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Discrepancies in the therapeutic indications granted by the European Medicines Agency and the US Food and Drug Administration for new cancer drugs: An analysis of potential explanations 欧洲药品管理局和美国食品和药物管理局对新的癌症药物批准的治疗适应症的差异:对潜在解释的分析。
IF 2 Q3 HEALTH POLICY & SERVICES Pub Date : 2025-11-05 DOI: 10.1016/j.jcpo.2025.100660
Allan Cramer , Freja Karuna Hemmingsen Sørup , Hanne Rolighed Christensen , Kristian Karstoft , Tonny Studsgaard Petersen

Background

Studies have found notable differences between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in indications granted to new cancer drugs (e.g., different treatment lines). It is unknown why they occur; therefore, we aimed to analyse if maturity of data or characteristics of the pivotal trials might be explanations.

Methods

New cancer drugs approved by both EMA and the FDA in the study period between January 1, 2020, to December 31, 2022, and new cancer drugs that were approved by one agency in the study period and at the other agency outside the study period were included in the analysis. The drugs were identified by searching the FDA and EMA websites.

Results

A total of 36 new cancer drugs were included. Notable differences between EMA and the FDA in the granted indication were found in 15 (42 %) of the drugs. The proportion of cancer drugs with differences in maturity of data at time of assessment between EMA and the FDA was similar for drugs with and without notable differences in the indication. Furthermore, the results did not indicate that low level of evidence (e.g., early phase trial as the pivotal, single-arm design, or use of surrogate endpoints) was more common in the cancer drugs with notable differences in the indication.

Conclusion

The frequent discrepancies in the granted indications between EMA and the FDA for new cancer drugs during a three year period could not be explained by maturity of data at time of assessment or characteristics of the pivotal trials. Therefore, divergence in regulatory policies between the two agencies is considered a more likely explanation.

Policy summary

Discrepancies between regulatory agencies in the indications granted to new cancer drugs suggest a problematic extrapolation and thus uncertainty regarding the clinical benefit for the patients. The present study seeks to identify potential explanations for the discrepancies to reduce the misalignment in the future.
背景:研究发现欧洲药品管理局(EMA)和美国食品和药物管理局(FDA)在授予新癌症药物的适应症方面存在显着差异。这些差异导致了用药物治疗的患者临床获益的不确定性。目前尚不清楚它们发生的原因;因此,我们的目的是分析数据的成熟度或关键试验的特征是否可以解释。方法:所有在2020年1月1日至2022年12月31日期间获得EMA和FDA批准并至少在其中一个机构做出最终决定的抗癌新药都被纳入分析。这些药物是通过搜索FDA和EMA网站确定的。结果:共纳入36种抗癌新药。EMA和FDA在15种(42%)药物的批准适应症上存在显著差异。EMA通常比FDA有更成熟的数据,但在比较有无显著差异的药物时,比例相似。此外,结果并没有表明低水平的证据(例如,早期试验作为关键,单臂设计,或使用替代终点)在癌症药物中更常见,在适应症上有显著差异。结论:EMA和FDA在抗癌新药批准适应症上的频繁差异不能用评估时数据的成熟度或关键试验的特点来解释。因此,两个机构之间监管政策的分歧被认为是一个更可能的解释。政策总结:监管机构之间对新癌症药物适应症的差异表明外推有问题,因此对患者的临床益处不确定。本研究旨在找出这些差异的潜在解释,以减少未来的偏差。
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引用次数: 0
Enhancing multidisciplinary oncology care: Feasibility of structured tools for Belgian multidisciplinary oncological consultation meetings 加强多学科肿瘤护理:比利时多学科肿瘤会诊会议结构化工具的可行性。
IF 2 Q3 HEALTH POLICY & SERVICES Pub Date : 2025-10-28 DOI: 10.1016/j.jcpo.2025.100656
Nadine Boesten , Melissa De Regge , Hannes Vanpoecke , Mark Leys , Kristof Eeckloo , Paul Gemmel

Background

Multidisciplinary team meetings (MDTMs) are considered a cornerstone of oncology care, yet questions remain about their efficiency and patient-centeredness. While tools exist to guide and structure MDTMs, their integration into hospital settings is often inconsistent.

Methods

This feasibility study examined the use of two validated tools—the MDT-QuIC checklist and the MDT-MeDiC complexity tool—across ten Multidisciplinary Oncological Consultations (MOCs) in five Belgian hospitals. Baseline assessments were conducted using the validated MDT-MODe observational instrument. Implementation feasibility was evaluated through repeated observations at the MOCs and interviews with MOC chairs.

Results

Baseline data showed limited discussion of psychosocial information and patient preferences, and minimal nurse contribution. The MDT-QuIC was generally accepted as helpful for structure and role clarity, though not consistently applied due to time pressures. The MDT-MeDiC tool was considered too resource-intensive for routine use. Implementation success varied by existing structure, leadership style, and administrative support.

Conclusion

Structured tools can improve the organization of MOCs, but feasibility is dependent on local context. Broader uptake across health systems requires attention to team composition, preparatory workflows, and integration into supportive policy and digital frameworks.

Policy summary

Embedding structured MDTM tools into oncology policy, through digital integration, case complexity triaging, and incentives for psychosocial and nursing input enables efficient use of expert time while safeguarding patient-centredness.
背景:多学科团队会议(MDTMs)被认为是肿瘤治疗的基石,但其效率和以患者为中心的问题仍然存在。虽然存在指导和构建mdtm的工具,但它们在医院环境中的整合往往不一致。方法:本可行性研究检查了两种有效工具- MDT-QuIC检查表和MDT-MeDiC复杂性工具-在比利时五家医院的10个多学科肿瘤会诊(moc)中的使用。基线评估使用经过验证的MDT-MODe观测仪器进行。通过在MOC的反复观察和与MOC主席的访谈,评估了实施的可行性。结果:基线数据显示对心理社会信息和患者偏好的讨论有限,护士的贡献最小。MDT-QuIC被普遍接受为有助于结构和角色清晰度,尽管由于时间压力而没有一直应用。MDT-MeDiC工具被认为是常规使用的资源密集型工具。实施的成功取决于现有的结构、领导风格和行政支持。结论:结构化工具可以改善moc的组织,但其可行性取决于当地情况。在整个卫生系统中更广泛地采用需要注意团队组成、准备工作流程以及将其纳入支持性政策和数字框架。政策摘要:通过数字化整合、病例复杂性分诊以及对心理社会和护理投入的激励,将结构化MDTM工具嵌入肿瘤学政策,可以有效利用专家时间,同时保障以患者为中心。
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引用次数: 0
Global emerging trends and correlation of financial toxicity in cancer care: A bibliographic review (2013–2024) 癌症治疗中金融毒性的全球新趋势和相关性:文献回顾(2013-2024)。
IF 2 Q3 HEALTH POLICY & SERVICES Pub Date : 2025-10-28 DOI: 10.1016/j.jcpo.2025.100658
Xiaojun Zhang , Shixiang Chen , Yuting Feng , Hailing Ren , Yanwen Zhang , Ying Chen , Bingxin Ma , Jin Yang , Yaogang Wang , Qi Lu , Yue Zhao

Purpose

Financial toxicity has garnered increasing attention due to the financial “toxic effect” of cancer therapy. This study was conducted to provide an overall research landscape on financial toxicity from chronological, geographical, socioeconomic and epidemiological perspectives.

Designs

Publications on financial toxicity were retrieved from the Web of Science Core Collection. IBM SPSS 26.0 was used to analyze the correlation between the number of publications and socioeconomic and epidemiological factors. VOSviewer, CiteSpace, Scimago Graphica and Pajek were used for country/region collaboration, reference cocitation, keyword cooccurrence, and keyword burst analysis.

Results

Between 2013 and 2024, 501 publications were identified, with the number of publications increasing annually. The annual number of publications was highly positively correlated with the annual cancer incidence rate, prevalence rate, death rate, and disability-adjusted life years (R2 = 0.907, 0.820, 0.836, 0.808, respectively). The number of publications in different countries was highly positively correlated with total health spending, government health spending, and out-of-pocket health spending (R2 = 0.955, 0.906, 0.746, respectively). The top journal was Supportive Care in Cancer (79 publications). Research hotspots focus on the impact of financial toxicity on quality of life and psychological distress, the measurement and cost burden of financial toxicity, its impact on health outcomes, and the employment and health impact of financial toxicity. Research frontiers focused on the financial stress and young adult.

Conclusions

The increasing number of publications on financial toxicity highlights its growing recognition as an important issue in healthcare. Health professionals and governments should address the high costs of cancer care and explore interventions to reduce its impact on patients and healthcare spending.
目的:由于癌症治疗的财务“毒性效应”,财务毒性已引起越来越多的关注。本研究旨在从时间、地理、社会经济和流行病学的角度对金融毒性进行全面的研究。设计:从Web of Science核心馆藏中检索有关金融毒性的出版物。采用IBM SPSS 26.0分析发表论文数量与社会经济和流行病学因素的相关性。使用VOSviewer、CiteSpace、Scimago Graphica和Pajek进行国家/地区协作、参考文献检索、关键词协同和关键词突发分析。结果:2013 - 2024年共鉴定出501篇文献,文献数量呈逐年增加趋势。年发表数与年癌症发病率、患病率、死亡率、伤残调整生命年呈高度正相关(R2分别为0.907、0.820、0.836、0.808)。不同国家的出版物数量与总卫生支出、政府卫生支出和自费卫生支出呈高度正相关(R2分别= 0.955、0.906、0.746)。排名第一的期刊是《癌症支持治疗》(79篇)。研究热点主要集中在财务毒性对生活质量和心理困扰的影响、财务毒性的测量和成本负担、财务毒性对健康结果的影响、财务毒性对就业和健康的影响等方面。研究前沿集中在经济压力与年轻人。结论:越来越多的出版物对财务毒性突出其日益认识到作为一个重要的问题,在医疗保健。卫生专业人员和政府应解决癌症护理的高成本问题,并探索干预措施,以减少其对患者和医疗保健支出的影响。
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引用次数: 0
Areca nut-related oral cancer awareness in adults: A meta-analysis 成人槟榔相关口腔癌认知:一项荟萃分析
IF 2 Q3 HEALTH POLICY & SERVICES Pub Date : 2025-10-28 DOI: 10.1016/j.jcpo.2025.100649
Nathaniel Wu , Thomas J. Roberts , Nikki Apana , Sanjena Venkatesh , Nicole Deville , Eric Pineda , Song Zhang , Mona Pathak , Kekoa Taparra , William J. Moss

Background

Areca nut is classified as a Group I carcinogen for oral cavity malignancies by the International Agency for Research on Cancer. Cultivation of the substance and oral cancer incidences have risen considerably in recent years. The assessment of areca nut-related health risk awareness is an increasingly imperative global health topic.

Methods

A systematic review of the Medline, Web of Science, Embase and Cochrane databases was undertaken in search of prospective survey studies evaluating areca nut-related health literacy in adults. The primary outcome of interest was the percentage of respondents that were unaware that areca nut products cause oral cancer. A random effects meta-analysis was used to calculate pooled weighted averages. Subgroup analyses stratifying by healthcare education level, geography and publication year were performed using a Chi-square test.

Results

Twenty-eight articles with a total of 13,440 respondents were included in the analysis. Collectively, 50 % (95 % CI: 40 %-60 %, I2 99·5 %) of respondents did not identify areca nut products in general as a risk factor for oral cancer. Only five studies specifically inquired about the carcinogenicity of areca nut without additives. Collectively, 80 % (95 % CI: 63 %-96 %, I2 99·3 %) of these respondents did not know that pure areca nut is a carcinogen. There were no significant discrepancies on subgroup analyses by healthcare education level, geography or date of publication.

Conclusion

An international collection of evidence substantiates drastic areca nut-related health literacy deficiencies internationally.

Policy Summary

There is an urgent need for healthcare professionals in areca nut regions to launch formalized educational campaigns. Medically-accurate, culturally-sensitive warning labels are strongly indicated.
背景:槟榔果被国际癌症研究机构列为口腔恶性肿瘤的一类致癌物。近年来,该物质的种植和口腔癌的发病率大幅上升。槟榔相关的健康风险意识评估是一个日益迫切的全球健康话题。方法:对Medline、Web of Science、Embase和Cochrane数据库进行系统回顾,寻找评估成人槟榔相关健康素养的前瞻性调查研究。研究的主要结果是受访者中不知道槟榔果产品会导致口腔癌的百分比。随机效应荟萃分析用于计算合并加权平均值。采用卡方检验对按卫生教育水平、地理位置和出版年份进行分层的亚组分析。结果:共纳入28篇文章,13440名被调查者。总的来说,50% (95% CI: 40%-60%, i995%)的受访者一般不认为槟榔果制品是口腔癌的危险因素。只有五项研究专门询问了不含添加剂的槟榔果的致癌性。总的来说,这些受访者中有80% (95% CI: 63%-96%, i299.3%)不知道纯槟榔是致癌物。在亚组分析中,卫生保健教育水平、地理位置和发表日期没有显著差异。结论:一项国际证据收集证实了国际上与槟榔相关的健康素养严重不足。政策摘要:槟榔果地区迫切需要保健专业人员开展正式的教育运动。强烈建议使用医学上准确、文化上敏感的警告标签。
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引用次数: 0
Investigational sites requirements according to trial complexity and intervention level under EU Regulation No. 536/2014 根据欧盟第536/2014号法规的试验复杂性和干预水平,研究地点要求
IF 2 Q3 HEALTH POLICY & SERVICES Pub Date : 2025-10-25 DOI: 10.1016/j.jcpo.2025.100655
Celeste Cagnazzo , Evaristo Maiello , Roberto Labianca , Valeria Facciolo , Francesco Perrone , Gennaro Daniele , Massimo Di Maio , Carmine Pinto
The full implementation of Regulation (EU) No. 536/2014 has transformed the European clinical research landscape, introducing a harmonised, risk-based framework for trial approval and conduct. In Italy, however, the lack of nationally standardised site suitability criteria beyond phase I trials remains a critical regulatory gap, leading to procedural inconsistencies, delayed activations, and unequal patient access. This paper examines the shortcomings in European and Italian regulations and operations and suggests a tiered framework of minimum requirements for investigational centres. The model adjusts requirements based on trial complexity and associated risk, while ensuring compliance with EU legislation. This approach supports wider participation in pragmatic and late-phase oncology trials and prevents excessive centralisation in a few key hubs. It also emphasizes the need for formal recognition of essential research roles, such as study coordinators, data managers, and research pharmacists, critical to high-quality trials. By adopting this risk-adapted, scalable approach, national authorities could improve site qualification, streamline trial timelines, and enhance Italy’s competitiveness in international oncology research. From a policy standpoint, establishing proportionate national standards is urgent to ensure equitable patient access, strengthen the resilience of the research system, and align with the inclusive and risk-oriented spirit of Regulation (EU) No. 536/2014.

Policy summary

Italy lacks nationally standardised site suitability criteria beyond phase I clinical trials, causing delays and inequities. This paper proposes a risk-based, proportionate framework of minimum requirements for investigational sites, aligned with Regulation (EU) No. 536/2014. Adoption by AIFA would provide consistent benchmarks for Ethics Committees and sponsors, improve trial activation, and expand equitable access to innovative therapies, while reinforcing Italy’s role in multinational oncology research.
法规(EU) No 536/2014的全面实施改变了欧洲临床研究的格局,引入了一个统一的、基于风险的试验批准和实施框架。然而,在意大利,在I期试验之后缺乏全国标准化的地点适用性标准仍然是一个关键的监管缺口,导致程序不一致、延迟激活和患者获取不平等。本文考察了欧洲和意大利法规和操作的缺点,并提出了调查中心最低要求的分层框架。该模型根据试验的复杂性和相关风险调整要求,同时确保符合欧盟立法。这种方法支持更广泛地参与实用和晚期肿瘤试验,并防止在几个关键中心过度集中。它还强调需要正式承认重要的研究角色,如研究协调员、数据管理人员和研究药剂师,他们对高质量的试验至关重要。通过采用这种适应风险、可扩展的方法,国家当局可以改善地点资格,简化试验时间表,并提高意大利在国际肿瘤学研究中的竞争力。从政策角度来看,迫切需要制定相应的国家标准,以确保患者公平获得,加强研究系统的复原力,并与(EU)第536/2014号条例的包容性和风险导向精神保持一致。政策总结:意大利在I期临床试验之外缺乏全国标准化的地点适宜性标准,导致延迟和不公平。本文提出了一个基于风险的、比例的研究场所最低要求框架,与法规(EU) 536/2014保持一致。AIFA的采纳将为伦理委员会和赞助商提供一致的基准,改善试验激活,扩大创新疗法的公平获取,同时加强意大利在多国肿瘤研究中的作用。
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引用次数: 0
Bridging the equity gap in colorectal cancer screening: A comparative analysis across high-income countries 弥合结直肠癌筛查的公平差距:高收入国家的比较分析
IF 2 Q3 HEALTH POLICY & SERVICES Pub Date : 2025-10-23 DOI: 10.1016/j.jcpo.2025.100657
Yasmin Jahan , Atiqur SM-Rahman

Background

Despite the availability of colorectal cancer (CRC) screening programs in high-income countries (HICs), disparities in access and outcomes persist. Equity-focused policies are essential to ensure that CRC prevention reaches all population groups, particularly those underserved or marginalized.

Methods

We conducted a comparative policy analysis of CRC screening systems across ten HICs using peer-reviewed literature, national cancer agency reports, and updated screening data. Two summary tables were developed: one detailing screening modalities, coverage rates, and intervals; the other outlining equity-focused policies, gaps, and country-specific recommendations.

Results

The analysis revealed substantial variation in screening modalities and coverage rates, with organized, population-based programs generally achieving higher uptake. Equity-focused policies varied widely, with common gaps including limited outreach in rural areas, under-screening among minority populations, and insufficient equity data collection. Recommendations included expanding culturally tailored education, improving data systems, and embedding equity metrics into national strategies.

Conclusion

This study contributes to the growing evidence base on health equity in cancer prevention by offering a replicable framework for cross-country policy benchmarking. The findings underscore the importance of integrating equity into CRC screening programs to reduce disparities and improve outcomes across diverse health systems.
背景:尽管高收入国家(HICs)有结直肠癌(CRC)筛查项目,但在可及性和结果方面的差异仍然存在。以公平为重点的政策对于确保所有人群,特别是服务不足或边缘化人群都能预防儿童CRC至关重要。方法:我们使用同行评议文献、国家癌症机构报告和更新的筛查数据,对10个高收入国家的CRC筛查系统进行了比较政策分析。开发了两个汇总表:一个详细列出了筛查方式、覆盖率和间隔;另一份概述了以公平为重点的政策、差距和具体国家的建议。结果分析显示,筛查方式和覆盖率存在很大差异,有组织的、以人群为基础的项目通常具有较高的采用率。以公平为重点的政策差异很大,普遍存在差距,包括农村地区的推广范围有限,少数民族人口的筛查不足,以及公平数据收集不足。建议包括扩大适合不同文化的教育,改进数据系统,以及将公平指标纳入国家战略。本研究通过为跨国政策基准制定提供可复制的框架,为癌症预防卫生公平提供了越来越多的证据基础。研究结果强调了将公平纳入结直肠癌筛查计划的重要性,以减少不同卫生系统之间的差异并改善结果。
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引用次数: 0
Australia’s cancer crossroads: Prevention, innovation, and equity as policy imperatives 澳大利亚的癌症十字路口:预防、创新和公平政策势在必行
IF 2 Q3 HEALTH POLICY & SERVICES Pub Date : 2025-10-22 DOI: 10.1016/j.jcpo.2025.100654
Rashidul Alam Mahumud
Cancer in Australia represents a paradox: survival outcomes are among the best globally, yet incidence remains high, inequities persist, and costs are rising. In 2025, ∼170,000 new cases are projected nationally, with age-standardised mortality estimated at ∼194 deaths per 100,000, declining over three decades yet still representing a substantial absolute burden. The most common diagnosed cancers, breast, prostate, colorectal, melanoma, and lung, reflect both demographic ageing and improved detection, as well as preventable risk factors and structural gaps in early detection and care. Lung cancer remains the leading cause of death, underscoring the importance of Australia’s National Lung Cancer Screening Program, which commenced on 1 July 2025 to provide targeted low-dose CT screening for high-risk populations. We argue that Australia’s cancer system is at a crossroads: policy must strengthen prevention, embed equity, and sustain innovation simultaneously. Priorities include scaling effective prevention, ensuring equitable participation in population and targeted screening (including the new lung program), improving timely diagnostic pathways, expanding fair access to evidence-based therapies, and investing in survivorship and supportive care. Without explicit equity safeguards and value-based principles, rising incidence and high-cost therapies risk undermining sustainability. The Australian experience offers important lessons for other high-income countries balancing progress with equity in cancer control. We emphasise data-driven improvement, including the public reporting of stage, diagnostic timeliness, treatment, outcomes, and out-of-pocket (OOP) costs stratified by geography, socioeconomic status, and Indigenous status, to reduce unwarranted variation and improve health equity; forthcoming programs (e.g., lung screening; risk-stratified melanoma) should be designed for equity from inception. Although survival has improved, high incidence, driven by population ageing, detection practices, and modifiable risks, persists; inequities and rising costs also persist. Outcomes and equity are tightly linked to early detection, through screening and timely diagnostic pathways for symptomatic patients, because delays in time-to-diagnosis drive avoidable advanced-stage presentation and poorer survival. Screening participation remains suboptimal and inequitable; in breast cancer, incomplete capture of privately obtained mammography outside BreastScreen can obscure true participation among higher-income groups. Addressing prevention, diagnostic timeliness, and unwarranted variation is essential to improve outcomes, equity, and value. Australia’s rising cancer burden reflects demographic ageing and detection practices, compounded by preventable risk factors and inequities in timely diagnosis and care; policy responses should integrate prevention with diagnostic timeliness, equitable access, and value-based investment.
澳大利亚的癌症代表了一个悖论:生存结果是全球最好的,但发病率仍然很高,不平等现象持续存在,成本不断上升。到2025年,预计全国将出现约170,000例新病例,年龄标准化死亡率估计为每100,000例约194例死亡,在三十年中下降,但仍然是一个巨大的绝对负担。最常见的诊断癌症,即乳腺癌、前列腺癌、结直肠癌、黑色素瘤和肺癌,反映了人口老龄化和检测的改善,以及可预防的风险因素和早期检测和护理方面的结构性差距。肺癌仍然是导致死亡的主要原因,这凸显了澳大利亚国家肺癌筛查方案的重要性,该方案于2025年7月1日启动,为高危人群提供有针对性的低剂量CT筛查。我们认为,澳大利亚的癌症系统正处于十字路口:政策必须同时加强预防、嵌入公平和保持创新。优先事项包括扩大有效预防规模,确保人群公平参与和有针对性的筛查(包括新的肺部项目),改善及时诊断途径,扩大公平获得循证治疗的机会,以及投资于幸存者和支持性护理。如果没有明确的公平保障和基于价值的原则,发病率上升和高成本疗法可能会破坏可持续性。澳大利亚的经验为其他高收入国家在癌症控制方面平衡进步与公平提供了重要的教训。我们强调数据驱动的改进,包括公开报告阶段、诊断及时性、治疗、结果和按地理、社会经济地位和土著地位分层的自付费用(OOP),以减少不必要的差异并改善卫生公平;即将开展的项目(如肺部筛查、风险分层黑色素瘤)从一开始就应考虑公平性。尽管生存率有所提高,但由于人口老龄化、检测方法和可改变的风险,高发病率仍然存在;不平等和成本上升也依然存在。结果和公平与通过筛查和及时诊断途径对有症状患者进行早期发现密切相关,因为诊断时间的延误会导致本可避免的晚期症状和较差的生存期。筛查参与仍然是次优和不公平的;在乳腺癌方面,在乳房筛查之外不完全获取私人获得的乳房x光检查可能会模糊高收入群体的真实参与情况。解决预防、诊断及时性和不必要的变化问题对于改善结果、公平性和价值至关重要。澳大利亚不断上升的癌症负担反映了人口老龄化和检测实践,加上可预防的风险因素和及时诊断和护理方面的不平等;政策应对应将预防与诊断及时性、公平获取和基于价值的投资结合起来。
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引用次数: 0
Lessons learned from the support of the International Atomic Energy Agency, International Agency for Research on Cancer and World Health Organization to develop National Cancer Control Plans in low- and middle-income countries. 国际原子能机构、国际癌症研究机构和世界卫生组织支持中低收入国家制定国家癌症控制计划的经验教训。
IF 2 Q3 HEALTH POLICY & SERVICES Pub Date : 2025-10-21 DOI: 10.1016/j.jcpo.2025.100652
Lisa Montel, John Russell, Issimouha Dille Mahamadou, Mary Nyangasi, Sharon Katai Kapambwe, Alfred Karagu Maina, Valerian Mwenda, Andre Carvalho, Geraldine Arias de Göbl, Marianna Nobile, Yannick Romero, Mauricio Maza, Lisa M Stevens

Background: The International Atomic Energy Agency (IAEA), International Agency for Research on Cancer (IARC) and World Health Organization (WHO) assist countries in building and strengthening their cancer control capacity. This support includes guidance to Member States to set priorities for national cancer control through the development and implementation of National Cancer Control Plans (NCCPs). Our aim was to identify the lessons learned from the support United Nations (UN) agencies provide to develop NCCPs in low- and middle-income countries (LMICs) to support the development of guidance.

Methods: We developed a questionnaire based on a review of the NCCP literature and conducted semi-structured interviews with 11 Member States that received UN agency support between 2020 and 2023 and five IAEA Programme Officers who coordinated UN support. We coded the transcripts inductively and performed a thematic analysis of the data.

Results: Three main themes were identified, each with their own barriers and enablers to develop NCCPs: coordination of NCCP development; method; and governance. We discuss each of these challenges and offer recommendations for Member States and UN agencies to further improve the development process of national cancer control strategies. We selected Kenya as a case study to show an example of good practice.

Conclusion: This paper complements a sister study conducted by the International Cancer Control Partnership which assessed challenges of developing NCCPs for countries that received a different type of support. Both studies contribute to the growing body of NCCP literature following the 2025 global review of NCCPs.

Policy summary: The lessons learned from the IAEA-IARC-WHO support to develop NCCPs will inform policies, programmes and practices in cancer control planning and implementation in LMICs, as well as the development of a common methodology for UN agencies to provide NCCP support.

背景:国际原子能机构(原子能机构)、国际癌症研究机构(癌症研究机构)和世界卫生组织(卫生组织)协助各国建立和加强其癌症控制能力。这种支持包括指导会员国通过制定和实施国家癌症控制计划来确定国家癌症控制的优先事项。我们的目的是确定从联合国机构为中低收入国家制定国家核心方案提供的支持中吸取的经验教训,以支持指南的制定。方法:我们在回顾NCCP文献的基础上编制了一份问卷,并对11个在2020年至2023年期间接受联合国机构支持的成员国和5名协调联合国支持的原子能机构项目官员进行了半结构化访谈。我们对转录本进行了归纳编码,并对数据进行了专题分析。结果:确定了三个主要主题,每个主题都有各自的障碍和推动因素来制定国家重点控制方案:国家重点控制方案发展的协调;方法;和治理。我们讨论了每一项挑战,并为会员国和联合国机构提出建议,以进一步改善国家癌症控制战略的制定进程。我们选择肯尼亚作为案例研究,以展示良好实践的例子。结论:本文对国际癌症控制伙伴关系开展的一项姊妹研究进行了补充,该研究评估了获得不同类型支持的国家发展非核心控制方案的挑战。在2025年全球NCCP回顾之后,这两项研究都为NCCP文献的增长做出了贡献。政策摘要:从国际原子能机构-国际癌症研究机构-世卫组织支持制定国家重点控制项目中吸取的经验教训将为中低收入国家癌症控制规划和实施方面的政策、规划和做法提供参考,并为联合国机构提供国家重点控制项目支持制定共同方法。
{"title":"Lessons learned from the support of the International Atomic Energy Agency, International Agency for Research on Cancer and World Health Organization to develop National Cancer Control Plans in low- and middle-income countries.","authors":"Lisa Montel, John Russell, Issimouha Dille Mahamadou, Mary Nyangasi, Sharon Katai Kapambwe, Alfred Karagu Maina, Valerian Mwenda, Andre Carvalho, Geraldine Arias de Göbl, Marianna Nobile, Yannick Romero, Mauricio Maza, Lisa M Stevens","doi":"10.1016/j.jcpo.2025.100652","DOIUrl":"10.1016/j.jcpo.2025.100652","url":null,"abstract":"<p><strong>Background: </strong>The International Atomic Energy Agency (IAEA), International Agency for Research on Cancer (IARC) and World Health Organization (WHO) assist countries in building and strengthening their cancer control capacity. This support includes guidance to Member States to set priorities for national cancer control through the development and implementation of National Cancer Control Plans (NCCPs). Our aim was to identify the lessons learned from the support United Nations (UN) agencies provide to develop NCCPs in low- and middle-income countries (LMICs) to support the development of guidance.</p><p><strong>Methods: </strong>We developed a questionnaire based on a review of the NCCP literature and conducted semi-structured interviews with 11 Member States that received UN agency support between 2020 and 2023 and five IAEA Programme Officers who coordinated UN support. We coded the transcripts inductively and performed a thematic analysis of the data.</p><p><strong>Results: </strong>Three main themes were identified, each with their own barriers and enablers to develop NCCPs: coordination of NCCP development; method; and governance. We discuss each of these challenges and offer recommendations for Member States and UN agencies to further improve the development process of national cancer control strategies. We selected Kenya as a case study to show an example of good practice.</p><p><strong>Conclusion: </strong>This paper complements a sister study conducted by the International Cancer Control Partnership which assessed challenges of developing NCCPs for countries that received a different type of support. Both studies contribute to the growing body of NCCP literature following the 2025 global review of NCCPs.</p><p><strong>Policy summary: </strong>The lessons learned from the IAEA-IARC-WHO support to develop NCCPs will inform policies, programmes and practices in cancer control planning and implementation in LMICs, as well as the development of a common methodology for UN agencies to provide NCCP support.</p>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":" ","pages":"100652"},"PeriodicalIF":2.0,"publicationDate":"2025-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145356399","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Overlooked and underreported: A systematic review of quality of life in recent Phase III metastatic breast cancer trials 被忽视和少报:最近III期转移性乳腺癌试验中生活质量的系统评价。
IF 2 Q3 HEALTH POLICY & SERVICES Pub Date : 2025-10-21 DOI: 10.1016/j.jcpo.2025.100653
Shreyas Kalantri , Chiranjeevi Sainatham , Jayanth Reddy Tallapalli , Pranali Pachika , Blake Kelley , Ranadheer Reddy Dande , Greeshma Gaddipati , Zhanxu Liu , Maiying Kong , Brian Dong , Elizabeth Riley

Background

In metastatic breast cancer (MBC), where treatment is non-curative, patient quality of life (QoL) is a critical consideration alongside traditional survival outcomes. Despite increasing recognition by regulatory bodies, the extent of QoL incorporation into contemporary Phase III trials remains unclear.

Methods

We conducted a systematic review of Phase III randomized controlled trials evaluating therapeutic interventions for MBC published between 2019 and 2023, using the PubMed database. Trials were categorized based on receptor subtype (HR+, HER2 +, TNBC), trial design (superiority vs. non-inferiority), study outcome (positive vs. negative), and journal impact factor. The primary outcome was the incorporation of QoL outcomes in published results.

Results

Among 122 eligible trials, only 36.9 % included QoL measures. Subgroup analysis revealed higher QoL incorporation in hormone receptor-positive trials compared to HER2 + and TNBC subtypes. Non-inferiority trials were more likely to include QoL endpoints (50 %) than superiority trials (33.7 %). QoL reporting was higher in negative studies (45 %) compared to positive studies (33 %), with no significant difference based on journal impact factor.

Conclusion

Despite regulatory emphasis on patient-centered outcomes, QoL assessments remain underreported in publications of Phase III MBC trials. Standardized incorporation of QoL metrics is essential to better capture the holistic impact of therapies, improve clinical decision-making, and align oncologic research with patient priorities.
背景:在转移性乳腺癌(MBC)中,治疗无法治愈,患者的生活质量(QoL)与传统的生存结果一样是一个关键的考虑因素。尽管越来越多的监管机构认识到,生活质量纳入当代III期试验的程度仍不清楚。方法:我们使用PubMed数据库,对2019年至2023年间发表的评估MBC治疗干预措施的III期随机对照试验进行了系统回顾。根据受体亚型(HR+、HER2+、TNBC)、试验设计(优势与非劣效性)、研究结果(阳性与阴性)和期刊影响因子对试验进行分类。主要结局是在已发表的结果中纳入生活质量结局。结果:在122个符合条件的试验中,仅36.9%纳入了生活质量测量。亚组分析显示,与HER2+和TNBC亚型相比,激素受体阳性患者的生活质量掺入率更高。非劣效性试验(50%)比优效性试验(33.7%)更可能包括生活质量终点。负面研究的生活质量报告(45%)高于正面研究(33%),基于期刊影响因子无显著差异。结论:尽管监管机构强调以患者为中心的结果,但在发表的三期MBC试验中,生活质量评估仍然被低估。生活质量指标的标准化整合对于更好地捕捉治疗的整体影响、改善临床决策以及使肿瘤研究与患者优先事项保持一致至关重要。
{"title":"Overlooked and underreported: A systematic review of quality of life in recent Phase III metastatic breast cancer trials","authors":"Shreyas Kalantri ,&nbsp;Chiranjeevi Sainatham ,&nbsp;Jayanth Reddy Tallapalli ,&nbsp;Pranali Pachika ,&nbsp;Blake Kelley ,&nbsp;Ranadheer Reddy Dande ,&nbsp;Greeshma Gaddipati ,&nbsp;Zhanxu Liu ,&nbsp;Maiying Kong ,&nbsp;Brian Dong ,&nbsp;Elizabeth Riley","doi":"10.1016/j.jcpo.2025.100653","DOIUrl":"10.1016/j.jcpo.2025.100653","url":null,"abstract":"<div><h3>Background</h3><div>In metastatic breast cancer (MBC), where treatment is non-curative, patient quality of life (QoL) is a critical consideration alongside traditional survival outcomes. Despite increasing recognition by regulatory bodies, the extent of QoL incorporation into contemporary Phase III trials remains unclear.</div></div><div><h3>Methods</h3><div>We conducted a systematic review of Phase III randomized controlled trials evaluating therapeutic interventions for MBC published between 2019 and 2023, using the PubMed database. Trials were categorized based on receptor subtype (HR+, HER2 +, TNBC), trial design (superiority vs. non-inferiority), study outcome (positive vs. negative), and journal impact factor. The primary outcome was the incorporation of QoL outcomes in published results.</div></div><div><h3>Results</h3><div>Among 122 eligible trials, only 36.9 % included QoL measures. Subgroup analysis revealed higher QoL incorporation in hormone receptor-positive trials compared to HER2 + and TNBC subtypes. Non-inferiority trials were more likely to include QoL endpoints (50 %) than superiority trials (33.7 %). QoL reporting was higher in negative studies (45 %) compared to positive studies (33 %), with no significant difference based on journal impact factor.</div></div><div><h3>Conclusion</h3><div>Despite regulatory emphasis on patient-centered outcomes, QoL assessments remain underreported in publications of Phase III MBC trials. Standardized incorporation of QoL metrics is essential to better capture the holistic impact of therapies, improve clinical decision-making, and align oncologic research with patient priorities.</div></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"46 ","pages":"Article 100653"},"PeriodicalIF":2.0,"publicationDate":"2025-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145356331","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Organizing contemporary oncology care together – A scoping review on multi-hospital oncology networks 共同组织当代肿瘤护理——多医院肿瘤网络的范围审查。
IF 2 Q3 HEALTH POLICY & SERVICES Pub Date : 2025-10-16 DOI: 10.1016/j.jcpo.2025.100651
Roos van der Ven , Daan Westra , Felice van Erning , Ignace de Hingh , Aggie Paulus , on behalf of the OncoZON consortium

Introduction

In oncology, hospitals increasingly collaborate in multi-hospital networks to deliver high-quality care. However, it is unclear how these networks should be organized and whether they are effective.

Methods

Following PRISMA-ScR guidelines, this scoping review included peer-reviewed studies on multi-hospital oncology networks of three or more autonomous hospitals collaborating to deliver services and improve quality of care in high income economies, published in English.

Results

The search yielded 4.013 hits, of which 47 articles were included. Results revealed that the research field is relatively young, remains in part descriptive, and is highly fragmented, leaving questions about the optimal organization of multi-hospital networks. Although multi-hospital networks exhibit similar, centralized structural features, they vary in the way they are governed. Furthermore, although network outcomes are generally positive, studies predominantly focus on process-outcomes rather than patient-outcomes and often suffer from methodological flaws.

Policy summary

Insights from this review can be used by clinicians and hospital leaders to enhance their chances of network success, and by researchers as a guide for future studies. Multi-hospital oncology networks are increasingly organized, often as centralized hub-and-spoke models. To ensure these networks truly benefit patients, policies could support balanced collaboration between expert and non-expert centers, strengthen joint decision-making, and focus on patient outcomes rather than only process improvements. Further research on these networks is needed to better inform policy. This requires shared terminology, strengthened study designs, and integration of insights across fields.

Registry Name and Number

This review is pre-registered at Open Science Framework (blinded for peer review).
在肿瘤学领域,医院越来越多地在多医院网络中合作,以提供高质量的护理。然而,目前尚不清楚这些网络应该如何组织,以及它们是否有效。方法:遵循PRISMA-ScR指南,本范围审查纳入了同行评议的研究,这些研究涉及高收入经济体中三家或更多自主医院合作提供服务和提高护理质量的多医院肿瘤网络,并以英文发表。结果:检索结果为4.013条,其中包含47篇文章。结果表明,研究领域是相对年轻的,仍然是部分描述性的,是高度碎片化的,留下关于多医院网络的最佳组织的问题。尽管多医院网络表现出类似的集中结构特征,但它们在管理方式上有所不同。此外,尽管网络结果通常是积极的,但研究主要关注过程结果而不是患者结果,并且经常存在方法上的缺陷。政策总结:本综述的见解可被临床医生和医院领导用于提高其网络成功的机会,并被研究人员用作未来研究的指南。多医院肿瘤网络越来越有组织,通常是集中的中心辐射模式。为了确保这些网络真正使患者受益,政策可以支持专家和非专家中心之间的平衡合作,加强联合决策,并关注患者的结果,而不仅仅是过程改进。需要对这些网络进行进一步研究,以便更好地为政策提供信息。这需要共享术语,加强研究设计,并整合跨领域的见解。注册中心名称和编号:本综述已在开放科学框架(Open Science Framework)预注册(盲标同行评审)。
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引用次数: 0
期刊
Journal of Cancer Policy
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