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Table 4 Challenges in estimating antimalarial drug efficacy and possible alternatives

From: Statistical methods to derive efficacy estimates of anti-malarials for uncomplicated Plasmodium falciparum malaria: pitfalls and challenges

Challenges

Current approach

Alternative approach

Software

Competing risk event

Censored on the day of event [3]

Cumulative incidence function

cmprsk package R [30]

(Additional file 1: Section B)

Interval censoring

Ignored

Interval censored survival estimates

survival package R [57]

(Additional file 1: Section C)

K–M for multicentre studies

No specific recommendation

Use of meta-analysis approach [40]

MetaSurv package R [41]

(Additional file 1: Section D)

Comparing K–M estimates

Current comparison based on whole survival curve (log-rank test)

Comparison at a fixed point in time based on complementary log–log transformation [42]

R script available as additional file

(Additional file 1: Section E)

Demonstrating non-inferiority

Based on the cured proportion

Based on the difference of two K–M estimates after complementary log–log transformation (or on hazards ratio scale)

R script available as additional file

(Additional file 1: Sections F, G, H)