Background Fibrotic interstitial lung diseases (fILDs) are a heterogeneous group of lung diseases associated with significant morbidity and mortality. Despite a large increase in the number of clinical trials in the last 10 years, current regulatory-approved management approaches are limited to two therapies that prevent the progression of fibrosis. The drug development pipeline is long and there is an urgent need to accelerate this process. This manuscript introduces the concept and design of an innovative research approach to drug development in fILD: a global Randomised Embedded Multifactorial Adaptive Platform in fILD (REMAP-ILD). Methods Description of the REMAP-ILD concept and design: the specific terminology, design characteristics (multifactorial, adaptive features, statistical approach), target population, interventions, outcomes, mission and values, and organisational structure. Results The target population will be adult patients with fILD, and the primary outcome will be a disease progression model incorporating forced vital capacity and mortality over 12 months. Responsive adaptive randomisation, prespecified thresholds for success and futility will be used to assess the effectiveness and safety of interventions. REMAP-ILD embraces the core values of diversity, equity, and inclusion for patients and researchers, and prioritises an open-science approach to data sharing and dissemination of results. Conclusion By using an innovative and efficient adaptive multi-interventional trial platform design, we aim to accelerate and improve care for patients with fILD. Through worldwide collaboration, novel analytical methodology and pragmatic trial delivery, REMAP-ILD aims to overcome major limitations associated with conventional randomised controlled trial approaches to rapidly improve the care of people living with fILD.

中文翻译：

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自适应多介入试验平台可改善纤维化间质性肺疾病患者的护理

背景纤维化间质性肺疾病（fILD）是一组异质性肺部疾病，与显着的发病率和死亡率相关。尽管过去 10 年临床试验数量大幅增加，但目前监管部门批准的管理方法仅限于两种预防纤维化进展的疗法。药物开发渠道漫长，迫切需要加快这一进程。本手稿介绍了 fILD 药物开发创新研究方法的概念和设计：fILD 中的全球随机嵌入式多因素自适应平台（REMAP-ILD）。方法 REMAP-ILD 概念和设计的描述：具体术语、设计特征（多因素、适应性特征、统计方法）、目标人群、干预措施、结果、使命和价值观以及组织结构。结果 目标人群将是成年 fILD 患者，主要结果将是包含 12 个月内用力肺活量和死亡率的疾病进展模型。将使用响应适应性随机化、预先设定的成功和无效阈值来评估干预措施的有效性和安全性。REMAP-ILD 秉承患者和研究人员的多样性、公平性和包容性的核心价值观，并优先考虑采用开放科学方法来共享数据和传播结果。结论 通过使用创新且高效的适应性多干预试验平台设计，我们的目标是加速和改善对 fILD 患者的护理。通过全球合作、新颖的分析方法和务实的试验实施，REMAP-ILD 旨在克服与传统随机对照试验方法相关的主要局限性，以快速改善 fILD 患者的护理。