The Future of Clinical Trials in Inflammatory Bowel Disease

被引：5
作者：
Ma, Christopher [1 ,2 ,3 ]
Solitano, Virginia [4 ,5 ]
Danese, Silvio [5 ]
Jairath, Vipul [3 ,4 ,6 ]
机构：
[1] Univ Calgary, Dept Med, Div Gastroenterol & Hepatol, Calgary, AB, Canada
[2] Univ Calgary, Dept Community Hlth Sci, 6D61 Cal Wenzel Precis Hlth Bldg,3280 Hosp Drive N, Calgary T2N 4Z6, AB, Canada
[3] Alimentiv Inc, London, ON, Canada
[4] Western Univ, Dept Med, Div Gastroenterol, London, ON, Canada
[5] Univ Vita Salute San Raffaele, IRCCS Osped San Raffaele, Div Gastroenterol & Gastrointestinal Endoscopy, Milan, Italy
[6] Western Univ, Dept Epidemiol & Biostat, London, ON, Canada
来源：
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY | 2025年 / 23卷 / 03期
关键词：
Controlled; Crohn's Disease; Randomized; Trials; Ulcerative Colitis; ACTIVE ULCERATIVE-COLITIS; REPORTED OUTCOME MEASURES; ELEVATE UC 52; CROHNS-DISEASE; MAINTENANCE THERAPY; POPULATION PHARMACOKINETICS; RETROSPECTIVE ANALYSIS; BIOLOGICAL THERAPIES; INDUCTION THERAPY; DOUBLE-BLIND;
D O I：
10.1016/j.cgh.2024.06.036
中图分类号：
R57 [消化系及腹部疾病];
学科分类号：
摘要：
The medical management of inflammatory bowel disease (IBD) has been transformed over the past few decades by the approval of multiple classes of advanced therapies and the integration of more targeted treatment strategies for Crohn's disease and ulcerative colitis. These changes have been driven by an increasing number of pivotal randomized controlled trials, which have grown in size and complexity over time. Several landmark studies that are anticipated to change current IBD management paradigms have recently been completed or are on-going, including the first head-to-head biologic trials, advanced combination treatment trials, therapeutic strategy and treatment target trials, and multiple phase 3 registrational programs of novel compounds. Despite these advances, the future of IBD trials also faces major challenges with respect to cost, feasibility, and recruitment. Accordingly, innovative methods for early and late phase randomized controlled trials must be adopted. In this review, we provide a comprehensive overview of the evolution of modern IBD trials, discuss methods for improving trial efficiency in early and late phase development, and provide insights into the interpretation and implications of these data for clinical care.
引用
收藏
页码：480 / 489
页数：10
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