WWRN Researchers conducted a scoping literature review to evaluate how the eligibility criteria used in anti-malarial efficacy and safety trials translate into patient selection.
Among the 176 studies included in the analysis, nearly two-thirds of the malaria-positive subjects who presented at medical facilities were excluded from anti-malarial treatment trials, and the reason for almost one-third of them was not reported.
For the results of clinical trials to have external validity, the patients included in the study must be representative of the population presenting in the general clinical settings. The studies generally adhere to the current WHO methodological recommendations, which aim at assessing drug efficacy in a consistent way, in order to detect and monitor drug resistance. However, researchers suggest pragmatic trials are also necessary to supplement the information currently available and improve the external validity of the findings of malaria clinical trials.