Building sustainable IBD clinical research units: a practical toolbox emerging from a Belgian multi-stakeholder initiative.

IF 8.7
Ingrid Arijs, Leonie Govaerts, Lynn Debrun, Liselotte Fierens, Katleen Franc, Hilde Kelchtermans, Charlotte Minsart, Catherine Reenaers, Louise Vandenbroucke, Laura Vansteenkiste, Jolien De Rechter, Bram Verstockt
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Abstract

Clinical research is an essential pillar of modern inflammatory bowel disease (IBD) care, underpinning therapeutic innovation, biomarker discovery, precision medicine, and improvements in healthcare delivery. However, while international initiatives have successfully defined standards for clinical care, comparatively little attention has been devoted to the infrastructure required to conduct high-quality clinical research. Consequently, research capacity remains highly heterogeneous across centers, limiting patient access to clinical studies and reducing opportunities for collaborative research. To address this gap, a Belgian multi-stakeholder initiative involving patients, gastroenterologists, research nurses, study coordinators, and clinical researchers developed a practical toolbox for establishing and strengthening IBD clinical research units. Rather than defining rigid accreditation criteria, the toolbox distinguishes between essential components required for a functional research unit and important but non-essential elements that further improve quality, efficiency, and long-term sustainability. Structured across 3 complementary domains (administrative, operational, and collaborative) this framework provides a pragmatic roadmap that can support centers at different stages of research maturity. Beyond describing the toolbox, we discuss the concept of research readiness as a hallmark of excellence in modern IBD care and propose a roadmap for building sustainable research ecosystems. Although developed within the Belgian healthcare system, the principles presented are broadly applicable and may support the development of research capacity across healthcare systems and disease areas.

建设可持续的IBD临床研究单位:从比利时多方利益相关者倡议出现的实用工具箱。
临床研究是现代炎症性肠病(IBD)护理的重要支柱,是治疗创新、生物标志物发现、精准医学和改善医疗保健服务的基础。然而,虽然国际倡议已经成功地定义了临床护理标准,但对进行高质量临床研究所需的基础设施的关注相对较少。因此,各中心的研究能力仍然高度不均衡,限制了患者获得临床研究的机会,减少了合作研究的机会。为了弥补这一差距,比利时开展了一项涉及患者、胃肠病学家、研究护士、研究协调员和临床研究人员的多方利益相关者倡议,开发了一个实用工具箱,用于建立和加强IBD临床研究单位。工具箱不是定义严格的认证标准,而是区分功能性研究单位所需的基本组件和进一步提高质量、效率和长期可持续性的重要但非必要的组件。该框架跨越3个互补的领域(管理、运营和协作),提供了一个实用的路线图,可以支持处于不同研究成熟阶段的中心。除了描述工具箱之外,我们还讨论了研究准备作为现代IBD护理卓越标志的概念,并提出了构建可持续研究生态系统的路线图。虽然在比利时医疗保健系统内发展,提出的原则是广泛适用的,并可能支持跨医疗保健系统和疾病领域的研究能力的发展。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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