Conducting clinical trials in Africa: Challenges and strategies for capacity-building

Clinical trials are essential for the development of safe and effective medicines and are crucial to improving the outcomes of clinical care and finding solutions to challenges in disease management. For scientists to test the efficacy and safety of medicines or a therapy, clinical trials must be carried out.

However, although some studies show an increase in the number of clinical trials in Africa in recent years, it is only a tiny amount compared to clinical trials conducted in other parts of the world. Africa still lags significantly behind and continues to face challenges in building capacity for conducting sustainable clinical trials on the continent. Majority of the clinical trials in Africa are conducted in South Africa or Egypt, while many other African countries hardly conduct any clinical trials at all.

According to the US Foods and Drug Administration (FDA), in 2018, only 4% of patients enrolled in clinical trials which led to new cancer drugs were of African descent. Likewise, only less than 2% (917) of the 68,673 cancer studies that were listed in Clinical Trials.gov, were conducted in Africa.

The African continent has 25% of the global disease burden, and a significant portion of the neglected and tropical diseases

Africa should be a clinical trial powerhouse

Africa has many of the best conditions for conducting clinical trials. The continent has a vast population of potential patients from diverse ethnic backgrounds, many of whom have never received any pharmaceutical treatment for their disease, and thus provides a source of potentially accurate research findings. Also, the African continent has 25% of the global disease burden, and a significant portion of the neglected and tropical diseases, which are endemic to developing countries.

With these clinical advantages, Africa ought to be a powerhouse of clinical trials, as it is expected that clinical trials for medicines are conducted in the areas most affected by the diseases the medicines intend to treat. Unfortunately, this is not the case, as the successful conduction of clinical trials in Africa faces many challenges.

Challenges limiting Africa’s capacity to conduct clinical trials

Several challenges make it difficult to sustainably conduct clinical trials in Africa. They include:

· Regulatory barriers caused by inconsistent ethical guidelines across the continent, hence poor legislative protection for participants in trials

· Operational barriers regarding study initiation, study population, and cultural factors

· Poor infrastructure; recent reports reveal that only seven medical laboratories in Nigeria have achieved international regulatory standard, out of 5,349

· Inadequate capacity building, due to insufficient training of research personnel to carry out clinical trials that meet global standards.

Read also:WHO sets up hub to train Nigeria, others on vaccine production

Consequences of lack of significant clinical trials on the continent

A major consequence of Africa’s poor capacity to conduct clinical trials is that it prevents the availability of ‘suitable’ medicines on the continent. Certain diseases are more prevalent in particular ethnic groups and the genetic makeup of individuals influences their response to treatment. It is therefore often clinically inappropriate to extrapolate research findings from the Global North to the African population.

Therefore, limited clinical trials in Africa make it difficult for the continent to tackle its growing disease burden, especially non-communicable diseases which have been estimated by the World Health Organisation (WHO) to become the leading cause of diseases in Africa in the next decade.

Strategies to build sustainable capacity in Africa for clinical trials

A collaborative effort from governments, pharmaceuticals firms, universities, research institutes, the private sector, funders, sponsors and other stakeholders is essential to achieving sustainable capacity-building. Specific steps that must be taken include:

1. The development of a set of uniform, pan African guidelines: These guidelines can be developed by the African Union, similarto what has been done by the European Union, which created ethical guidelines for all its member states. This will provide legislative protection for participants and increase participants’ retention in trials. NAFDAC and a few African countries have stepped up in recent years on clinical trial guidelines, but it needs to be African wide.

2. The establishment of clinical trials research hubs across Africa: There is a need for the strengthening of current research sites in Africa and the establishment of new ones with the capacity for sustainable research. This will provide reliable sites, having the required infrastructure, staffing, and systems to effectively conduct clinical trials. Such capacity can be developed by the establishment of clinical trial hubs across Africa through the collaboration of partners in the industry and academia.

3. Capacity-building through training of African researchers by conducting a variety of training programmes, and the provision of grants to early career investigators. A few scientists on the continent are making very encouraging steps in this direction, but the urgency of this requires that it be scaled up with the necessary funding and technical support.

Although Africa still lags behind in conducting clinical trials, the COVID-19 pandemic has led to a building up of momentum in the continent’s research and development space. We believe that through strategic partnerships and collaborations across the continent, Africa can build capacity to sustainably conduct clinical trials that tackle its growing disease burden.

Professor Anyakora is the CEO of Bloom Public Health and a public health expert.

Odibeli is a pharmacist and the Research and Communications Coordinator at Bloom Public Health.