As CFTR modulator therapy transforms the landscape of cystic fibrosis (CF) care, its lack of uniform access across the globe combined with the shift towards a new standard of care creates unique challenges for the development of future CF therapies. The advancement of a full and promising CF therapeutics pipeline remains a necessary priority to ensure maximal clinical benefits for all people with CF. It is through collaboration across the global CF community that we can optimize the evaluation and approval process of new therapies. To this end, we must identify areas for which harmonization is lacking and for which efficiencies can be gained to promote ethical, feasible, and credible study designs amidst the changing CF care landscape. This article summarizes the counsel from core advisors across multiple international regions and clinical trial networks, developed during a one-day workshop in October 2019. The goal of the workshop was to identify, in consideration of the highly transitional era of CFTR modulator availability, the drug development areas for which global alignment is currently uncertain, and paths forward that will enable advancement of CF therapeutic development.

中文翻译：

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在过渡性 cftr 调节剂时代为 cf 疗法制定全球发展战略

随着 CFTR 调节剂疗法改变了囊性纤维化 (CF) 护理的格局，它在全球范围内缺乏统一的可及性，再加上向新护理标准的转变，为未来 CF 疗法的发展带来了独特的挑战。推进完整且有前景的 CF 治疗管道仍然是确保所有 CF 患者获得最大临床益处的必要优先事项。通过全球 CF 社区的合作，我们可以优化新疗法的评估和批准流程。为此，我们必须确定缺乏协调的领域，以及可以提高效率的领域，以在不断变化的 CF 护理环境中促进合乎道德、可行和可信的研究设计。