Clinical trial capacity where it’s needed most
It is almost night and Dr Felix Akwaso carefully navigates a muddy, winding road on his motorcycle deep in Kwilu Province in the Democratic Republic of the Congo (DRC). On the back of his bike: a patient from a remote village that tested positive for the worms that cause river blindness. This is just part of a day’s work for Dr Felix, who is the Principal Investigator for DNDi’s river blindness trial at Masi-Manimba General Reference Hospital. He drops off the patient and prepares for a full day of extracting the worm-containing ‘nodules’ from patients. These nodules will be tested to see how the investigational treatment works against these filarial worms.
Dr Felix was central to kicking off one of two new Phase II studies for river blindness initiated by DNDi and partners in 2021, but he and his team are no strangers to clinical trials. In 2012, DNDi began its trials here for sleeping sickness – renovating the hospital ward, training staff, and getting the site up to international standards. No one at the hospital had ever worked on a clinical trial, but six years later their hard work paid off with the registration of the first all-oral treatment for sleeping sickness – an achievement Dr Felix is immensely proud of.
Like so many regions of the DRC, people in this area are at risk of multiple NTDs. Locating trials for new treatments in affected communities is key for DNDi, and the researchers at Masi-Manimba are a shining example of the committed partners who propel our shared progress. Dr Felix thinks the sky is the limit for his team at Masi. ‘For the team here, this is a huge scientific step forward. Maybe we can even start running trials for other diseases,’ he says.
Data for good: Eastern Africa innovation
Another example of DNDi’s work to maximize clinical research capacity in Africa is its Data Management and Biostatistics (DMB) Centre, established in Nairobi, Kenya, in 2004. The only operation of its kind in Africa, the DMB Centre not only helps DNDi run studies in remote areas of Eastern Africa, but also provides a vital service to other organizations through data management and statistical analysis for clinical trials throughout the region.
Quality data is the bedrock of clinical research, providing essential information on patient enrolment and drug safety and efficacy. Prompt transfer of data from remote clinical trial locations in Kenya, Uganda, Sudan, Ethiopia, and other Eastern African countries can be a challenge, particularly in areas where internet connectivity is unavailable or unreliable.
In 2021, the Centre adopted an electronic data capture system to retrieve data in real time from clinical trial sites for faster review, analysis, and sharing. ‘In the past, we had to wait for weeks before getting data,‘ said Dr Yaw Asare-Aboagye, Head of Global Clinical Operations at DNDi. With the new system, the process is almost instantaneous.
Since its inception, the Centre has managed data for over a dozen clinical trials for leishmaniasis, multidrug-resistant tuberculosis, paediatric HIV, Buruli ulcer, and mycetoma – including with partner organizations such as the World Health Organization (WHO), Médecins Sans Frontières (MSF), and the Kenya Medical Research Institute.
Cynthia’s story
Photo credits: Abraham Ali-DNDi; Brent Stirton/Getty Images; Karin Schermbrucker-DNDi
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