Nine out of ten deaths from malaria occur in sub-Saharan Africa. Although various control measures have achieved progress in the control of the disease, malaria is still a major public health problem in Africa, and more work is needed to evaluate new interventions and those currently in use. Randomized controlled trials (RCTs) are universally considered the best study type to rigorously assess whether an intervention is effective. This article reports on a systematic, descriptive analysis of RCTs of malaria prevention and treatment conducted in Africa between 1948 and 2007. The aim is to provide detailed information on the main clinical and methodological characteristics of these RCTs, that could be used by researchers and policy makers to help plan future research. The authors found that the majority of African malaria RCTs investigated drug treatment in children with uncomplicated malaria. Few trials reported on treatment of severe malaria or on interventions in pregnant women. Sources of funding and trial methodological quality were often poorly reported. Although three-quarters of trials provided information on participants' informed consent and ethics approval, more details and clear reporting are needed. Prospective trial registration will help.
Malaria Journal (2011) 10: 61 [doi:10.1186/1475-2875-10-61]