The management of gastrointestinal tract diseases, especially inflammatory bowel disease (IBD), has been transformed over the past few decades. This has been made possible by the approval of new classes of advanced therapies and the integration of more targeted treatment strategies for Crohn’s disease (CD) and Ulcerative Colitis (UC).
Despite these advances, IBD trials remain challenging in their operational complexity, feasibility, and recruitment, with enrolment rates being alarmingly low: from 1998 to 2020, the average enrolment rate in moderate to severe UC trials decreased from 0.32 to 0.12 patients per site per month. For CD, the average recruitment rate also decreased, from 0.65 to less than 0.08 patients per site per month.
What are the specific challenges of IBD clinical research, and how can we develop randomized trial strategies for inflammatory gastrointestinal diseases that are more attractive to patients? How can clinical trials industry stakeholders enhance the overall efficiency of gastrointestinal clinical research?
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