Wellcome-HRB Clinical Research Facility at St James's Hospital Dublin, Dublin, Ireland.
Trinity College Dublin, Dublin, Ireland.
Regen Med. 2024;19(7-8):439-444. doi: 10.1080/17460751.2024.2368352. Epub 2024 Jul 16.
Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer groundbreaking new opportunities for the treatment of disease and injury. However, ATMP adoption requires adjustments to current clinical practices and frameworks. This study investigates the readiness of the Irish healthcare system to adopt licensed ATMPs. Scoping review, guided by the preferred reporting items for systematic reviews and meta-analyses - scoping review extension. A systematic search of English articles from 2013 to 2023 (published and grey literature) will be conducted. Findings will be presented via narrative summary, graphical and tabular formats. Review findings will be discussed in the context of recommendations that will inform national policy and strategy on the adoption of ATMPs in Ireland.
先进治疗药物产品(ATMPs)是基于基因、组织或细胞的人类用药物。它们为疾病和损伤的治疗提供了开创性的新机会。然而,ATMP 的采用需要对当前的临床实践和框架进行调整。本研究调查了爱尔兰医疗保健系统采用许可的 ATMP 的准备情况。 以系统评价和荟萃分析的首选报告项目为指导的范围审查扩展。将对 2013 年至 2023 年(已发表和灰色文献)的英语文章进行系统搜索。研究结果将通过叙述性摘要、图形和表格格式呈现。将根据建议讨论审查结果,这些建议将为爱尔兰采用 ATMP 提供国家政策和战略信息。