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Cross sectional analysis of long-term overall survival among patients taking immune checkpoint inhibitor drugs 服用免疫检查点抑制剂药物的患者长期总生存率的横断面分析。
IF 2 Q3 HEALTH POLICY & SERVICES Pub Date : 2025-11-19 DOI: 10.1016/j.jcpo.2025.100669
Alyson Haslam , Timothée Olivier , Vinay Prasad

Background

Immune checkpoint inhibitors (ICIs) have transformed the landscape of tumor therapy. Yet, little is known about the collective long-term survival from these therapies. We sought to characterize long-term survival.

Methods

In a cross-sectional analysis of US FDA oncology ICI drug approvals (2011–2023), we retrieved data from supporting registration trials. We examined the percentage of study participants surviving at 12-, 24-, 36-, and 60-months follow-up; the American Society of Clinical Oncology (ASCO) Value Framework Tail of the Curve calculation; and the correlation between the longest time with 10 % of patients still at-risk and the difference in the percentage of patients in each treatment group alive.

Results

Out of 88 included approvals, 20 (22.7 %) qualified for ASCO’s tail of the curve bonus. Twenty-seven studies (30.7 %) did not report OS at 12 months; 44 (50.0 %) did not report OS at 24 months; 60 (68.2 %) did not report OS at 36 months; and 78 (88.6 %) did not report OS at 60 months. We found no correlation between the last time that at least 10 % of patients were still at-risk and the difference in the percentage of patients in each group still alive at that time-point (R2=0.1; p = 0.30). Among 81 studies that reported an OS curve, the longest time with at least 10 % of participants at-risk was a median of 30 months. The median difference in survival was 8 %.

Conclusions

Few registration trials testing ICI oncology therapies report long-term overall survival data. The gathering and reporting of this information should be incentivized so that the value of these drugs for patients can be more readily assessed.
背景:免疫检查点抑制剂(ici)已经改变了肿瘤治疗的前景。然而,人们对这些疗法的集体长期生存率知之甚少。我们试图确定长期生存的特征。方法:在2011-2023年美国FDA肿瘤ICI药物批准的横断面分析中,我们检索了支持注册试验的数据。我们在随访12个月、24个月、36个月和60个月时检查了研究参与者的生存率;美国临床肿瘤学会(ASCO)价值框架曲线尾部计算;最长时间内仍有10%的患者处于危险中与每个治疗组中存活的患者百分比的差异之间的相关性。结果:20个批准(29.4%)符合ASCO曲线尾部奖励。27项研究(30.7%)在12个月时未报告OS;44例(50.0%)在24个月时未报告OS;60例(68.2%)在36个月时未报告OS;78例(88.6%)在60个月时未报告OS。我们发现,最后一次至少有10%的患者仍处于危险状态与两组患者在该时间点仍存活的患者百分比差异之间没有相关性(R2=0.1; p=0.30)。在报告OS曲线的81项研究中,至少有10%的参与者处于风险中的最长时间为中位数为30个月。中位生存差为8%。结论:很少有ICI肿瘤治疗的注册试验报告长期总生存数据。应该鼓励收集和报告这些信息,以便更容易地评估这些药物对患者的价值。
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引用次数: 0
Geographic distribution of CAR T-cell therapy clinical trials for childhood cancer: Scientific coherence and persistent needs 儿童癌症CAR - t细胞治疗临床试验的地理分布:科学一致性和持续需求。
IF 2 Q3 HEALTH POLICY & SERVICES Pub Date : 2025-11-17 DOI: 10.1016/j.jcpo.2025.100668
Fabriccio J. Visconti-Lopez , Johana Galvan-Barrios , Oscar Andrés Alzate Mejía , Foday Tejan Mansaray
This study aimed to evaluate the geographic distribution of Chimeric Antigen Receptor (CAR) T-cell therapy clinical trials for childhood cancer and assess their alignment with global health needs. Using a quantitative approach, we analyzed data on 317 clinical trials from the WHO’s Global Observatory on Health Research and Development (2007–2022) alongside global health metrics, stratified by WHO region. Our results show a profound geographic imbalance: 56.7 % of trials occurred in the Western Pacific and 27.7 % in the Americas, while regions like Africa, the Eastern Mediterranean, and South-East Asia hosted almost none. Academic institutions were the primary sponsors (69.2 %). Correlational analysis revealed no statistically significant link between trial frequency and childhood cancer mortality rates. The only significant correlation found was between the number of trials and alcohol-related deaths in children aged 5–14 (r² = 0.67; p = 0.04). These findings indicate a stark misalignment between scientific research and the regions with the greatest pediatric oncology burden, highlighting significant scientific inequity. We conclude that structural barriers and misaligned funding prevent vulnerable populations from accessing these transformative therapies, necessitating a strategic shift in global policy to ensure equitable research distribution.
本研究旨在评估嵌合抗原受体(CAR) t细胞治疗儿童癌症临床试验的地理分布,并评估其与全球健康需求的一致性。采用定量方法,我们分析了来自世卫组织全球卫生研究与发展观察站(2007-2022年)的317项临床试验数据,以及按世卫组织区域分层的全球卫生指标。我们的研究结果显示了严重的地域不平衡:56.7%的试验发生在西太平洋,27.7%发生在美洲,而非洲、东地中海和东南亚等地区几乎没有试验。学术机构是主要发起者(69.2%)。相关分析显示,试验频率与儿童癌症死亡率之间没有统计学上显著的联系。唯一发现的显著相关性是试验数量与5-14岁儿童酒精相关死亡之间的相关性(r²= 0.67;p = 0.04)。这些发现表明,科学研究与儿童肿瘤负担最重的地区之间存在明显的不一致,突出了重大的科学不平等。我们得出的结论是,结构性障碍和不一致的资助阻碍了弱势群体获得这些变革性疗法,因此有必要在全球政策上进行战略性转变,以确保公平的研究分配。
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引用次数: 0
Nurse-enabled survivorship in early-stage breast cancer (1970–2024): A critical bibliometric review of models, outcomes, and PRO-driven workflows 早期乳腺癌中护士支持的生存率(1970-2024):对模型、结果和pro驱动工作流程的关键文献计量学回顾
IF 2 Q3 HEALTH POLICY & SERVICES Pub Date : 2025-11-14 DOI: 10.1016/j.jcpo.2025.100664
Alex S. Borromeo , Russell John Catalig , Abigail Ramos , Catherine Atud , Josefina Reyes , Walton Wider

Background

Survivorship has become a central component of early-stage breast cancer care, yet implementation of evidence-based models remains inconsistent across settings. Nurses now serve as the backbone of follow-up, psychosocial support, and patient-reported outcome (PRO) monitoring, linking hospital and community-based care.

Objectives

To map nursing’s scholarly contributions to survivorship, identify dominant research clusters and intellectual anchors, and explain why proven nurse-enabled and PRO-driven models remain underutilized in clinical practice.

Interventions/Methods

A critical bibliometric review was conducted using the Web of Science Core Collection (1970–2024). Descriptive metrics and VOSviewer co-citation and co-word analyses were used to examine publication trends, thematic clusters, and intellectual linkages.

Results

A total of 196 peer-reviewed articles (5,361 citations; H-index = 39) were identified. Four key clusters emerged: (1) risk-stratified nurse-led follow-up, (2) psychosocial well-being and rehabilitation, (3) shared decision-making and communication, and (4) PRO and quality-of-life infrastructure. Evidence supports streamlined, nurse-enabled care as safe and effective, with PRO-integrated triage reducing emergency visits and improving outcomes. Persistent gaps relate to limited reimbursement, workforce constraints, and PRO collection without actionable triage protocols.

Conclusions

Nursing constitutes the operational core of survivorship. Embedding PROs as clinical triggers, integrating psychosocial and rehabilitation services, and aligning funding with nurse-led, equity-focused pathways can transform survivorship delivery.

Implications for Oncology Nursing Practice

Oncology nurses should lead risk-stratified follow-up, normalize distress and exercise screening, and operationalize PRO triage with defined response times. Institutions should reimburse nurse-led encounters, report survivorship quality indicators, and scale culturally responsive models to achieve equitable survivorship care.
背景:生存已经成为早期乳腺癌护理的核心组成部分,然而基于证据的模型的实施在不同的环境中仍然不一致。护士现在是随访、社会心理支持和患者报告结果监测的骨干,将医院和社区护理联系起来。目的:描绘护理对幸存者的学术贡献,确定主要的研究集群和智力锚点,并解释为什么经过验证的护士支持和pro驱动模型在临床实践中仍未得到充分利用。干预措施/方法:使用Web of Science核心馆藏(1970-2024)进行了重要的文献计量学综述。使用描述性指标和VOSviewer共引和共词分析来检查出版趋势,专题集群和智力联系。结果:共收录同行评议论文196篇(引用5361次,H-index = 39)。出现了四个关键集群:(1)风险分层护士主导的随访;(2)社会心理健康和康复;(3)共同决策和沟通;(4)PRO和生活质量基础设施。证据支持简化的、由护士支持的护理是安全有效的,采用pro集成的分诊减少了急诊次数并改善了结果。持续的差距与有限的报销、劳动力限制和没有可操作的分类协议的PRO收集有关。结论:护理是生存的操作核心。将专业支持作为临床触发因素,整合社会心理和康复服务,并将资金与护士主导的、以公平为重点的途径相结合,可以改变幸存者救助的方式。对肿瘤护理实践的启示:肿瘤护士应领导风险分层随访,使痛苦和运动筛查正常化,并在明确的响应时间内实施PRO分诊。机构应该报销护士领导的接触,报告幸存者质量指标,并扩大文化响应模式,以实现公平的幸存者护理。
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引用次数: 0
US pharmaceutical tariffs and European oncology: Policy risks, openings, and clinical implications 美国药品关税和欧洲肿瘤学:政策风险、开放和临床影响。
IF 2 Q3 HEALTH POLICY & SERVICES Pub Date : 2025-11-10 DOI: 10.1016/j.jcpo.2025.100665
Javier-David Benitez-Fuentes
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引用次数: 0
Overall survival as a safety guardrail in cancer drug trials 癌症药物试验中的总生存期作为安全保障。
IF 2 Q3 HEALTH POLICY & SERVICES Pub Date : 2025-11-09 DOI: 10.1016/j.jcpo.2025.100666
Rashidul Alam Mahumud
Surrogate endpoints have accelerated access to oncology drugs but often leave uncertainty about net patient benefit. We propose a pragmatic framework that recentres overall survival (OS) as both the definitive patient-centred efficacy endpoint and a safety guardrail capable of detecting net harm that intermediate measures may miss. The framework comprises four pillars. First, designing for harm exclusion: protocols should prespecify a clinically meaningful OS harm margin, power event-driven follow-up to exclude or detect that margin with precision, and mandate independent data monitoring committee oversight. Analyses should match explicit estimands and pair hazard ratios with restricted mean survival time to accommodate non-proportional hazards. Second, handling crossover and post-progression therapy: when crossover is ethical or unavoidable, trials should adopt treatment-policy estimands for the primary question and prespecified causal sensitivity analyses. Protocols must map access to guideline-concordant post-progression care, record uptake and timing, and distinguish biological dilution from health-system scarcity. Third, using surrogates with discipline: when OS cannot feasibly be primary, sponsors should submit a disease-specific surrogate dossier summarising trial- and patient-level validation and quantifying expected translation to OS, while continuing to collect OS and assess it against the prespecified harm boundary. Fourth, preventing missingness-driven bias: continue outcome collection after treatment discontinuation, set triggers for asymmetric loss to follow-up, and perform structured tipping-point analyses. We recommend a regulatory traffic-light aligned to OS maturity, green (traditional approval), amber (time-limited with confirmatory obligations), red (standards unmet), and conditioning economic conclusions (QALYs, net monetary benefit) on OS harm exclusion. Operationalising OS as a safety guardrail protects patients and strengthens the credibility and value of cancer trials.
替代终点加速了肿瘤药物的可及性,但往往留下患者净获益的不确定性。我们提出了一个实用的框架,该框架将总生存期(OS)作为最终的以患者为中心的疗效终点和能够检测中间措施可能遗漏的净危害的安全护栏。首先,危害排除设计:协议应该预先指定临床意义上的操作系统危害范围,支持事件驱动的随访,以精确排除或检测该范围,并授权独立的数据监测委员会进行监督。分析应匹配明确的估计,并将风险比与有限的平均生存时间配对,以适应非比例风险。第二,处理交叉和进展后治疗:当交叉符合伦理或不可避免时,试验应采用针对主要问题的治疗政策估计和预先指定的因果敏感性分析。方案必须标明与指南一致的进展后护理的可及性,记录的吸收和时间安排,并将生物稀释与卫生系统稀缺性区分开来。第三,有纪律地使用替代药物:当OS不可能是主要的时,申办者应该提交一份特定疾病的替代药物档案,总结试验和患者水平的验证,量化预期的OS转化,同时继续收集OS并根据预先规定的危害边界对其进行评估。第四,预防缺失驱动的偏倚:在停止治疗后继续收集结果,设置不对称随访损失的触发因素,并进行结构化的临界点分析。我们推荐一个与操作系统成熟度相一致的监管红绿灯,绿色(传统的批准),琥珀色(有时间限制的确认义务),红色(未达到标准),以及对操作系统危害排除的调节经济结论(qaly,净货币效益)。操作系统作为安全护栏保护患者,并加强癌症试验的可信度和价值。
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引用次数: 0
Letter to the Editor – Commentary on “Continued tobacco use beyond cancer diagnosis in India – A systematic review and meta-analysis” 致编辑的信-对“印度癌症诊断之外的持续烟草使用-系统回顾和荟萃分析”的评论。
IF 2 Q3 HEALTH POLICY & SERVICES Pub Date : 2025-11-09 DOI: 10.1016/j.jcpo.2025.100661
Ruihang Luo , Maosen Liu , Wei Zhong, Hongyi Lai, Kun Ai, Mingshan Liu
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引用次数: 0
Geographic variation in experiences of cancer care in Scotland: Insights and policy implications from the Scottish Cancer Patient Experience Survey 苏格兰癌症护理经验的地理差异:来自苏格兰癌症患者经验调查的见解和政策含义。
IF 2 Q3 HEALTH POLICY & SERVICES Pub Date : 2025-11-09 DOI: 10.1016/j.jcpo.2025.100663
Peter Murchie , David McLernon , Alexander Murchie , David Nelson , Natalia Calanzani

Background

Rural residence is associated with reduced cancer survival but research linking geography to patient experience is limited. Evidence from Scotland suggests rural patients experience cancer care differently. The Scottish Cancer Patient Experience Survey (SCPES) provides nationally representative, patient-reported datasets capturing experiences across the cancer care pathway, offering a unique opportunity to examine geographic variation in care.

Methods

SCPES 2024 responses from 4540 adults were analysed. Data were weighted to account for non-response bias and structured for analysis by Scottish Government six-fold Urban-Rural classification. From 102 SCPES items, 32 were selected by two researchers independently (percentage agreement and Cohen’s kappa were calculated) based on relevance to cancer pathway stages, travel burden or rural-urban disparities. Analyses were conducted in three blocks: (1) pathway-relevant questions (n = 15), (2) distance to care components (n = 7), and (3) specific travel difficulties (n = 10). Cross-tabulations employed weighted counts, with χ² tests and linear-by-linear trend analyses for ordinal responses. Bonferroni correction was applied within each block.

Results

Rural-dwelling respondents reported significantly longer journeys to access aspects of their cancer care and were more likely to report specific travel difficulties. Rural-dwellers were significantly less-likely to be given the chance to participate in research. Despite this, rural-dwelling cancer patients were as likely as urban-dwellers to report that their cancer experience was positive overall.

Conclusion

Satisfaction with cancer care in Scotland is positive irrespective of geography. Further research should focus on sustainably reducing travel-burden for rural-dwelling cancer patients and ensuring equal opportunities for them to participate in qualitative and quantitative research.

Policy summary

Efficient and meaningful analysis of publicly available cancer data should be encouraged. Future UK policy should support sustainable access to care for rural patients. Equal opportunities for research participation among rural patients should also be promoted. The SCPES should continue, and an additional question on overall support would be a useful addition.
背景:农村居住与癌症存活率降低有关,但将地理位置与患者经历联系起来的研究有限。来自苏格兰的证据表明,农村病人的癌症治疗经历不同。苏格兰癌症患者体验调查(SCPES)提供了具有全国代表性的、患者报告的数据集,这些数据集捕获了整个癌症治疗途径的经验,为检查治疗的地理差异提供了独特的机会。方法:对4540名成人的SCPES 2024问卷进行分析。数据被加权以解释无反应偏差,并被苏格兰政府进行六倍城乡分类分析。从102个SCPES项目中,有32个是由两位研究人员根据与癌症途径阶段、旅行负担或城乡差异的相关性独立选择的(百分比一致性和科恩kappa计算)。分析分为三个部分:(1)与路径相关的问题(n=15),(2)到护理中心的距离成分(n=7),(3)特定的旅行困难(n=10)。交叉表采用加权计数、χ 2检验和线性逐线性趋势分析对有序响应。在每个区块内应用Bonferroni校正。结果:居住在农村的受访者表示,为了获得癌症治疗,他们的行程要长得多,而且更有可能报告具体的旅行困难。农村居民获得参与研究机会的可能性要小得多。尽管如此,居住在农村的癌症患者和城市居民一样,报告他们的癌症经历总体上是积极的。结论:无论地理位置如何,苏格兰人对癌症治疗的满意度都是积极的。进一步的研究应侧重于可持续地减少居住在农村的癌症患者的旅行负担,并确保他们有平等的机会参与定性和定量研究。政策摘要:应鼓励对公开的癌症数据进行有效和有意义的分析。英国未来的政策应该支持农村病人获得可持续的医疗服务。还应促进农村患者参与研究的平等机会。SCPES应继续进行,关于总体支持的额外问题将是一个有用的补充。
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引用次数: 0
Inequalities in the utilisation of curative-intent treatments for early-stage non-small cell lung cancer across urban and rural areas: A population-based study in England 在城市和农村地区,早期非小细胞肺癌的治疗意图治疗使用的不平等:英国一项基于人群的研究。
IF 2 Q3 HEALTH POLICY & SERVICES Pub Date : 2025-11-08 DOI: 10.1016/j.jcpo.2025.100662
Eva Kagenaar , David G. Lugo-Palacios , Ajay Aggarwal , Andrew Hutchings , Lu Han , Stephen O’Neill , Bernard Rachet , John Edwards , Corinne Faivre-Finn , Richard Grieve

Background

This study aims to assess sociodemographic inequalities in anticancer treatments including curative-intent surgery and curative-intent radiotherapy for people with early-stage non-small cell lung cancer (NSCLC), across urban and rural areas.

Methods

A total of 38,229 eligible patients with early-stage NSCLC were identified from the English cancer registry and information on anti-cancer treatment (curative-intent surgery, curative-intent radiotherapy, palliative treatment, no anticancer treatment) was extracted from linked data. Multinomial logistic regression models estimated the association of sociodemographic measures with receipt of anticancer treatments, adjusting for case-mix and travel time.

Results

Those living in more deprived areas were less likely to receive curative-intent surgery with a mean change in the estimated probability of −11.1 %age points (95 % CI −12.5;-9.6), but more likely to receive curative radiotherapy with a mean change of + 4.3 %age points (95 % CI 3.0;5.6), than those living in the least deprived areas. Compared to those living in the five largest cities, the estimated probability of receiving curative-intent surgery was lower for those living in other urban areas with a mean change of −2.7 %age points (95 % CI −3.7;-0.2), and those living in rural areas, with a mean change of −2.2 %age points (95 % CI −3.7;-0.6). The probability of receiving curative-intent radiotherapy was lower by on average −2.3 %age points (95 % CI −3.2;-1.3) for those living in other urban areas versus the largest cities, but the corresponding reduction for those living in rural areas was small (-0.5 %age points, 95 % CI −1.9;0.1).

Conclusion

There are major inequalities in receipt of curative-intent surgery for early-stage NSCLC according to deprivation, and urban versus rural residence with smaller inequalities for receipt of curative-intent radiotherapy.

Policy Implications

The further expansion of radiotherapy services could reduce inequalities in uptake of curative-intent treatment for NSCLC, but the impact on patient outcomes must be assessed.
背景:本研究旨在评估城市和农村地区早期非小细胞肺癌(NSCLC)患者在抗癌治疗方面的社会人口不平等,包括治愈性手术和治愈性放疗。方法:从英国癌症登记处共确定38229例符合条件的早期NSCLC患者,并从相关数据中提取抗癌治疗信息(治愈意图手术,治愈意图放疗,姑息治疗,无抗癌治疗)。多项逻辑回归模型估计了社会人口统计指标与接受抗癌治疗的关系,调整了病例组合和旅行时间。结果:与生活在最贫困地区的患者相比,生活在更贫困地区的患者接受治愈性手术的可能性更小,估计概率平均变化为-11.1个百分点(95% CI -12.5;-9.6),但接受治愈性放疗的可能性更大,平均变化为+4.3个百分点(95% CI 3.0;5.6)。与生活在五个最大城市的患者相比,生活在其他城市地区的患者接受治疗目的手术的估计概率较低,平均变化为-2.7个百分点(95% CI -3.7;-0.2),生活在农村地区的患者平均变化为-2.2个百分点(95% CI -3.7;-0.6)。与大城市相比,生活在其他城市地区的患者接受治疗意图放疗的概率平均降低了-2.3个百分点(95% CI -3.2;-1.3),但生活在农村地区的患者的相应降低幅度很小(-0.5个百分点,95% CI -1.9;0.1)。结论:根据剥夺程度,早期NSCLC在接受治愈性手术方面存在较大的不平等,城市居民与农村居民在接受治愈性放疗方面存在较小的不平等。政策意义:放疗服务的进一步扩大可以减少非小细胞肺癌治疗的不平等,但对患者预后的影响必须进行评估。
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引用次数: 0
National cancer plans and primary care a systematic analysis comparing Latin American and non-Latin American countries 国家癌症计划和初级保健拉丁美洲和非拉丁美洲国家比较的系统分析。
IF 2 Q3 HEALTH POLICY & SERVICES Pub Date : 2025-11-08 DOI: 10.1016/j.jcpo.2025.100659
Andrea Rioseco , Klaus Puschel , Gabriela Soto , Zdenka Vescovi , Isabella Fuentes , Felipe Dibiase , Gonzalo Ulloa , Carolina Goic , Jon Emery , Beti Thompson , Javiera Martinez-Gutierrez

Background

Cancer is a growing global health issue, particularly in middle- and high-income countries. National Cancer Control Plans (NCCPs) have emerged as a strategic response to reduce this burden. Primary care plays a crucial role across the cancer care continuum, yet its systematic inclusion in NCCPs remains unclear—especially in countries facing significant epidemiological challenges.

Methods

This study employed a systematic qualitative design based on document analysis. Using the READ (Ready material, Extract data, Analyze, Distil) model, we examined the integration of primary care policies and practices in eight NCCPs: four from non-Latin American high-income countries (NLAHIc—Australia, Canada, the United States, and the United Kingdom) and four from Latin American middle-income countries (LATAMc—Argentina, Colombia, Chile, and Mexico). Covidence software facilitated the systematic text review, and a set of evidence-based key performance indicators (KPIs) was developed to guide the analysis.

Results

Primary care integration varied across countries. LATAMc NCCPs showed greater inclusion of primary care than NLAHIc. Health promotion strategies were more consistently present in NLAHIc, while LATAMc better integrated primary prevention into primary care. However, only 50 % of KPIs for secondary prevention and 15 % for survivorship care were included in LATAMc. Palliative care was more consistently integrated in LATAMc (75 %) than in NLAHIc (33 %).
Policy Summary
This is the first study to benchmark NCCPs from Latin American and high-income countries using evidence-based KPIs to assess primary care involvement in cancer control. Findings highlight an urgent need to strengthen primary care integration. LATAMc should improve secondary prevention and survivorship care, while NLAHIc need to better incorporate primary prevention and palliative care into their NCCPs.
背景:癌症是一个日益严重的全球健康问题,特别是在中等收入和高收入国家。国家癌症控制计划(NCCPs)已成为减轻这一负担的战略对策。初级保健在整个癌症护理连续体中发挥着至关重要的作用,但其在国家重点控制方案中的系统纳入情况尚不清楚,特别是在面临重大流行病学挑战的国家。方法:本研究采用文献分析为基础的系统定性设计。使用READ (Ready material, Extract data, Analyze,蒸馏)模型,我们检查了8个国家的初级保健政策和实践的整合:4个来自非拉丁美洲高收入国家(nlaic -澳大利亚、加拿大、美国和英国),4个来自拉丁美洲中等收入国家(latam -阿根廷、哥伦比亚、智利和墨西哥)。covid - 19软件为系统的文本审查提供了便利,并制定了一套基于证据的关键绩效指标(kpi)来指导分析。结果:初级保健整合在不同国家有所不同。与NLAHIc相比,LATAMc NCCPs显示出更多的初级保健内容。健康促进战略在nahic更一致地存在,而LATAMc更好地将初级预防纳入初级保健。然而,只有50%的二级预防kpi和15%的生存护理kpi被纳入LATAMc。姑息治疗在LATAMc(75%)比NLAHIc(33%)更一致地整合。这是第一个对拉丁美洲和高收入国家的国家预防和控制方案进行基准研究,使用基于证据的kpi来评估初级保健参与癌症控制的情况。调查结果强调了加强初级保健一体化的迫切需要。LATAMc应该改善二级预防和生存护理,而NLAHIc需要更好地将一级预防和姑息治疗纳入其NCCPs。
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引用次数: 0
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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Journal of Cancer Policy
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