Princess Margaret Cancer Centre, University Health Network, 610 University Ave, Toronto, ON M5G 2M9, Canada.
Dalla Lana School of Public Health, University of Toronto, 155 College St, Toronto, ON M5T 3M7, Canada.
Curr Oncol. 2022 Sep 30;29(10):7257-7271. doi: 10.3390/curroncol29100572.
Canada's healthcare system, like others worldwide, is immersed in a process of evolution, attempting to adapt conventional frameworks of health technology assessment (HTA) and funding models to a new landscape of precision medicine in oncology. In particular, the need for real-world evidence in Canada is not matched by the necessary infrastructure and technologies required to integrate genomic and clinical data. Since healthcare systems in many developed nations face similar challenges, we adopted a solutions-based approach and conducted a search of worldwide programs in personalized medicine, with an emphasis on precision oncology. This search strategy included review articles published between 1 January 2016 and 1 March 2021 and hand-searches of their reference lists for relevant publications back to 1 December 2005. Thirty-nine initiatives across 37 countries in Europe, Australasia, Africa, and the Americas had the potential to lead to real-world data (RWD) on the clinical utility of oncology biomarkers. We highlight four initiatives with helpful lessons for Canada: Genomic Medicine France 2025, UNICANCER, the German Medical Informatics Initiative, and CANCER-ID. Among the 35 other programs evaluated, the main themes included the need for collaboration and systems to support data harmonization across multiple jurisdictions. In order to generate RWD in precision oncology that will prove acceptable to HTA bodies, Canada must take a national approach to biomarker strategy and unite all stakeholders at the highest level to overcome jurisdictional and technological barriers.
加拿大的医疗保健系统与世界其他国家一样，正处于不断发展和演变的过程中，试图将传统的健康技术评估（HTA）框架和资金模式应用于肿瘤精准医学的新领域。特别是，加拿大需要真实世界的数据，但目前缺乏整合基因组和临床数据所需的必要基础设施和技术。由于许多发达国家的医疗保健系统都面临着类似的挑战，我们采取了基于解决方案的方法，对个性化医学领域的全球项目进行了搜索，重点关注精准肿瘤学。这项搜索策略包括对 2016 年 1 月 1 日至 2021 年 3 月 1 日期间发表的综述文章进行了检索，并对这些文献的参考文献进行了手工检索，以获取截至 2005 年 12 月 1 日的相关出版物。在欧洲、澳大拉西亚、非洲和美洲的 37 个国家中，有 39 项举措有可能为肿瘤生物标志物的临床应用提供真实世界的数据（RWD）。我们重点介绍了加拿大有借鉴意义的四项举措：法国 2025 基因组医学、UNICANCER、德国医学信息学倡议和 CANCER-ID。在评估的 35 个其他项目中，主要主题包括需要合作和系统来支持跨多个司法管辖区的数据协调。为了在精准肿瘤学领域生成可被 HTA 机构接受的 RWD，加拿大必须采取国家层面的生物标志物策略，并将所有利益相关者联合起来，以克服司法和技术障碍。
