Accounting for dropout in xenografted tumour efficacy studies: integrated endpoint analysis, reduced bias and better use of animals.

ABSTRACT:

Purpose

Xenograft studies are commonly used to assess the efficacy of new compounds and characterise their dose-response relationship. Analysis often involves comparing the final tumour sizes across dose groups. This can cause bias, as often in xenograft studies a tumour burden limit (TBL) is imposed for ethical reasons, leading to the animals with the largest tumours being excluded from the final analysis. This means the average tumour size, particularly in the control group, is underestimated, leading to an underestimate of the treatment effect.

Methods

Four methods to account for dropout due to the TBL are proposed, which use all the available data instead of only final observations: modelling, pattern mixture models, treating dropouts as censored using the M3 method and

SUBMITTER: Martin EC 

PROVIDER: S-EPMC4921113 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature