Polymerase Chain Reaction Adjustment in Antimalarial Trials: Molecular Malarkey?

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Abstract
Malaria drug trials use both clinical and microbiologic end points to establish efficacy. The recurrence of parasitemia after treatment is an indicator of treatment failure. The study by Faucher et al. [1] from Benin in this issue of the Journal demonstrates both substantial in vivo resistance to sulfadoxine‐pyrimethamine (SP) and good effectiveness of 2 new artemisinin combination therapies (ACTs): artemether‐lumefantrine (AL) and artesunate‐amodiaquine (ASAQ). Both ACTs were markedly more effective than SP. Of note, in the per‐protocol analysis, there were significantly fewer recurrent episodes of parasitemia in the AL group than in the ASAQ group, but there was no difference after polymerase chain reaction (PCR) adjustment (often called PCR correction). Are the ACT regimens equivalent, or is AL better?. The answer hinges on whether PCR correction truly corrects.