Evolving Concepts in Phases I and II Drug Development for Crohn's Disease

Vipul Jairath^{1

2

3}, Barrett G Levesque^{2

4}, Niels Vande Casteele^{2

4

5}, Reena Khanna^{1

2}, Mahmoud Mosli⁶, Pieter Hindryckx^{2

7}, Simon Travis³, Marjolijn Duijvestein⁸, Jordi Rimola⁹, Julian Panes⁹, Geert D'Haens^{2

8}, William J Sandborn^{2

4}, Brian G Feagan^{10

2

11}

Affiliations

¹ Department of Medicine, University of Western Ontario, London, ON, Canada.
² Robarts Clinical Trials Inc., Robarts Research Institute, University of Western Ontario, London, ON, Canada.
³ Nufﬁeld Department of Experimental Medicine, University of Oxford, Oxford, UK.
⁴ Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
⁵ KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium.
⁶ Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
⁷ University Hospital of Ghent, Ghent, Belgium.
⁸ Department of Gastroenterology and Hepatology, Academic Medical Centre, Amsterdam, The Netherlands.
⁹ Hospital Clinic of Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
¹⁰ Department of Medicine, University of Western Ontario, London, ON, Canada brian.feagan@robartsinc.com.
¹¹ Department of Epidemiology and Biostatistics, University of Western Ontario, London, ON, Canada.

PMID: 27487793
DOI: 10.1093/ecco-jcc/jjw137

Review

Evolving Concepts in Phases I and II Drug Development for Crohn's Disease

Vipul Jairath et al. J Crohns Colitis. 2017 Feb.

. 2017 Feb;11(2):246-255.

doi: 10.1093/ecco-jcc/jjw137. Epub 2016 Aug 3.

Authors

Affiliations

¹ Department of Medicine, University of Western Ontario, London, ON, Canada.
² Robarts Clinical Trials Inc., Robarts Research Institute, University of Western Ontario, London, ON, Canada.
³ Nufﬁeld Department of Experimental Medicine, University of Oxford, Oxford, UK.
⁴ Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
⁵ KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium.
⁶ Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
⁷ University Hospital of Ghent, Ghent, Belgium.
⁸ Department of Gastroenterology and Hepatology, Academic Medical Centre, Amsterdam, The Netherlands.
⁹ Hospital Clinic of Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
¹⁰ Department of Medicine, University of Western Ontario, London, ON, Canada brian.feagan@robartsinc.com.
¹¹ Department of Epidemiology and Biostatistics, University of Western Ontario, London, ON, Canada.

PMID: 27487793
DOI: 10.1093/ecco-jcc/jjw137

Erratum in

Corrigendum: Evolving Concepts in Phases I and II Drug Development for Crohn's Disease.
Jairath V, Levesque BG, Vande Casteele N, Khanna R, Mosli M, Hindryckx P, Travis S, Duijvestein M, Rimola J, Panes J, D'Haens G, Sandborn WJ, Feagan BG. Jairath V, et al. J Crohns Colitis. 2018 Apr 27;12(5):631. doi: 10.1093/ecco-jcc/jjx171. J Crohns Colitis. 2018. PMID: 29566131 No abstract available.

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.

Keywords: Crohn’s disease; clinical trials.

PubMed Disclaimer

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions

LinkOut - more resources

Full Text Sources
- Silverchair Information Systems
Other Literature Sources
- scite Smart Citations
Medical
- MedlinePlus Health Information

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Evolving Concepts in Phases I and II Drug Development for Crohn's Disease

Affiliations

Evolving Concepts in Phases I and II Drug Development for Crohn's Disease

Authors

Affiliations

Erratum in

Abstract

Publication types

MeSH terms

Substances

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical