Recommendations for Standardizing Clinical Trial Design and Endoscopic Assessment in Postoperative Crohn's Disease.

ABSTRACT:

Background

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.

Methods

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.

Results

Inclusion of patients with a history of completely resected ileocolonic CD in regulatory clinical t

SUBMITTER: Hanzel J 

PROVIDER: S-EPMC9756946 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature