Heterogeneity in Definitions of Efficacy and Safety Endpoints for Clinical Trials of Crohn’s Disease: A Systematic Review

Author:

Ma ChristopherORCID,Hussein Isra M.,Al-Abbar Yousef J.,Panaccione Remo,Fedorak Richard N.,Parker Claire E.,Nguyen Tran M.,Khanna Reena,Siegel Corey A.,Peyrin-Biroulet Laurent,Pai Rish K.,Vande Casteele NielsORCID,D’Haens Geert R.,Sandborn William J.,Feagan Brian G.,Jairath Vipul

Publisher

Elsevier BV

Subject

Gastroenterology,Hepatology

Reference145 articles.

1. Evolving concepts in phases I and II drug development for Crohn's disease;Jairath;J Crohns Colitis,2017

2. Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE): determining therapeutic goals for treat-to-target;Peyrin-Biroulet;Am J Gastroenterol,2015

3. United States Food and Drug Administration. Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims 2009. Available from: https://www.fda.gov/downloads/drugs/guidances/ucm193282.pdf. Accessed December 15, 2017.

4. Patient-reported outcomes as primary end points in clinical trials of inflammatory bowel disease;Williet;Clin Gastroenterol Hepatol,2014

5. Development and validation of an endoscopic index of the severity for Crohn's disease: a prospective multicentre study—Groupe d'Etudes Therapeutiques des Affections Inflammatoires du Tube Digestif (GETAID);Mary;Gut,1989

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