ArticleJournal of Crohn's & colitis2025
Comparison of the FDA and EMA guidance on drug development in ulcerative colitis: an expert panel review.
Article in Journal of Crohn's & colitis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Placebo rates in randomized clinical trials of ulcerative colitis: an individual patient data meta-analysis.Journal of Crohn's & colitis · 2025Pooled it
- Optimising clinical trial design choices in inflammatory bowel disease.BMJ open gastroenterology · 2026Review
- Biological and Targeted Therapies in the Multidisciplinary Management of Gastrointestinal Cancers.Cancers · 2026Review
- Induction and Prolonged Induction With Mirikizumab in Ulcerative Colitis-A Prospective, Real-World Study From the Sicilian Network for Inflammatory Bowel Disease (SN-IBD).United European gastroenterology journal · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimsThe Food and Drug Administration (FDA) and European Medicines Agency (EMA) ensure the safety, efficacy, and security of treatments, including therapies for immune-mediated disorders such as inflammatory bowel disease (IBD). Their clinical trial guidelines aid sponsors in designing robust studies. While the EMA updated its guidelines for ulcerative colitis (UC) in 2018, the FDA issued new recommendations in April 2022. This paper compares these guidelines, assesses their implications for IBD clinical trials, and proposes strategies to improve alignment and trial efficiency.
methodsA comparative analysis of the FDA's 2022 guidelines and the EMA's 2018 guidelines for UC clinical trials was conducted. Key elements reviewed include trial population criteria, study design, assessment tools, endpoints, and safety considerations. Recommendations for optimization were developed in consultation with an expert panel.
resultsThe FDA's 2022 updates emphasize balanced participant representation, the use of full colonoscopy for endoscopic severity assessment, and introduce "maintenance of remission" as a new concept. Other novelties include updated statistical guidance and stricter safety requirements. While these updates enhance trial robustness, they also pose challenges for implementation.
conclusionsHarmonizing FDA and EMA guidelines is essential to streamline global IBD clinical trials, reduce redundancies, and improve patient outcomes. Recommendations include adopting less invasive assessments, standardizing remission definitions, and prioritizing patient-centered endpoints. These measures could reduce trial complexity, increase inclusivity, and accelerate the development of effective therapies for UC.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.