Analysis of Impact of Post-Treatment Biopsies in Phase I Clinical Trials.

ABSTRACT:

Purpose

The use of biopsy-derived pharmacodynamic biomarkers is increasing in early-phase clinical trials. It remains unknown whether drug development is accelerated or enhanced by their use. We examined the impact of biopsy-derived pharmacodynamic biomarkers on subsequent drug development through a comprehensive analysis of phase I oncology studies from 2003 to 2010 and subsequent publications citing the original trials.

Methods

We conducted a search to identify and examine publications of phase I oncology studies including the use of biopsy-derived pharmacodynamic biomarkers between 2003 and 2010. Characteristics of those studies were extracted and analyzed, along with outcomes from the biomarker data. We then compiled and reviewed publications of subsequent phase II and I

SUBMITTER: Sweis RF 

PROVIDER: S-EPMC4872035 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature