Review article: randomised controlled trials in inflammatory bowel disease-common challenges and potential solutions

Area of Science:

• Gastroenterology
• Clinical Trial Management
• Patient Recruitment

Background:

• Recruitment rates for Crohn's disease and ulcerative colitis clinical trials are declining.
• This impacts the inflammatory bowel disease (IBD) community and patient access to novel therapies.
• Urgent action is needed to improve IBD trial enrollment.

Purpose of the Study:

• Identify challenges contributing to decreased recruitment in IBD clinical trials.
• Propose actionable solutions to enhance patient enrollment in these studies.

Main Methods:

• Literature review using PubMed and Google.
• Analysis of regulatory guidelines and conference proceedings.
• Extracted data from the Trialtrove database for IBD trials (1989-2020).

Main Results:

• Patient-centric study design is crucial, including improved documentation readability and patient involvement in planning.
• Minimizing placebo exposure through methods like platform trials is recommended.
• Reducing patient burden via non-invasive methods and streamlining administrative processes (e.g., electronic signatures) is vital.
• Adapting trial conduct, as seen during the COVID-19 pandemic, offers valuable lessons.

Conclusions:

• The IBD community must address multifaceted issues in clinical trial conduct to improve recruitment.
• Implementing proposed solutions can enhance enrollment for Crohn's disease and ulcerative colitis trials.
• Improving trial efficiency and patient experience is essential for advancing IBD treatment.