Although 18% of the world’s population lives in Africa, only 3% of clinical trials are conducted on the continent – and the ambition is to increase this percentage to 15% by 2035.

But this requires substantial improvements across several aspects – including more innovative trial designs and better use of digital tools – the subject of a recent webinar hosted by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) as part of its African Regulatory Conference.  

Several organisations are working to improve Africa’s ability to host trials.

The Africa Clinical Research Network (ACRN) supports the implementation of high-quality clinical trials by networking with researchers, training, and building capacity, says chief-of-staff Dr Romina Mariano.

“Our approach is focused on the trial quality across sites, the acceleration of study startup recruitment, and building long-term capacity and sustainability,” she told the webinar.

“Over 70% of oncology studies in the US failed to meet enrollment targets on time. Costs are rocketing, and Africa, by contrast, offers rapidly expanding young populations, rapidly expanding healthcare infrastructure and increasing regulatory maturity. So for global sponsors, Africa is essential to solving today’s trial bottlenecks,” she added.

ACRN functions currently as a trial site management organisation, offering “modular trial execution services” that include laboratory services and logistics.

It applies a “digital-first approach” with a “robust digital operating system” including  AI-enabled features and pharmacovigilance.

Focus on regulators 

Kwasi Nyarko heads the World Health Organization (WHO) initiative, Advancing Clinical Trials Excellence in Africa (abbreviated as AVAREF).

AVAREF focuses on improving the skills of national regulators to oversee clinical trials, including ethics oversight.

It is currently working on a pilot with 16 countries, each of which has availed three reviewers for training, said Nyarko.

However, he says that the lack of clinical trials makes it difficult for the reviewers to get practical experience.

Currently, the continent’s approach is “fragmented”, and AVAREF is working towards a situation where trial approval by one country in the network means it can be approved in all the other countries.

“Traditional trials tend to be expensive. Cost is prohibitive,” said Nyarko.  “So we are beginning to see new, innovative trial designs using digital tools.”

“We have a digital working group that’s looking at the IT system that we need and the platform is actually being developed, courtesy of the Gates Foundation and CEPI [Coalition for Epidemic Preparedness Innovations].”

“We want to ensure that reviewers from multiple sites can work on a similar platform and review dossiers.”

The European Medicines Agency, the US Food and Drug Administration and Health Canada are assisting AVAREF.

Showcasing African trials

The South African-based tech company nuvoteQ, which develops software products for clinical and pharmaceutical research organisations, has set up an online platform called the Clinical Trials Community (CTC) Africa.

CEO Adriaan Kruger said CTC aims to attract investment in African clinical trials by showcasing the continent’s clinical trialists and research sites. 

It is an “interactive platform” that provides a registry of sites, data on site feasibility, and access to country-specific regulatory and ethics information to make it easier for sponsors to find and partner with African research locations. 

“We have a database of about 30,000 trials that we know of, and within the registry where these trials are listed, we have fairly clean data,” said Kruger.

WHO forum

Dr Vasee Moorthy, who leads the WHO’s work on clinical trials, told the webinar that the WHO had recently launched a Global Clinical Trials Forum to strengthen the trial environment and infrastructure.

“It includes 27 organisations and is actively seeking more African participants,” said Moorthy.

The forum follows from a 2022 World Health Assembly resolution on strengthening clinical trials.

The webinar also heard case studies about innovative trials. GSK used a Facebook-based application integrated with WhatsApp to collect data about the adverse effects of medicines from patients in Brazil’s Amazon region.

While the study showed that the technology enabled the follow-up of adverse events and pregnancies, the study was limited due to a small sample size and low response rate.

Roche’s Recovery trial, the largest COVID-19 treatment study, was designed to address the urgent need for effective treatments for COVID-19 while minimising the burden on frontline hospital staff. Using real-world evidence from electronic health records, the study demonstrated the effectiveness of Tocilizumab in treating COVID-19.

Speakers stressed the importance of innovative trial designs, particularly in low-income settings. The use of free digital tools such as WhatsApp are particularly important.

The webinar, Innovative clinical trial designs and digital technologies, was the third of a four-part online African Regulatory Conference hosted by IFPMA. The final webinar is on 25 November, and focuses on streamlining regulatory and ethics approval for clinical trials. Anyone who is interested can register.

Image Credits: University of Oxford/ Tom Wilkinson.