Expert recommendations to standardize transcriptomic analysis in inflammatory bowel disease clinical trials

Area of Science:

• Genomics and Molecular Biology
• Gastroenterology
• Translational Research

Background:

• Transcriptomic data in inflammatory bowel disease (IBD) studies suffer from significant methodological and reporting inconsistencies.
• This heterogeneity hinders the interpretation and generalizability of findings from IBD transcriptomic research.
• Standardization is needed to enhance the value of transcriptomic data in clinical trials.

Purpose of the Study:

• To develop expert recommendations for standardizing transcriptomic research in inflammatory bowel disease (IBD) clinical trials.
• To address and overcome existing methodological discrepancies in IBD transcriptomic studies.
• To foster the inclusion of standardized transcriptomic research in clinical development.

Main Methods:

• A systematic review identified 37 reports of transcriptomic analyses in IBD clinical trials using global RNA assay platforms.
• A modified R&D/UCLA appropriateness methodology process and expert surveys were used to develop and rate recommendations.
• 16 IBD translational researchers and gastroenterologists participated in two rounds of appropriateness ratings.

Main Results:

• The systematic review identified substantial heterogeneity in study design, methodology, and reporting.
• Expert panels rated 75% of 305 statements as appropriate for standardizing transcriptomic research in IBD.
• Recommendations were generated for sample size, biopsy handling, and data analysis/reporting.

Conclusions:

• Methodological heterogeneity remains a challenge for transcriptomic research in IBD.
• Expert-driven recommendations aim to standardize transcriptomic studies in IBD clinical trials.
• Implementation of these recommendations will improve data quality and clinical utility.