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.

中文翻译：

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炎症性肠病临床试验的未来


在过去的几十年里，炎症性肠病 （IBD） 的医疗管理已经发生了变化，因为多类先进疗法的批准以及针对克罗恩病和溃疡性结肠炎的更有针对性的治疗策略的整合。这些变化是由越来越多的关键随机对照试验推动的，随着时间的推移，这些试验的规模和复杂性都在增加。几项有望改变当前 IBD 管理模式的里程碑式研究最近已经完成或正在进行中，包括首次头对头生物试验、高级联合治疗试验、治疗策略和治疗靶点试验，以及新化合物的多个 3 期注册项目。尽管取得了这些进步，但 IBD 试验的未来在成本、可行性和招募方面也面临重大挑战。因此，必须采用早期和晚期随机对照试验的创新方法。在这篇综述中，我们全面概述了现代 IBD 试验的演变，讨论了在早期和晚期开发中提高试验效率的方法，并提供了对这些数据对临床护理的解释和影响的见解。