The effect of varying analytical methods on estimates of anti-malarial clinical efficacy

Malaria Journal

Table 2 Analytical methods used to generate estimates of anti-malarial drug efficacy.

	Outcome Category	Unadjusted by genotyping			Adjusted by genotyping
		ITT	mITT	PP	ITT	mITT	PP
	Follow-up interrupted	Failure	Censored	Excluded	Failure	Censored	Excluded
	ACPR	Success	Success	Success	Success	Success	Success
	ETF	Failure	Failure	Failure	Failure	Failure	Failure
LCF and LPF	Recrudescence	Failure	Failure	Failure	Failure	Failure	Failure
	P. falciparum new infection	Failure	Failure	Failure	Success	Censored	Excluded
	Genotyping unsuccessful	Failure	Failure	Failure	Failure	Excluded	Excluded
	Non-falciparum new infection	Success	Censored	Excluded	Success	Censored	Excluded

ITT = intention-to-treat; mITT = modified intention-to-treat; PP = per protocol
ACPR = adequate clinical and parasitological response; ETF = early treatment failure; LCF = late clinical failure; LPF = late parasitological failure
Note: Although the general principles behind these analytical approaches are well-described, in practice differences arise in the way in which the outcome measures may be classified, depending on the rationale of the study. The Table reflects only one set of options and is not definitive for all antimalarial studies.

ISSN: 1475-2875