Only 31 out of the 54 African countries had recorded medical device clinical trials on clinicaltrials.gov. Northern Africa had the highest number of registered MDCTs, with Egypt contributing to the majority at 795 out of 826. However, the other three Northern African countries, Tunisia, Sudan, and Morocco combined, only accounted for 31 out of these MDCTs. Central Africa had the lowest number of recorded MDCTs at just 8 out of the total of 1170, with only Cameroon, the Democratic Republic of Congo, and Chad having any registered MDCTs. In Southern Africa, South Africa led with 116 out of 168, and in Western Africa, Nigeria was leading with 12 out of 34. Most Eastern African countries had recorded clinical trials, with Uganda leading at 47 out of 134, followed by Kenya and Tanzania at 35 and 23, respectively. Burundi had only one registered MDCT, while Comoros, Somalia, Somaliland, Djibouti, and Eritrea did not have any registered medical device clinical trials. Table 1 and Fig. 2 show the detailed analysis of this dataset.

The number of medical device clinical trials carried out in the various African countries

There were a variety of conditions under investigation across the continent as shown in Fig. 3. These MDCTs were focusing on HIV, malaria, tuberculosis, both male and female reproductive conditions, infectious diseases, non-communicable diseases, rehabilitation, and assistive devices among others. Female reproductive health issues and devices for contraception were studied fairly equally across the Eastern, Northern, and Southern regions while almost all other health issues had regional differences in emphasis. We conducted descriptive statistical analyses to explore the distribution and variability of different medical conditions across five regions: Central, Eastern, Northern, Southern, and Western. The analysis involved calculating the mean and standard deviation for each region to quantify the central tendency and dispersion of condition counts. The Northern region exhibited the highest burden of medical conditions, with a mean count of 66.92 cases per condition and a standard deviation of 55.34, indicating a wide variation in the prevalence of different conditions. The Southern region followed with a mean count of 18.00 and a standard deviation of 18.97, suggesting a moderate level of prevalence and variability. The Eastern region had a mean count of 13.50 and a standard deviation of 15.26, while the Western region showed a lower mean count of 2.83 and a standard deviation of 3.86. The Central region had the lowest mean count of 1.25 and a standard deviation of 2.83, indicating the least burden and variability among the regions.

Faceted graph showing the various healthcare challenges being addressed for the various clinical trials reported in clinicaltrials.gov across the different African regions

In the North, most MDCTs were on dental conditions such as cleft palate, dental caries, and pulpitis, male reproductive conditions like erectile dysfunction, and pain management. This region also had more studies on non-communicable diseases, especially diabetes and obesity, and trials on neurodegenerative conditions. MDCTs on prosthetics were only registered in Northern Africa.

Trials on HIV/AIDS, infectious diseases, and circumcision were more concentrated in the Southern and Eastern African countries. Eastern Africa registered more trials on malaria and neonatal health than other regions, while Southern Africa registered more trials on tuberculosis. Most of the trials from Western Africa were on malaria and female reproductive conditions.

All the regions had MDCTs on COVID-19.

Half of all the registered MDCTs (n = 643, 55.3%) had been completed by the time the site was accessed. Despite having fewer studies than other regions, Western and Central Africa had most of their trials completed compared to other regions. A number of MDCTs (n = 204) in all regions except Central Africa were recruiting participants. There were MDCTs that were either active but not recruiting, enrolling by invitation, or not yet recruiting as shown in Fig. 4.

Faceted bar graph showing the status of medical device clinical trials registered on clinicaltrials.gov across the different African regions

A few studies had been suspended, others terminated, and some were withdrawn. A significant number of studies had an unknown status (n = 183, 15.6%). All suspended trials were from Northern Africa.

There were four categories of funders recorded on the clinicaltrials.gov website: the US National Institutes of Health (NIH), other US federal agencies, industry, and all others. There was a variety of collaborations among funders to sponsor MDCTs across the African continent as shown in Fig. 5.

Funders of medical device clinical trials across the different African regions

Seventy-nine trials were funded exclusively by industry, the majority of which were from Southern (n = 60) and Northern (n = 14), and the rest from Eastern Africa (n = 5). Seven MDCTs were funded exclusively by the NIH with Eastern Africa having the majority of these trials (n = 4). Other US federal agencies, for example, the Centers for Disease Control and Prevention, collaborated with industry and other funders and were involved in a total of 12 MDCTs.

The majority of medical device clinical trials were funded exclusively by all other bodies (n = 1024, 87.5%) besides the NIH and US federal agencies. Funding for these MDCTs was through collaborations between universities, hospitals, European institutions like the Medical Research Council (MRC), the European Institute of Oncology, and foundations such as the Bill and Melinda Gates Foundation.

Duration for MDCTs was obtained as the difference between the start year and completion year as recorded for each trial on the website. Trials whose completion year was beyond 2019 were also labeled as COVID affected. The duration of MDCTs was compared between the different regions as shown in the box plot in Fig. 6.

A box plot showing the duration of medical device clinical trials in the various African regions

Southern and Western Africa had a similar median duration of 2 years for MDCTs, which was significantly higher than all other regions. Southern Africa also had the most dispersed distribution which indicated that the duration of MDCTs in this region was much more spread out than other regions. Western and Southern Africa had positively skewed distributions; however, the skew observed in the west was less significant since the median line was in the middle of the box.

Eastern and Northern Africa had a median duration of 1 year. However, this was found close to the lower quartile, which indicates that the mean duration of trials in these regions is greater than the median. Nonetheless, MDCTs in these regions were the least dispersed distribution, with the duration of MDCTs in these regions ranging from 1 to 2 years.

Central Africa had an almost symmetrical distribution despite the negative skew indicated by the median duration closer to the lower quartile. This meant that most of the trials in the region lasted longer than the median duration of approximately 1.5 years. Outliers existed in all regions except Central Africa. Northern Africa had the highest number of outliers, while South Africa had the most significant.

The majority of the devices that were undergoing clinical trials were for treatment purposes (n = 715) and of these oral (n = 121) and skeletal health (n = 72) problems were the majority.

Devices for prevention (n = 201) and diagnostic (n = 144) purposes were also in high number. Among the devices for prevention purposes were those addressing HIV (n = 34), infections (n = 30), female reproductive issues (n = 19), and circumcision (n = 16). Diagnostic devices were mainly addressing conditions such as tuberculosis (n = 21), HIV, malaria, and female reproductive conditions all registering 13 devices.

Other MDCTs were carried out for devices intended for health services research (n = 42), supportive care (n = 54), screening (n = 32), basic science (n = 9), and other purposes (n = 39) as shown in Table 2.

This table presents the proportional distribution of clinical trials across various medical conditions, delineated by their primary purpose. Diagnostic studies constitute the largest segment (37.9%) of trials for infectious diseases, which underscores a significant research focus on identifying these conditions. Conversely, treatment-focused trials predominate the area of non-communicable diseases, accounting for 56.9% of the trials, highlighting a therapeutic orientation in addressing chronic ailments. For conditions specific to female reproductive health, nearly half of the trials (47.0%) are treatment-oriented, whereas preventive studies make up a notable 17.1%, indicating a balanced approach towards managing and averting these conditions. Male reproductive conditions see a similar emphasis on treatment (48.7%) with a substantial portion of trials also dedicated to prevention (43.6%), reflecting a strategic focus on both managing existing conditions and preventing new occurrences. Musculoskeletal conditions are overwhelmingly represented in treatment trials (87.0%), suggesting a clinical response to the impacts of these conditions. Organ-specific trials show a heavy inclination towards treatment (79.8%), potentially due to the critical nature of these diseases. Sepsis and infections are predominantly addressed through prevention (54.2%), which is essential for diseases where early intervention can be life-saving. Neurological conditions have an overwhelming majority of trials in treatment (88.7%), aligning with the urgency of addressing the debilitating effects of these diseases.