Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/28052
Title: Recommendations for Standardizing Clinical Trial Design and Endoscopic Assessment in Postoperative Crohn's Disease.
Austin Authors: Hanzel, Jurij;Jairath, Vipul;De Cruz, Peter P ;Guizzetti, Leonardo;Shackelton, Lisa M;Bossuyt, Peter;Duijvestein, Marjolijn;Dulai, Parambir S;Grossmann, Johannes;Hirten, Robert P;Khanna, Reena;Panes, Julian;Peyrin-Biroulet, Laurent;Regueiro, Miguel;Rubin, David T;Singh, Siddharth;Stidham, Ryan W;Sandborn, William J;Feagan, Brian G;D'Haens, Geert R;Ma, Christopher
Affiliation: Medicine (University of Melbourne)
Department of Gastroenterology, UMC Ljubljana, Ljubljana, Slovenia
Alimentiv Inc., London, Ontario, Canada
Division of Gastroenterology, Western University, London, Ontario, Canada
Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada
Department of Internal Medicine, Division of Gastroenterology and Hepatology, University of Michigan Medical School, Ann Arbor, Michigan, USA
Department of Computational Medicine and Bioinformatics. University of Michigan Medical School, Ann Arbor, Michigan, USA
Division of Gastroenterology, University of California San Diego, La Jolla, California, USA
Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Alberta, Canada
Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Gastroenterology and Hepatology
Department of Gastroenterology, Imelda General Hospital, Bonheiden, Belgium
Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam Gastroenterology Endocrinology Metabolism (AGEM), University of Amsterdam, Amsterdam, the Netherlands
Division of Gastroenterology, University of California San Diego, La Jolla, California, USA
Department of Internal Medicine I, Bethesda Hospital, Johanniter GmbH, Mönchengladbach, Germany
Icahn School of Medicine, The Susan & Leonard Feinstein IBD Center Division of Gastroenterology, Mount Sinai, New York City, New York, USA
Division of Gastroenterology, Western University, London, Ontario, Canada
Hospital Clinic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain
Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine,Vandoeuvre-lès-Nancy, France
Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland, Ohio, USA
University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois, USA
Division of Gastroenterology, University of California San Diego, La Jolla, California, USA
Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam Gastroenterology Endocrinology Metabolism (AGEM), University of Amsterdam, Amsterdam, the Netherlands
Issue Date: 13-Nov-2021
Date: 2021-11-13
Publication information: Inflammatory Bowel Diseases 2021; online first: 13 November
Abstract: The lack of standardized methods for clinical trial design and disease activity assessment has contributed to an absence of approved medical therapies for the prevention of postoperative Crohn's disease (CD). We developed recommendations for regulatory trial design for this indication and for endoscopic assessment of postoperative CD activity. An international panel of 19 gastroenterologists was assembled. Modified Research and Development/University of California Los Angeles methodology was used to rate the appropriateness of 196 statements using a 9-point Likert scale in 2 rounds of voting. Results were reviewed and discussed between rounds. Inclusion of patients with a history of completely resected ileocolonic CD in regulatory clinical trials for the prevention of postoperative recurrence was appropriate. Given the absence of approved medical therapies, a placebo-controlled design with a primary end point of endoscopic remission at 52 weeks was appropriate for drug development for this indication; however, there was uncertainty regarding the appropriateness of a coprimary end point of symptomatic and endoscopic remission and the use of currently available patient-reported outcome measures. The modified Rutgeerts Score, endoscopic assessment of the anastomosis, and a minimum of 5cm of neoterminal ileum were also appropriate; although the appropriateness of other indices including the Simple Endoscopic Score for CD for endoscopic assessment of postoperative CD activity was uncertain. A framework for regulatory trial design for the prevention of postoperative CD recurrence and endoscopic assessment of disease activity has been developed. Research to empirically validate end points for these trials is needed.
URI: https://ahro.austin.org.au/austinjspui/handle/1/28052
DOI: 10.1093/ibd/izab259
ORCID: 0000-0003-3158-8014
0000-0001-8603-898X
0000-0003-4027-7365
0000-0002-8679-2541
0000-0002-4971-6902
0000-0002-7681-8111
0000-0002-4698-9948
Journal: Inflammatory Bowel Diseases
PubMed URL: 34791254
Type: Journal Article
Subjects: inflammatory bowel disease
medical therapy
randomized controlled trials
surgery
Appears in Collections:Journal articles

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