Community Health Workers in clinical research at the example of a phase IIIb/ IV antimalarial drug trial conducted in five African countries.

Global health, particularly in underserved settings can benefit immensely from well-trained Community Health Workers (CHWs) supporting primary healthcare interventions. It can reduce morbidity and mortality of infectious diseases like malaria. Disease control programmes can particularly benefit from a tight link between CHWs and communities and several studies have shown the benefit of the participation of non-facility based CHWs in malaria control programme activities for reducing malaria-related mortality in children. Because CHWs are often part of, and trusted by, served communities, they can also be an important resource to address challenges faced by their communities. Where post-marketing surveillance systems are underserved, they can relay important information about suspected safety signals and factors affecting therapeutic effectiveness in their communities. The CANTAM-Pyramax® (pyronaridine-artesunate or PA) trial was a phase IIIb/ IV cohort event monitoring study conducted at six centres in five African countries. To assess real-world effectiveness and safety of the anti-malarial PA in 8,560 malaria episodes, follow-up was not primarily conducted by medical staff but by specifically trained CHWs. This perspective paper discusses how the participation of a CHW workforce can be of benefit for effectiveness trials in limited-resource settings, using the example of the CANTAM-Pyramax trial.