publication statusPublished - 4 Oct 2024

Keywords / Materials (for Non-textual outputs)

  • medical devices
  • clinical trials
  • medical innovations
  • medical device regulations
  • investigational medical devices
  • health technology assessment

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