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Africa has considerable advantages and opportunities for trialling investigational medicinal products that, if pharma companies can correctly harness, will turn the continent into a superpower for clinical trials.

Across 54 countries, the continent accounts for approximately 17% of the global population, and the total number of people living there is projected to surpass two billion within the next five years. The population is also considerably diverse ethnically. It also possesses the greatest disease burden in the world at around 25%, which includes serious diseases such as HIV/AIDS, malaria, tuberculosis, acute respiratory infections, and diarrheal diseases, which all have high mortality rates.

Rates of non-communicable diseases such as hypertension, cardiovascular disease, chronic respiratory diseases, diabetes, and cancers are also considered high throughout Africa. Research suggests that sub-Saharan Africa is expected to see one of the largest global increases in mortality rates caused by non-communicable diseases.

These high rates of diseases in largely untapped patient pools, present invaluable opportunities to trial new drugs that can help people living with chronic conditions and battling serious illnesses. Crucially, Africa is projected to have the largest working-age population globally by 2050 and its importance for clinical trials is only predicted to increase in future.

“Africa offers effective, innovative and cost-effective ways to execute clinical trials,” explains Rob van den Bergh, Managing Director of Oximio’s sub-Saharan Africa division, which delivers comprehensive services in clinical trial logistics. “It’s home to the highest genetic diversity of humans on the planet and it’s filled with potential participants who are more and more urbanised and eager to be part of the clinical trials.”

However, Africa currently accounts for a very low percentage of global clinical trials, with estimates putting it at approximately 2.5%. While there is clearly a strong pool of patients, there are obstacles and misconceptions that persist in limiting the number of potential clinical trials across the continent.

“There is a misconception that diseases in the Western world are not prevalent in Africa. This is completely incorrect because we know the medications for all therapeutic indications,” says Zayheda Khan, Chief Commercial Officer at Oximio. “The patients exist in Africa, as do the high-quality infrastructure of clinical trial management that are available in any other country or global region.”

Clinical trials data for Africa

Globally, research has found that 62.2% of patients who take part in clinical trials are from a Caucasian background, which rises further to 84.2% in the US. The average representation of other ethnic groups in the US is very low, with 7.3% being African American, 3.4% Asian, and 2.8% from a Latino background. Therefore, the available patient pool of a majority Black population in Africa represents an invaluable opportunity to develop medical products for patients with unmet clinical needs.

According to GlobalData figures, the worldwide percentage of clinical trials started and completed in Africa between 9 December 2012 and 8 March 2023 was 2.2%. Yet of the 5,071 clinical trials during the period studied, the majority were in Egypt with 2,910. Counting just the clinical trials in sub-Saharan Africa, the amount comes to 1,925 – or 1.45% of the global total. Within sub-Saharan Africa, the most trials were recorded in South Africa with 930. Nigeria was the next highest with 169, followed by 163 in Kenya, and 160 in Uganda.

For therapy areas during the period analysed, infectious diseases had the most trials with 944. Oncology and cardiovascular therapies were relatively low with 132 and 118 trials respectively. For indications such as viral infections topped the list with 445 trials, followed by parasitic diseases with 330, and 259 for HIV/AIDs.

One of the many segments where sub-Saharan Africa could lead the world in clinical trials is therapies for sickle cell diseases, which disproportionately impacts Black people in far higher numbers than other racial groups. Yet in the period analysed, GlobalData recorded just 24 clinical trials for sickle cell diseases in the region. In the US, there were 91 clinical trials for sickle cell therapies in the period studied. As the US often struggles to attract enough African American trial participants, sub-Saharan Africa offers a viable solution to test treatments on a much larger population.

Shrinking patient pools in the rest of the world

Africa also holds a solution to addressing the issue of shrinking populations of patients with noncommunicable diseases in the US and Europe. This is because many patients in these regions already have access to comparable drugs. Consequently, there are relatively small patient pools for non-communicable diseases such as cancer, diabetes, heart disease, and Alzheimer’s. Furthermore, Africa offers a population that is more receptive to taking part in clinical trials.

“You have a drug-naïve population in Africa. They don’t have great access to commercial or prescribed drugs and there’s the affordability issue of those,” says Mark Woolf, Chief Business Development Officer for Oximio. “Therefore, they are open to clinical trials, because of the lack of costs that they have to put towards it. They need to have that assistance of access to clinical trials.”

 

Overcoming challenges with clinical trials in Africa

Africa is made up of 54 countries, which potentially means 54 different sets of, not only rules and regulations for customs and operations, but also how they are interpreted on the ground. For clinical trials, this represents considerable complexity that is typically impractical to manage from outside the continent. Then there are the many different languages spoken and understood across Africa.

Historically, these factors have discouraged sponsors from conducting wider clinical trials in Africa, or just repeatedly using one or two African countries that they are familiar with. However, it is possible to navigate these factors effectively by using local experts.

To address all these issues, Oximio has built a coalition of experts in regulatory and logistics across Africa, often based in the countries themselves, to better understand and adopt more advanced supply chain risk management practices.

“In 80% of the countries, we have a regulatory expert who is familiar with the local Department of Health and Ministry of Health processes,” says van den Bergh. “They handle the import licence application on behalf of all the sponsors or investigators in that country. We have one entity that expedites approvals through regulatory, customs and border control getting it to the site twice as fast.”

Oximio handles the end-to-end supply chain process to mitigate any risk or quality concerns sponsors may have in dealing with multiple parties across several countries and borders.

“We go right to either end: to the patient, to the site and investigator,” adds Khan. “Everything is maintained to the highest quality standards and all shipments inbound and outbound are traceable from source to end destination. So, that’s a huge added potential value to ensure products are delivered on time without any delays and some circumstances cost saving too.”

Ensuring the correct chain of custody for shipments

Clinical trials can only be effective if the drug has followed the correct chain of custody, which is secure in terms of temperature maintenance and handling. This can be particularly challenging in the hot climates and remote locations of Africa for biopharma drugs for example, that need to be kept in strict temperatures not only during transit-time and storage, but also once they reach the trial site to dose patients.

Central to Oximio’s services in sub-Saharan Africa is a top-of-the-range, customs bonded distribution facility in Nairobi, Kenya, which provides state-of-the-art storage and distribution operations – strategically located to serve all areas within sub-Saharan Africa, both to the west and the east. The facility is essential in maintaining the clinical supply chain across all African states, which also offers substantial cost benefits.

“Providing research companies with centralised distribution and procurement and the added value to rapidly move clinical trial material, manage biospecimen transportation, perform re-labelling and so on, will most definitely contribute positively to clinical supply chain outcomes,” comments van den Bergh.

In addition, the time-savings offered by this facility in the clinical supply chain are considerable.

“You’re talking about a regulated environment that manages and controls conditions, can import and export under custom-bonded status, which means that research companies can bring investigational products into the African continent, it can be held there and then moved to other nations across sub-Saharan Africa area rapidly, more cost effective with low risk.“

To learn more about how Oximio is unlocking the clinical trial potential of Africa, download the specially commissioned white paper below.