Whilst not typically considered for the shortlist for previous trials, Africa is an emergent continent based on its size, demographics, level of economic growth and commitment to improving healthcare and life expectancy.
Presently, the population of the African continent is made up of over 1.34 billion people and it is anticipated this will rise to at least two billion people by 2038 and 2.5 billion by 2050.
Making up over 17% of the global population, with a diverse population and bearing the greatest disease burden in the world (at around 25%), the African continent can provide many of the conditions optimal for carrying out clinical trials.
Notably, multiple diseases – specifically those defined as tropical and neglected – are endemic to the developing world, which includes Africa. In spite of the clinical advantages, Africa contributes to less than 2% of the total number of clinical trials.
Africa displays an incredible amount of genetic diversity
The limited presence of African countries in clinical trials is not unusual. Poor visibility of existing sites, confined infrastructure, misunderstandings of requirements to work in the region, cultural barriers and unpredictable clinical trial regulatory timelines are some of the main factors impeding any investment in this area. It is, therefore, considered a burden to conduct clinical trials within Africa.
The virtual absence of Africa from the clinical trials map presents a significant problem. As the continent presents an enormous amount of genetic diversity, if it is not well represented in clinical trials, the trial findings cannot be universal to large populations.
Genetic analyses have clearly shown that ethnic groups show variable results to different treatments, so it is vital to carry out clinical trials in Africa, as Africa endures diseases linked to poverty more than any other continent, and the interventions typically used to treat or cure the diseases of which Africans suffer are developed elsewhere.
Cerba Research firmly believes that Africa provides a significant opportunity for pharmaceutical and biotech companies, as well as nongovernmental organizations seeking out low-cost study sites, low risk of litigation and a diverse participant population.
The latter makes Africa a prime location for research, as the diseases of affluence and poverty are widespread. Moreover, most of the potential patients for enrollment in clinical trials have not received any previous treatment for their diseases – either because they cannot afford it, or it is not available – meaning patient recruitment is easier.
Challenges of running clinical trials in Africa: Are they really a challenge?
Good clinical trial infrastructure in the region
There is ongoing investment and growth in the scientific base across the African continent, which is actively encouraged by local authorities. There are centralized healthcare institutions, highly motivated, well-qualified and experienced investigators and superb clinical trial facilities, which can be held up against the best in class all over the world.
From a laboratory perspective, most of the tests are conducted overseas in central labs, when there is, in fact, the capacity to have the central lab work done in some of the local countries. Preferably, central lab hubs placed strategically across Africa can help science progress and boost the knowledge pool around diseases.
Efficient regulatory and ethics committee processes
The processes for regulatory approval in the majority of African countries is no more complex than in Europe or the US. Several countries in Africa have been addressing the need to establish or evolve regulatory infrastructures when faced with a sudden influx of clinical trials.
For the first time, a number of emerging markets are developing these new regulations while many are adopting the US or European standards in a shift towards global alignment.
For a product to be registered, it necessitates approval from the WHO; thus, EMA registration of products is key. As such, each African country has a regulatory board, some more advanced than others, including SAPHRA in South Africa, NAFDAC in Nigeria, and TFDA in Tanzania.
ICH/GCP the only standard
African countries are following or have already incorporated the ICH/GCP guidelines in the approval process for the regulatory and ethics committee.
Clinical trials are being performed in line with the requisite standard operating procedures to guide and train all staff locally, making sure operations are conducted in compliance with ICH/GCP regulations and to meet sponsor requests and requirements.
Faster participant recruitment
There is a large naïve population with diseases of both the developed and developing world, which presents a significant opportunity for rapid, large-scale participant recruitment.
Most trials running in Africa are being funded by NGOs/governments. Including general investigator sites in Africa will help reduce the drug development timelines overall, with an increased number of participants across fewer sites.
This expedited participant recruitment means fewer sites and regulatory applications are needed equating to a reduction in the cost of the study.
As challenging as it may seem, Africa offers a unique profile that is of interest to NGOs and governmental organizations and should be of equal interest to a number of pharmaceutical and biotech companies.
Shifting requirements, larger sample sizes in clinical trials and the need for participant diversity in parallel with enhanced clinical research environments in African countries are resulting in a sizeable growth in clinical research across the region.
There’s more than TB and HIV
Until recently, clinical research has mainly focused on infectious diseases, specifically HIV/AIDS, TB and malaria, as significant numbers of the population are considerably affected by these diseases.
There is little emphasis on oncology or other lifestyle/metabolic diseases, although there is a rapid increase in the prevalence of these illnesses.
Accordingly, cooperative clinical trial groups, sponsored by the National Cancer Institute, have started to work in the Africa region, demonstrating a great interest in bringing cancer therapies to Africa.
Alongside oncology, such as cervical cancer, other emerging topics are metabolic and other lifestyle diseases such as maternal and infant health, diabetes, ischemic heart diseases and strokes and lower respiratory infections.
COVID-19 as the big revealer
The African Academy of Sciences (AAS) recently launched the first carnation of the Clinical Trials Community (CTC) online platform in an effort to boost the visibility of African clinical trial sites and investigators with the possibility of contributing to COVID-19 clinical trials, with a final objective of promoting the progression of intra-African collaboration around clinical trials.
As previously indicated, only a small percentage of clinical trials are conducted in Africa: COVID-19 has revealed why this necessitates immediate change.
While there are vast movements across the industry to invest in COVID-19 vaccines, the outcomes of such COVID-19 studies will be limited to the patient population exposed to the trial. In the end, these vaccines may not be relevant for people in African countries, unless the studies are carried out locally.
This is because responses to vaccines or drugs are part of a complicated process and can be dependent on, among other things, human genetics as different people respond to different drugs and vaccines in different ways.
It is vital and urgent that more countries on the African continent become involved in the clinical trials so that the acquired data can be representative of the entire continent.
Time is of the essence and the standard approach of developing site- or country-specific protocols won’t work. Instead, African governments must look at ways to reconcile the response towards COVID-19 across the continent. It is as important today as ever before that African countries work together.
Each country’s epidemic preparedness kit should contain funds dedicated to clinical trials in the event of an epidemic or pandemic. This would require governments on the African continent to assess their role and level of investment in the broad area of clinical trials.
This will influence the quality and quantity of clinical trials in the…
Read More:How Africa could become a new center for clinical trials