Declining Enrolment and Other Challenges in IBD Clinical Trials: Causes and Potential Solutions

Area of Science:

• Gastroenterology
• Clinical Research
• Drug Development

Background:

• Declining enrollment rates in inflammatory bowel disease (IBD) clinical trials are causing significant delays and increasing costs.
• This trend hinders the development of novel therapeutic strategies for IBD patients.

Purpose of the Study:

• To identify and analyze the primary bottlenecks hindering patient enrollment in IBD clinical trials.
• To propose actionable solutions to improve recruitment and retention in IBD studies.

Main Methods:

• A taskforce of IBD clinical trial experts from academia and industry was assembled.
• Barriers to enrollment were systematically evaluated across four key levels: study design, investigative center, physician, and patient.

Main Results:

• Key challenges include complex trial demands, high screen failure rates (especially in Crohn's disease), and misaligned assessment tools.
• Restrictive eligibility criteria, excessive procedures, and administrative burdens further impede progress.
• Physician time constraints and inadequate training, alongside patient-related factors like long washout periods and impractical treatment protocols, significantly limit participation.

Conclusions:

• The identified barriers necessitate a collaborative transformation involving research centers, sponsors, and regulatory bodies.
• Implementing proposed solutions can revitalize IBD clinical trial enrollment and accelerate the delivery of innovative treatments.