Study finds almost two-thirds of patients are systematically excluded from drug trials
A new WWARN study has found that nearly two-thirds of the malaria-positive patients who present to health facilities are systematically excluded from "classical" anti-malarial treatment efficacy trials.
Researchers conducted a scoping literature review to evaluate how the eligibility criteria used in anti-malarial efficacy and safety trials translate into patient selection.
The manuscript, "Malaria patient spectrum representation in therapeutic clinical trials of uncomplicated malaria: a scoping review of the literature", published in the Malaria Journal, found that among the 176 studies included in the analysis, nearly two-thirds of the malaria-positive subjects who presented at medical facilities are systematically 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.