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精准肿瘤学作为标准治疗范式在全系统应用中的挑战与解决方案

英文原题:Challenges and solutions to system-wide use of precision oncology as the standard of care paradigm.

查看英文原题

Challenges and solutions to system-wide use of precision oncology as the standard of care paradigm.

PubMed 2024/03/26(内容时间) Camb Prism Precis Med

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中文摘要

尽管基于基因组学识别可操作变异的技術进步,以及药物开发对这些特定靶点的日益关注,个性化肿瘤学范式在实施上仍面临挑战。为确保我们持续凝聚合力以改善所有癌症类型的结局,需要解决财务、技术和运营方面的障碍。例如,将“分子肿瘤委员会”完全整合并认证为“标准治疗”可确保统一的临床决策路径,既能对抗碎片化,也是研究环境内外循证实施的基础。

总体而言,整合式实施一直局限于特定(常见)癌症类型,且仅在大型癌症中心或小型区域网络内进行。在此,我们聚焦于基因组学、病理学、外科手术、肿瘤治疗、临床源系统数据以及全身影像数字化数据分析在真实世界整合中的解决方案,这些可促进成本效益分析、临床试验招募和结局评估。这一对癌症的紧迫要求还延伸至早期诊断和辅助治疗干预、个体化癌症疫苗、免疫细胞疗法、个性化合成致死疗法以及癌症筛查和预防。全球肿瘤诊疗系统需要在解决方案中实现前瞻性跨越式变革,包括可解决以患者为中心挑战的术中数字化工作模式,以确保包容、优质、可持续、公平且具有成本效益的采用和高效实施。

在此,我们强调阻碍精准肿瘤学大规模实施的人力、技术、临床、监管和经济挑战,并提供基于最低限度必要数字工具的标准化诊疗综合解决方案的系统路线图。这些包括统一决策支持工具、质量控制、在伦理和法律数据框架内的数据流动、培训与认证、监测与反馈。弥合技术、运营、监管和经济差距需要公共和行业利益相关者在国家和全球范围内采取联合行动。

展开英文摘要原文

The personalised oncology paradigm remains challenging to deliver despite technological advances in genomics-based identification of actionable variants combined with the increasing focus of drug development on these specific targets. To ensure we continue to build concerted momentum to improve outcomes across all cancer types, financial, technological and operational barriers need to be addressed.

For example, complete integration and certification of the 'molecular tumour board' into 'standard of care' ensures a unified clinical decision pathway that both counteracts fragmentation and is the cornerstone of evidence-based delivery inside and outside of a research setting. Generally, integrated delivery has been restricted to specific (common) cancer types either within major cancer centres or small regional networks.

Here, we focus on solutions in real-world integration of genomics, pathology, surgery, oncological treatments, data from clinical source systems and analysis of whole-body imaging as digital data that can facilitate cost-effectiveness analysis, clinical trial recruitment, and outcome assessment.

This urgent imperative for cancer also extends across the early diagnosis and adjuvant treatment interventions, individualised cancer vaccines, immune cell therapies, personalised synthetic lethal therapeutics and cancer screening and prevention. Oncology care systems worldwide require proactive step-changes in solutions that include inter-operative digital working that can solve patient centred challenges to ensure inclusive, quality, sustainable, fair and cost-effective adoption and efficient delivery.

Here we highlight workforce, technical, clinical, regulatory and economic challenges that prevent the implementation of precision oncology at scale, and offer a systematic roadmap of integrated solutions for standard of care based on minimal essential digital tools.

These include unified decision support tools, quality control, data flows within an ethical and legal data framework, training and certification, monitoring and feedback. Bridging the technical, operational, regulatory and economic gaps demands the joint actions from public and industry stakeholders across national and global boundaries.

论文信息

作者
Lajmi N、Alves-Vasconcelos S、Tsiachristas A、Haworth A、Woods K、Crichton C、Noble T、Salih H
第一作者单位
Diagnostics Division, Roche Information Solutions, F. Hoffmann-La Roche Ltd., Basel, Switzerland.Switzerland
通讯作者单位
Oxford Molecular Pathology Institute, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK.United Kingdom
文献类型
综述
期刊
Cambridge prisms. Precision medicine2024
原文标识
PubMed 38699518 · DOI 10.1017/pcm.2024.1