Most adults with moderate-to-severe ulcerative colitis may be ineligible for randomized controlled trials
More than half of real-world adult patients with moderate-to-severe ulcerative colitis (UC) are ineligible for current randomized controlled trials (RCTs), according to a study published online Aug. 4 in Crohn's & Colitis 360.
A study published in Crohn's & Colitis 360 on August 4 reveals that most adults with moderate-to-severe ulcerative colitis may be ineligible for current randomized controlled trials (RCTs). Researchers from Mayo Clinic Arizona analyzed data from 150 patients seen between January and February 2023. According to inclusion and exclusion criteria from seven phase 3 RCTs conducted between 2012 and 2022, only 42.7% of the patients met the eligibility requirements for at least one of the trials.
The most common exclusion factors were current or prior medication use, anemia, dysplasia, and the extent of disease. Interestingly, the researchers found no significant difference in trial eligibility based on age, gender, or disease duration. Despite this finding, the authors note that there is still significant potential to broaden patient participation in RCTs.
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