Analysis of Impact of Post-Treatment Biopsies in Phase I Clinical Trials [Phase I and Clinical Pharmacology]

Conclusion Despite their increased use, the impact of biopsy-derived pharmacodynamic biomarkers in phase I oncology studies on subsequent drug development remains uncertain. No impact on subsequent dose or schedule was demonstrated. This issue requires further evaluation, given the risk and cost of such studies.

http://jco.ascopubs.org/cgi/content/short/34/4/369?rss=1

Source: Journal of Clinical Oncology - January 25, 2016 Category: Cancer & Oncology Authors: Sweis, Drazer, Ratain Tags: Clinical Trials, Phase I and Clinical Pharmacology, Cancer Biomarkers, Phase I and Clinical Pharmacology Source Type: research