The World Health Organisation (WHO), in its quest to find efficacious therapies to treat COVID-19, plans to conduct a multi-arm, multi-country clinical trial. The trials have yet to begin, but ten countries have already signed up. Only one of them, South Africa, is on the African continent.
Of course, the WHO isn’t the only organisation trying to find treatments or even a vaccine for COVID-19. The United States National Institutes of Health maintains an online platform that lists all registered, ongoing clinical trials globally. On March 26, a quick search of the platform using the term “coronavirus” revealed 157 ongoing trials; 87 of these involve either a drug or a vaccine, while the rest are behavioural studies. Only three are registered in Africa – all of them in Egypt.
This low representation of African countries in clinical trials is not unusual. Poor visibility of existing sites, limited infrastructure and unpredictable clinical trial regulatory timelines are some of the key issues hindering investments in this area.
Africa’s virtual absence from the clinical trials map is a big problem. The continent displays an incredible amount of genetic diversity. If this diversity is not well represented in clinical trials, the trial findings cannot be generalised to large populations.
The same goes for the outcomes of the COVID-19 studies. They too may not be relevant for people in African countries unless conducted locally. This is because responses to drugs or vaccines are complicated and can be influenced by, among other things, human genetics: different people will respond differently to different drugs and vaccines.
More countries on the African continent must urgently get involved in clinical trials so that the data collected will accurately represent the continent at a genetic level.
Time is of the essence. The usual approach, of developing site or country specific protocols, won’t work. Instead, African governments need to look at ways to harmonise the response towards COVID-19 across the continent. Now, more than ever, African countries need to work together.
Centres of excellence
Africa does have clinical trial infrastructure and capabilities. But the resources remain unevenly distributed. The vast majority are in Egypt and South Africa. That’s because these countries have invested more heavily in research and development than others on the continent.
Traditionally, clinical trials are conducted at centres of excellence, which are sites that have the appropriate infrastructure and human skills necessary to conduct good quality trials. These can be located at a single university or research organisation, or work can be split between a few locations. But setting up these centres requires significant time and financial investment. Most that I am aware of on the continent have developed over the years with heavy support from external partners or sponsors. In many cases, African governments have not been involved in these efforts.
Once such centres are set up, the hard work continues to maintain these centres and to ensure they’re able to attract clinical trial sponsors. They require continuous funding, the establishment of proper institutional governance and the creation of trusted, consistent networks.
Usually African scientists leading clinical trial sites can apply for funding to conduct a trial; if the site is well known the scientists may be approached by a sponsor such as a pharmaceutical company interested in conducting a trial.
Clearly this approach takes time and usually benefits well-known sites or triallists. So what alternatives are available in the face of an epidemic that’s moving as fast as COVID-19?
How to change direction
Key stakeholders should work together to expedite the rollout of trials in different countries. This would include inter-country collaborations such as working with different governments and scientists in co-designing trials; and providing harmonised guidelines on patient management, sample collection and tracking and sharing results in real time.
African governments, meanwhile, should provide additional funding to clinical research institutions and clinical trial sites. This would allow the sites to pull resources together and rapidly enrol patients to answer various research questions.
Because of the uneven distribution of skills and resources the continent should also adopt a hub-and-spoke model in its efforts. This would involve countries that don’t have much capacity being able to ship samples easily across borders for analysis in a centralised well-equipped laboratory, which then feeds back data to the country of sample origin.
Governments should also form a task force to quickly engage with key pharmaceutical companies with drug candidates for COVID-19. This team should establish the companies’ appetite for collaborations in conducting relevant trials on the continent.
Through all of this, it is necessary for stakeholders to identify and address key ethical issues that may arise. Ethics should not be compromised by haste.
Every country’s epidemic preparedness kit should contain funds set aside for clinical trials during epidemics or pandemics.
This would require governments on the continent to evaluate their role and level of investment in the general area of clinical trials. This will augment the quality and quantity of clinical trials in the face of the constant challenge of emerging and re-emerging infectious diseases as well as a steady rise in non-communicable diseases.
On top of this, clinical trial centres, clinical research institutions and clinical triallists on the continent should strive to increase their visibility in the global space. This will make them easy to find in times of crisis, and enhance both south-south and north-south collaborations.
The African Academy of Sciences is currently building an online platform to facilitate this visibility and encourage greater collaboration.