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 face of the persistent global challenge of emerging and re-emerging infectious diseases, as well as a steady increase in non-communicable diseases.
Moreover, clinical trial centers and clinical research institutions on the continent should be motivated to improve their visibility in the global space. This will make them easy to identify in times of crisis and promote both south-south and north-south collaborations.
Image Credit: Cerba Research
For the past 37 years, Cerba Research, part of Cerba Healthcare Group, has been focused on central lab activities. It has created a large portfolio of customers based in Europe and the USA looking to expand into the African region to easily enroll participants into both interventional and non-interventional studies.
Cerba Research can draw on the support of the Cerba HealthCare and Lancet networks, who have partnered to become the medical, biological and diagnostic leaders in Africa.
With more than 11,000 collaborators who are invested in the same objective of providing physicians, patients, pharmaceutical and biotech companies with superior healthcare services, Cerba and Lancet make sure that patients, regardless of their geographical location, profit from proximity quality and pioneering biology.
This joint venture is accompanied by the successful collaboration between the two diagnostic leaders and generates a network with coverage in over 23 African countries.
The founding of this joint venture and the enhanced resources within the group in Africa make this an optimal opportunity for Cerba Research to further develop its involvement across the African continent and become the global leader in central laboratory services in Africa.
Prior to the founding of CerbaLancet – the partnership with Lancet Laboratories – Cerba Research (formerly BARC) has had the capacity to install and manage clinical trials in Africa for two decades.
With a team based locally in Johannesburg, BARC South Africa has performed over 250 trials across a broad range of therapeutic areas.
Working in close collaboration with the US Department of Health (NIH), NGOs, CROs and pharmaceutical companies, Cerba has localized expertise which enables the company to expand and execute trials in the entire Africa region, taking BARC South Africa as an example.
Such expansion can be perceived in the rest of Africa as the laboratory infrastructure improves and acts as a catalyst for carrying out clinical trials across the whole Africa region.
Image Credit: Cerba Research
Biobanking in Johannesburg, South Africa
BARC South Africa has a certified Sample Repository (Biobank) in Johannesburg, South Africa.
The biobanking facility in Johannesburg was initiated in October 2009 and has been developed for the storage of over seven million clinical samples (6.4 million samples at -80 °C; a dedicated ambient storage area and 760,000 samples in the liquid nitrogen vapor phase) and is incorporated into the central laboratory services.
Available storage conditions include Ambient (20 °C to 30 °C), refrigerated (2 °C to 8 °C), frozen (-20 °C, -80 °C and -196 °C). There are presently around 3.2 million clinical trial samples held in storage at -80 °C, and 500,000 PBMC samples in the vapor phase of liquid nitrogen.
The BARC South Africa biobank is engaged in research focused on the long-term storage preservation of mycobacteria in different media with the ACTG being a part of the TB Quality Assurance Advisory Group.
Continual internal auditing is performed by the quality assurance officer on all work that staff conduct to check for integrity of sample processing, storage and source data recording, with continuous training and development of all staff as necessary.
All samples are 100% quality assured on entry and before being dispatched from the facility.
Additionally, vigorous methods have been designed for when receiving samples into the biobanking unit, sample processing and storage within the Biobanking unit as well as sample distribution from the Biobanking unit.
These methods include pre-notification steps, quality control into the laboratory management system, shipment approvals, management of permits (import and export), capturing of shipments and sample issues reported on a specimen discrepancy report (SDR) and rapid and accurate retrieval of samples.
All shipping carried out is done according to IATA standards. Thus, the biobank has the capacity to distribute frozen specimens to destinations across the globe for further research and development in line with international guidelines and recommendations.
A system named Citect Scada (FDA approved) is established to guarantee real-time continuous monitoring of the temperature, equipment’s electronic processing systems, liquid detection monitors, appropriate oxygen levels and relative equipment failures across the facility.
In case of error, all are documented electronically with SMS notification via two independent service providers to the standby staff.
About Cerba Research
For over 35 years, Cerba Research has been setting the industry standard for exemplary clinical trial conduct. Today, across five continents, with a focus on precision medicine, we are changing the paradigm of the central lab’s role in complex clinical research.
From protocol inception through development and to market, our passionate experts deliver the highest quality specialized and personalized laboratory and diagnostic solutions. Partner with us for the most efficient strategy to actualize your biotech and pharmaceutical products sooner and improve the lives of patients worldwide.
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