Literature DB >> 27487793

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

Vipul Jairath1,2,3, Barrett G Levesque2,4, Niels Vande Casteele2,4,5, Reena Khanna1,2, Mahmoud Mosli6, Pieter Hindryckx2,7, Simon Travis3, Marjolijn Duijvestein8, Jordi Rimola9, Julian Panes9, Geert D'Haens2,8, William J Sandborn2,4, Brian G Feagan10,2,11.   

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.
Copyright © 2016 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Entities:  

Keywords:  Crohn’s disease; clinical trials

Mesh：

Substances：

Year:  2016        PMID： 27487793     DOI： 10.1093/ecco-jcc/jjw137

Source DB:  PubMed          Journal:  J Crohns Colitis        ISSN： 1873-9946            Impact factor:   9.071


  6 in total

1.  An expert consensus to standardise definitions, diagnosis and treatment targets for anti-fibrotic stricture therapies in Crohn's disease.

Authors:  F Rieder; D Bettenworth; C Ma; C E Parker; L A Williamson; S A Nelson; G van Assche; A Di Sabatino; Y Bouhnik; R W Stidham; A Dignass; G Rogler; S A Taylor; J Stoker; J Rimola; M E Baker; J G Fletcher; J Panes; W J Sandborn; B G Feagan; V Jairath
Journal:  Aliment Pharmacol Ther       Date:  2018-06-19       Impact factor: 8.171

Review 2.  Evolution of Clinical Trials in Inflammatory Bowel Diseases.

Authors:  Siddharth Singh
Journal:  Curr Gastroenterol Rep       Date:  2018-08-04

3.  Development of a core outcome set for clinical trials in inflammatory bowel disease: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

Authors:  Christopher Ma; Remo Panaccione; Richard N Fedorak; Claire E Parker; Reena Khanna; Barrett G Levesque; William J Sandborn; Brian G Feagan; Vipul Jairath
Journal:  BMJ Open       Date:  2017-06-09       Impact factor: 2.692

Review 4.  Differentiation of fibrotic and inflammatory component of Crohn's disease-associated strictures.

Authors:  Jordi Rimola; Nunzia Capozzi
Journal:  Intest Res       Date:  2020-04-20

5.  Development of the symptoms and impacts questionnaire for Crohn's disease and ulcerative colitis.

Authors:  Parambir S Dulai; Vipul Jairath; Reena Khanna; Christopher Ma; Kelly P McCarrier; Mona L Martin; Claire E Parker; Joan Morris; Brian G Feagan; William J Sandborn
Journal:  Aliment Pharmacol Ther       Date:  2020-04-21       Impact factor: 8.171

6.  A Dynamic Quantitative Systems Pharmacology Model of Inflammatory Bowel Disease: Part 2 - Application to Current Therapies in Crohn's Disease.

Authors:  Katharine V Rogers; Steven W Martin; Indranil Bhattacharya; Ravi Shankar Prasad Singh; Satyaprakash Nayak
Journal:  Clin Transl Sci       Date:  2020-08-21       Impact factor: 4.689
  6 in total

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