Evaluating antimalarial efficacy in single-armed and comparative drug trials using competing risk survival analysis: a simulation study
Prabin Dahal, Philippe J Guerin, Ric N Price, Julie A Simpson, Kasia Stepniewska
BMC MEDICAL RESEARCH METHODOLOGY | BMC | Published : 2019
BACKGROUND: Antimalarial efficacy studies in patients with uncomplicated Plasmodium falciparum are confounded by a new infection (a competing risk event) since this event can potentially preclude a recrudescent event (primary endpoint of interest). The current WHO guidelines recommend censoring competing risk events when deriving antimalarial efficacy. We investigated the impact of considering a new infection as a competing risk event on the estimation of antimalarial efficacy in single-armed and comparative drug trials using two simulation studies. METHODS: The first simulation study explored differences in the estimates of treatment failure for areas of varying transmission intensities usi..View full abstract
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Awarded by Australian Centre of Research Excellence on Malaria Elimination
PD is funded by Tropical Network Fund, Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford. The WorldWide Antimalarial Resistance Network (PD, KS, RNP, and PJG) is funded by a Bill and Melinda Gates Foundation grant and the ExxonMobil Foundation. JAS is an Australian National Health and Medical Research Council Senior Research Fellow (1104975). RNP is a Wellcome Trust Senior Fellow in Clinical Science (200909). This work was supported in part by the Australian Centre of Research Excellence on Malaria Elimination (ID#1134989). The funders did not participate in the study development, the writing of the paper, decision to publish, or preparation of the manuscript.