Abstract

The International Organization for the Study of Inflammatory Bowel Disease held a single-day meeting focused on challenges and opportunities in trial design. The meeting included 95 registrants and consisted of 2 plenary presentations and 3 breakout sessions. The overall goals of the meeting were to identify challenges that must be met in the design of clinical studies of new and established therapies for inflammatory bowel disease (IBD).

Highlights

  • Challenges and Opportunities in inflammatory bowel disease (IBD) Clinical Trial DesignDubinsky,[1] Rory Collins,[2,3] Maria T

  • Participants completed a survey focused on challenges in the conduct of clinical trials in inflammatory bowel disease (IBD)

  • These demands result in very complex protocols and have unintended negative consequences that include higher costs and longer times for completion of studies,[4,5] higher burden for patients,[6] fewer new treatments being developed by industry and fewer academic studies of current therapies, distortion of research agendas and reduced creative collaborations between academia and industry, and an undue focus on complying with rules rather than on innovation in the design and conduct of randomized controlled trials (RCTs)

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Summary

Challenges and Opportunities in IBD Clinical Trial Design

Dubinsky,[1] Rory Collins,[2,3] Maria T. Abreu,[4] on behalf of the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD). The International Organization for the Study of Inflammatory Bowel Disease held a single-day meeting focused on challenges and opportunities in trial design. The meeting included 95 registrants and consisted of 2 plenary presentations and 3 breakout sessions. The overall goals of the meeting were to identify challenges that must be met in the design of clinical studies of new and established therapies for inflammatory bowel disease (IBD)

Challenges in IBD Clinical Trials
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