Access to treatment-guiding biomarkers in the UK: surveys of cancer patients and healthcare professionals

To understand current barriers to treatment-guiding biomarker testing in cancer patients in the UK. A literature search, interviews with healthcare professionals, and a focus group of cancer patients were used to identify current challenges and barriers to treatment guiding biomarker testing. These were followed by online surveys of healthcare professionals and patients designed to further explore and quantify challenges to biomarker testing within the UK. Challenges were identified across the entire biomarker testing pathway, the most common being insufficient workforce, long turnaround times, and lack of specific training. These challenges had a negative impact on patient access to targeted cancer therapies. Challenges to accessing treatment-guiding biomarker testing of cancer patients within the UK are impacting clinical decision-making. There is a requirement to improve awareness and training of healthcare professionals, particularly nurses and advanced clinical practitioners, with opportunities to improve outdated and fragmented ordering and reporting processes. Steps should also be taken to improve the availability of plain-language information materials for patients, to promote understanding and self-advocacy. <b>Why did we perform this research?</b> To identify the best treatment options for cancer patients, it is important to test the patient’s tumor for the presence of specific genetic variants or proteins (also known as biomarkers). Previous publications have suggested that many UK patients do not receive such tests, even when NHS guidelines state they should. This research aimed to understand what proportion of patients are not getting tested, and why biomarker testing is not occurring in all patients. <b>What did we do?</b> Patients and healthcare professionals, including oncologists, nurses, and lab scientists, were interviewed and/or surveyed to identify any barriers in the NHS to treatment-guiding biomarker testing. <b>What were the results?</b> In total, 47.5% of the cancer patients stated they had not received treatment guiding-biomarker tests or were unsure if they had received such tests. NHS professionals told us that there were many challenges to implementing biomarker testing, the most common being insufficient staffing levels and lack of tailored training about genetic and biomarker testing, particularly among nurses. Also, test results took too long, with more than half of patients waiting longer than the recommended 2 weeks for a test result. <b>What are the implications?</b> Our findings indicate that broad reforms and additional resources are needed within the NHS to ensure cancer patients have access to the right treatments.

本研究旨在探究英国癌症患者接受治疗指导型生物标志物（biomarker）检测当前面临的障碍。
研究通过文献检索、访谈医疗保健专业人员，以及开展癌症患者焦点小组讨论，明确了治疗指导型生物标志物检测当前面临的各类挑战与障碍。随后，研究针对英国医疗保健专业人员与患者开展线上问卷调查，以进一步探究并量化该国生物标志物检测面临的挑战。
生物标志物检测全流程均存在各类挑战，其中最普遍的问题包括医护人力配置不足、检测结果周转周期过长，以及缺乏针对性专项培训。此类挑战对患者获取靶向癌症治疗方案造成了负面影响。英国癌症患者在获取治疗指导型生物标志物检测过程中面临的障碍，正对临床决策造成干扰。因此，亟需提升医疗保健专业人员的认知水平与实操能力，尤其是护士与高级临床执业者；同时需优化陈旧且碎片化的检测申请与报告流程。此外，还应完善面向患者的通俗化科普资料供给，以助力患者充分理解检测流程并提升自我参与与维权意识。

**研究开展缘由**
为明确癌症患者的最佳治疗方案，需对患者肿瘤组织进行检测，以确定是否存在特定基因变异或蛋白质（即生物标志物）。既往研究显示，即便英国国民保健服务（National Health Service, NHS）指南推荐需开展此类检测，仍有大量英国患者未能接受相应检测。本研究旨在明确未接受检测的患者比例，以及为何并非所有患者都能获得治疗指导型生物标志物检测。

**研究方法**
研究通过访谈与问卷调查的方式，纳入癌症患者及肿瘤科医师、护士、实验室科研人员等医疗保健专业人员，以识别英国国民保健服务体系内阻碍治疗指导型生物标志物检测开展的各类因素。

**研究结果**
总计47.5%的癌症患者表示自身未接受治疗指导型生物标志物检测，或不确定是否接受过此类检测。英国国民保健服务的从业人员反馈，生物标志物检测的落地实施面临诸多挑战，其中最普遍的问题为医护人力配置不足，以及缺乏针对基因与生物标志物检测的定制化专项培训，尤以护士群体的培训缺口最为显著。此外，检测结果出具耗时过长，超半数患者等待检测结果的时长超出推荐的2周标准。

**研究启示**
本研究结果表明，英国国民保健服务体系亟需开展全面改革并补充相关资源，以确保癌症患者能够获得适配的个体化治疗方案。