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Vipul Jairath, Barrett G Levesque, Niels Vande Casteele, Reena Khanna, Mahmoud Mosli, Pieter Hindryckx, Simon Travis, Marjolijn Duijvestein, Jordi Rimola, Julian Panes, Geert D’Haens, William J Sandborn, Brian G Feagan, Evolving Concepts in Phases I and II Drug Development for Crohn’s Disease, Journal of Crohn's and Colitis, Volume 11, Issue 2, February 2017, Pages 246–255, https://doi.org/10.1093/ecco-jcc/jjw137
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Abstract
The highest attrition rates during drug development programmes occur at the proof of concept stage. Given the large number of molecules under development for Crohn’s disease, a need exists to improve the efficiency of early drug development by fast-tracking promising agents and terminating ineffective ones. Multiple opportunities are available to achieve these goals, including the use of more responsive outcome measures, and the incorporation of sophisticated pharmacokinetic modelling and/or highly specific pharmacodynamic markers into exposure-based dosing regimens and novel trial designs. In this article we review these strategies and propose an integrated paradigm of early drug development in Crohn’s disease.