IBD Clinical Trials at a Crossroads (GI & Endoscopy News)

IBD clinical trials face growing challenges with recruitment and design. Patients often opt for approved therapies over trials with placebo arms or novel treatments, limiting participation. Dr. David Rubin of the University of Chicago emphasizes the need for more innovative, accessible trial designs, such as head-to-head comparisons and umbrella trials, to improve recruitment and efficacy evaluation.

Dr. Marla Dubinsky of Mount Sinai calls for more inclusive inclusion criteria, noting that real-world practices differ from clinical trial protocols, such as requiring long washout periods. She advocates for pediatric drug development to leverage adult data to accelerate approvals.
Experts, including Dr. Peter Higgins of the University of Michigan, propose using active comparators, such as biosimilars, over placebos to align trials more closely with clinical practice and improve patient outcomes. Moving away from placebo-controlled designs can reduce screen failures and offer more relevant insights for IBD care.