The challenge of conducting clinical trials in remote and conflict areas

The journey to the sleeping sickness trial site in Isangi from the DNDi office in Kinshasa begins in the domestic airport of DRC’s capital city and ends more than a day later halfway across the country in a barge crossing the Congo river. In between: hours spent navigating potholed dirt roads, collapsed bridges, checkpoints, and multiple river crossings. Once at Isangi, canoes must be used to reach many of the patients as there are no roads.

Yet for DNDi’s clinical team in DRC, Isangi is one of the easier-to-reach sites. The DRC and the Central African Republic (CAR) both pose daunting challenges that must be overcome to develop better treatments for patients suffering from sleeping sickness.

Sign outside of hospital in DRCPolitical instability is a major challenge. Armed conflict in CAR forced DNDi to stop recruitment of patients in 2013. “Despite this constraint, we managed to follow-up more than half of the patients who had been treated,” says Dr Francis Regongbenga, Principal Investigator for CAR at the Batangafo site.

A second important challenge is infrastructure. It is imperative that wards, labs, and other facilities conduct clinical research that is up to par with ‘Good Clinical Practice’ (GCP). Clinical trial sites were brought up to these standards – not a small task considering their remote location. Nine referral treatment units were renovated and refurbished, with solar energy equipment and generators installed. Equipment was brought in: defibrillators and tools such as the Piccolo analyser – a fully automated system for blood testing. Internet access was installed to enable transmission of case report forms, particularly necessary for the monitoring of safety parameters.

With the fexinidazole clinical trial, everything changed. Not only does our hospital no longer look like a farm, but the community benefits from a modern facility and our work is easier,” says Watson Tawaba, nurse at the Bagata site in DRC. Overcoming the lack of trained staff is another hurdle. Through the HAT Platform – a clinical research network to strengthen capacities in endemic regions set up with the support of DNDi in 2005 – trainings were provided in diagnostic and treatment procedures, pharmacovigilance, GCP guidelines, and even medical waste management. The joint experience of DNDi and the national sleeping sickness programme in the DRC shows it is possible to build an environment conducive to running quality clinical trials. These efforts build and sustain the capacity to conduct a high standard of clinical research in endemic countries, but they also bring lasting benefits to researchers, staff and hospitals, as well as to health systems more broadly, and thus ultimately to local communities and patients.

 

Photo credit: Neil Brandvold/DNDi