A new international Delphi consensus led by valuable researchers provides crucial guidance on the design and endpoints of clinical trials for Acute Severe Ulcerative Colitis (ASUC). This comprehensive consensus, developed with input from global experts, establishes 30 key statements that define essential aspects of ASUC trial design.
The consensus outlines eligibility criteria that focus on accurately defining patient inclusion based on disease severity, prior therapies, and diagnostic markers. It provides clear recommendations on trial design, including strategies for randomization, corticosteroid management, and patient stratification to ensure robust and unbiased results. Furthermore, the document specifies therapeutic endpoints, offering precise definitions of clinical response, remission, and patient-reported outcomes, all critical for evaluating the efficacy of new treatments.
With ASUC posing significant risks, including high colectomy and mortality rates, these guidelines aim to elevate the quality of clinical research, support effective drug development, and ultimately improve patient outcomes. For clinicians, researchers, and stakeholders in gastroenterology, this consensus represents a pivotal step toward standardized, high-quality ASUC trials.
