The Impact of Raising the Bar for Clinical Trials in Ulcerative Colitis.

ABSTRACT: In order to identify the practical implications for both health care practitioners and patients in understanding differences between the results of trials assessing therapies for ulcerative colitis [UC], we reviewed clinical trials of therapies for moderate to severe UC, with a focus on trial design. Over time, patient populations in UC trials have become more refractory, reflecting that patients are failing treatment with additional and different classes of drug, including conventional therapies, immunosuppressant drugs, and anti-tumour necrosis factor therapies. Outcomes used to measure efficacy have become increasingly stringent in order to meet the expectations of patients and physicians, and the requirements of regulatory bodies. Trial design has also evolved to integrate induction an

SUBMITTER: Sands BE 

PROVIDER: S-EPMC6821359 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature