Generalizing boundaries for triangular designs, and efficacy estimation at extended follow-ups.

ABSTRACT:

Background

Visceral leishmaniasis (VL) is a parasitic disease transmitted by sandflies and is fatal if left untreated. Phase II trials of new treatment regimens for VL are primarily carried out to evaluate safety and efficacy, while pharmacokinetic data are also important to inform future combination treatment regimens. The efficacy of VL treatments is evaluated at two time points, initial cure, when treatment is completed and definitive cure, commonly 6 months post end of treatment, to allow for slow response to treatment and detection of relapses. This paper investigates a generalization of the triangular design to impose a minimum sample size for pharmacokinetic or other analyses, and methods to estimate efficacy at extended follow-up accounting for the sequential design and cha

SUBMITTER: Allison A 

PROVIDER: S-EPMC4647805 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature