Nanomedicines have created a paradigm shift in healthcare. Yet fundamental barriers still exist that prevent or delay the clinical translation of nanomedicines. Critical hurdles inhibiting clinical success include poor understanding of nanomedicines’ physicochemical properties, limited exposure in the cell or tissue of interest, poor reproducibility of preclinical outcomes in clinical trials, and biocompatibility concerns. Barriers that delay translation include industrial scale-up or scale-down and good manufacturing practices, funding and navigating the regulatory environment. Here we propose the DELIVER framework comprising the core principles to be realized during preclinical development to promote clinical investigation of nanomedicines. The proposed framework comes with design, experimental, manufacturing, preclinical, clinical, regulatory and business considerations, which we recommend investigators to carefully review during early-stage nanomedicine design and development to mitigate risk and enable timely clinical success. By reducing development time and clinical trial failure, it is envisaged that this framework will help accelerate the clinical translation and maximize the impact of nanomedicines.

纳米药物在医疗保健领域创造了范式转变。然而，仍然存在阻止或延迟纳米药物临床转化的根本障碍。阻碍临床成功的关键障碍包括对纳米药物的物理化学特性了解不足、在感兴趣的细胞或组织中的暴露有限、临床试验中临床前结果的可重复性差以及生物相容性问题。延迟翻译的障碍包括工业规模扩大或缩小规模和良好生产规范、资金和驾驭监管环境。在这里，我们提出了 DELIVER 框架，该框架包含在临床前开发过程中要实现的核心原则，以促进纳米药物的临床研究。拟议的框架包括设计、实验、制造、临床前、临床、监管和商业考虑，我们建议研究人员在早期纳米药物设计和开发期间仔细审查，以降低风险并及时获得临床成功。通过减少开发时间和临床试验失败，预计该框架将有助于加速临床转化并最大限度地发挥纳米药物的影响。