Exploring a model-based analysis of patient derived xenograft studies in oncology drug development.

ABSTRACT:

Purpose

To assess whether a model-based analysis increased statistical power over an analysis of final day volumes and provide insights into more efficient patient derived xenograft (PDX) study designs.

Methods

Tumour xenograft time-series data was extracted from a public PDX drug treatment database. For all 2-arm studies the percent tumour growth inhibition (TGI) at day 14, 21 and 28 was calculated. Treatment effect was analysed using an un-paired, two-tailed t-test (empirical) and a model-based analysis, likelihood ratio-test (LRT). In addition, a simulation study was performed to assess the difference in power between the two data-analysis approaches for PDX or standard cell-line derived xenografts (CDX).

Results

The model-based analysis had greater statisti

SUBMITTER: Dickinson J 

PROVIDER: S-EPMC7847196 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature