Although 18% of the world’s population lives in Africa, only 3% of clinical trials are conducted on the continent, with an ambition to increase this to 15% by 2035.
However, this requires significant improvements across several aspects, including more innovative trial designs and better use of digital tools. This was the subject of a recent webinar hosted by the International Federation of Pharmaceutical Manufacturers (IFPMA) as part of the African Regulatory Conference..
Several organizations are working to improve the capacity to host trials in Africa.
The African Clinical Research Network (ACRN) supports the conduct of high-quality clinical trials by networking with researchers, training and building capacity, said Chief of Staff Dr. Romina Mariano.
“Our approach is focused on improving the quality of trials across sites, accelerating the recruitment of trial startups, and building long-term capacity and sustainability,” she said during the webinar.
“More than 70% of U.S. oncology studies fail to meet enrollment goals on time. Costs are skyrocketing, and Africa, by contrast, has a rapidly expanding young population, rapidly expanding health care infrastructure, and increasing regulatory maturity. Therefore, for sponsors globally, Africa is essential to solving today’s clinical trial bottlenecks,” she added.
ACRN currently serves as a clinical trial site management organization and provides “modular trial conduct services” including laboratory services and logistics.
It applies a “digital-first approach” with a “robust digital operating system” that includes AI-enabled capabilities and pharmacovigilance.
Focus on regulators
Kwasi Nyarko leads the World Health Organization (WHO) initiative. Promoting excellent clinical trials in Africa ((abbreviated as AVAREF).
AVAREF focuses on improving the skills of national regulatory authorities that oversee clinical trials, including ethics oversight.
Nyarko said the company is currently piloting the service with 16 countries, with three judges in each country being trained.
But a lack of clinical trials makes it difficult for examiners to gain practical experience, he said.
Currently, the continent’s approach is “fragmented” and AVAREF is working towards a situation where approval of a trial by one country in the network means that it is also approved in all other countries.
“Traditional clinical trials tend to be expensive. The cost is prohibitive,” Nyarko says. “So we are starting to see new and innovative trial designs using digital tools.”
“We have a digital working group that looks at the IT systems we need, and that platform is actually being developed courtesy of the Gates Foundation and CEPI (Coalition for Epidemic Preparedness Innovations).”
“We want reviewers from multiple sites to be able to work on a similar platform and review dossiers.”
The European Medicines Agency, the U.S. Food and Drug Administration, and Health Canada support AVAREF.
Introducing African trials
Technology company based in South Africa Nuvote QDevelops software products for clinical and pharmaceutical research organizations. Clinical Trials Community (CTC) Africa.
CEO Adrian Kruger said CTC aims to attract investment in clinical trials in Africa by showcasing African clinical trialists and research facilities.
This is an “interactive platform” that provides access to site registration, site feasibility data, and country-specific regulatory and ethical information to make it easier for sponsors to find and partner with research sites in Africa.
“We have a database of about 30,000 clinical trials that we know of, and we have pretty clean data within the registry where these trials are listed,” Krueger said.
WHO Forum
Dr. Vassie Moorthy, who leads WHO’s clinical trial efforts, said in a webinar that WHO recently World Clinical Trials Forum Strengthen your trial environment and infrastructure.
“This includes 27 organizations and we are actively seeking more African participants,” Moorthy said.
The forum will be held following the 2022 World Health Assembly solution Regarding strengthening clinical trials.
During the webinar, we also heard case studies about innovative clinical trials. GSK used a Facebook-based application integrated with WhatsApp to collect data on drug side effects from patients in Brazil’s Amazon region.
Although this study showed that this technology allows for follow-up of adverse events and pregnancy, the study was limited by small sample size and low response rate.
The Roche Recovery trial is the largest COVID-19 treatment study, designed to address the urgent need for effective treatments for COVID-19 while minimizing the burden on frontline hospital staff. This study used real-world evidence from electronic medical records to demonstrate the efficacy of tocilizumab in treating COVID-19.
Speakers emphasized the importance of innovative trial designs, especially in low-income settings. The use of free digital tools such as WhatsApp is especially important.
In the webinar, innovative clinical trial design and digital technology; It was the third 4-part online african regulatory council Sponsored by IFPMA. The final webinar will be held on November 25th and will focus on streamlining regulatory and ethical approvals for clinical trials. Anyone interested can register.
Image credit: University of Oxford/Tom Wilkinson.
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