Phase i trials in melanoma: A framework to translate preclinical findings to the clinic.

ABSTRACT:

Background

One of major issues in clinical trials in oncology is their high failure rate, despite the fact that the trials were designed based on the data from successful equivalent preclinical studies. This is in part due to the intrinsic homogeneity of preclinical model systems and the contrasting heterogeneity of actual patient responses.

Methods

We present a mathematical model-driven framework, phase i (virtual/imaginary) trials, that integrates the heterogeneity of actual patient responses and preclinical studies through a cohort of virtual patients. The framework includes an experimentally calibrated mathematical model, a cohort of heterogeneous virtual patients, an assessment of stratification factors, and treatment optimisation. We show the detailed process through t

SUBMITTER: Kim E 

PROVIDER: S-EPMC5658204 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature