Journal of Cancer Policy最新文献

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Geographic disparities in access to oncologists and association with cancer outcomes in the United States 在美国,获得肿瘤学家的地理差异及其与癌症预后的关系。
IF 2
Journal of Cancer Policy Pub Date : 2026-03-01 Epub Date: 2026-01-05 DOI: 10.1016/j.jcpo.2026.100704
Ryan J. Crowley , Jag S. Lally , David M. Kline , Amanda M. Bunting
{"title":"Geographic disparities in access to oncologists and association with cancer outcomes in the United States","authors":"Ryan J. Crowley ,&nbsp;Jag S. Lally ,&nbsp;David M. Kline ,&nbsp;Amanda M. Bunting","doi":"10.1016/j.jcpo.2026.100704","DOIUrl":"10.1016/j.jcpo.2026.100704","url":null,"abstract":"<div><h3>Background</h3><div>Access to oncologists is crucial to quality cancer care. We aimed to assess the geospatial distribution of oncologists in the United States and its association with cancer mortality.</div></div><div><h3>Methods</h3><div>We used county-level oncologist data from the 2025 Doctors and Clinicians national downloadable file and county-level cancer outcome data from the 2018–2022 State Cancer Profiles. We assessed urban-rural differences in the distribution of oncologists in the United States and used Local Moran’s I to identify clusters of high and low oncologist density and cancer mortality rates. We classified counties using the 2023 Rural-Urban Continuum Codes (RUCC) with RUCC 1–3 as urban and RUCC 4–9 as rural.</div></div><div><h3>Results</h3><div>13,332 oncologists were identified nationwide. The median oncologist density per 100,000 population was 6.0 in urban counties and 0.0 in rural counties (p-value &lt;0.001). The median age-adjusted cancer mortality rate per 100,000 population was 156.1 in urban counties and 166.8 in rural counties (p-value &lt;0.001). Clusters of low oncologist density were observed in the South.</div></div><div><h3>Conclusion</h3><div>There are significant geospatial differences in oncologist accessibility and cancer outcomes. Targeted interventions are necessary to ensure that rural areas maintain access to oncology care.</div></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"47 ","pages":"Article 100704"},"PeriodicalIF":2.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145917518","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
Premature discontinuation of clinical trials in biliary tract cancers: Predictors and implications 胆道肿瘤临床试验过早终止:预测因素和影响
IF 2
Journal of Cancer Policy Pub Date : 2026-03-01 Epub Date: 2026-01-29 DOI: 10.1016/j.jcpo.2026.100709
Matthew T. Gao, Rishi R. Patel, Suriya Baskar, Deepak Vadehra, Nicholas Hornstein, Timothy J. Brown, Udhayvir S. Grewal
{"title":"Premature discontinuation of clinical trials in biliary tract cancers: Predictors and implications","authors":"Matthew T. Gao,&nbsp;Rishi R. Patel,&nbsp;Suriya Baskar,&nbsp;Deepak Vadehra,&nbsp;Nicholas Hornstein,&nbsp;Timothy J. Brown,&nbsp;Udhayvir S. Grewal","doi":"10.1016/j.jcpo.2026.100709","DOIUrl":"10.1016/j.jcpo.2026.100709","url":null,"abstract":"","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"47 ","pages":"Article 100709"},"PeriodicalIF":2.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146078051","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
Towards feasible and effective prostate cancer screening: initial insights from the PRAISE-U project 迈向可行和有效的前列腺癌筛查:PRAISE-U项目的初步见解
IF 2
Journal of Cancer Policy Pub Date : 2026-03-01 Epub Date: 2025-12-17 DOI: 10.1016/j.jcpo.2025.100689
M.J. van Harten , R.C.N. van den Bergh , S. Collen , A. Chandran , H. van Poppel , M.J. Roobol , the PRAISE-U consortium
{"title":"Towards feasible and effective prostate cancer screening: initial insights from the PRAISE-U project","authors":"M.J. van Harten ,&nbsp;R.C.N. van den Bergh ,&nbsp;S. Collen ,&nbsp;A. Chandran ,&nbsp;H. van Poppel ,&nbsp;M.J. Roobol ,&nbsp;the PRAISE-U consortium","doi":"10.1016/j.jcpo.2025.100689","DOIUrl":"10.1016/j.jcpo.2025.100689","url":null,"abstract":"","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"47 ","pages":"Article 100689"},"PeriodicalIF":2.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147394098","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
Incorporation of HPV-DNA molecular test into the Brazilian healthcare system 将HPV-DNA分子检测纳入巴西医疗保健系统。
IF 2
Journal of Cancer Policy Pub Date : 2026-03-01 Epub Date: 2026-02-14 DOI: 10.1016/j.jcpo.2026.100713
Dilceu Silveira Tolentino Júnior
{"title":"Incorporation of HPV-DNA molecular test into the Brazilian healthcare system","authors":"Dilceu Silveira Tolentino Júnior","doi":"10.1016/j.jcpo.2026.100713","DOIUrl":"10.1016/j.jcpo.2026.100713","url":null,"abstract":"<div><div>Cervical cancer is a major public health problem and is among the leading causes of female mortality in Brazil, especially in regions with less access to health services. In this context, in 2025 the country began the gradual implementation of the HPV-DNA molecular test in the Unified Health System, considered by the World Health Organization to be a more sensitive and effective primary screening method than conventional cytopathological examination. The objective of this study was to analyze the main political, logistical, and structural challenges involved in the national adoption of this technology, considering aspects of laboratory infrastructure, logistics, financing, professional training, and equity of access. The methodology adopted was based on the documentary analysis of ministerial decrees, technical guides, and official reports. The implementation of this technological innovation began in 15 municipalities in 12 Brazilian states, potentially benefiting approximately seven million women between 25 and 64 years of age annually. The interval between tests, when negative, increases from three to five years, optimizing resources and expanding coverage. However, challenges remain related to expanding laboratory capacity, transporting samples, maintaining diagnostic quality, and women's adherence to the new protocol. In conclusion, the incorporation of the HPV-DNA oncogenic molecular test represents a milestone for cervical cancer screening in Brazil, with the potential to reduce female mortality, provided it is accompanied by sustainable investments in infrastructure, health education, and territorial equity strategies.</div></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"47 ","pages":"Article 100713"},"PeriodicalIF":2.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146208046","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
Hospital mortality and associated factors in the oncology unit of Treichville University Hospital (Côte d’Ivoire): A cross-sectional study Treichville大学医院肿瘤科的医院死亡率和相关因素(Côte科特迪瓦):一项横断面研究。
IF 2
Journal of Cancer Policy Pub Date : 2026-03-01 Epub Date: 2026-02-19 DOI: 10.1016/j.jcpo.2026.100714
Kouamé Konan Yvon Kouassi , Bitti Addé Odo , Yenahaban Lazare Touré , Pétiori Gningayou Laurence Touré , N'guessan Malan Prosper Mébiala , Audrey Fleur Sessegnon , Akissi Marie Barbara Yvonne Nogbou , Mohamed Kassir Agnidé Madiou , Ibrahima Kalil Condé , Joel Betsaleel. Grahouri , Moctar Touré , Innocent Adoubi
{"title":"Hospital mortality and associated factors in the oncology unit of Treichville University Hospital (Côte d’Ivoire): A cross-sectional study","authors":"Kouamé Konan Yvon Kouassi ,&nbsp;Bitti Addé Odo ,&nbsp;Yenahaban Lazare Touré ,&nbsp;Pétiori Gningayou Laurence Touré ,&nbsp;N'guessan Malan Prosper Mébiala ,&nbsp;Audrey Fleur Sessegnon ,&nbsp;Akissi Marie Barbara Yvonne Nogbou ,&nbsp;Mohamed Kassir Agnidé Madiou ,&nbsp;Ibrahima Kalil Condé ,&nbsp;Joel Betsaleel. Grahouri ,&nbsp;Moctar Touré ,&nbsp;Innocent Adoubi","doi":"10.1016/j.jcpo.2026.100714","DOIUrl":"10.1016/j.jcpo.2026.100714","url":null,"abstract":"<div><h3>Background</h3><div>Cancer represents a major public health challenge in sub-Saharan Africa. In Côte d’Ivoire, more than 70 % of cancers are diagnosed at an advanced stage, often requiring hospitalization, especially for palliative care. However, data on hospital mortality and its determinants in oncology services remain scarce.</div></div><div><h3>Objective</h3><div>To identify factors associated with in-hospital mortality among cancer patients admitted to the long-term hospitalization unit (HLD) of the oncology department at Treichville University Hospital.</div></div><div><h3>Methods</h3><div>We conducted a cross-sectional analytical study over 12 months (November 2022 to October 2023), including all patients aged ≥ 16 years, with a confirmed cancer diagnosis, admitted to the HLD unit. Data were collected from medical records and analyzed using STATA. Logistic regression was used to identify factors independently associated with hospital mortality.</div></div><div><h3>Results</h3><div>A total of 318 hospitalizations were recorded for 239 patients. The mean age was 53.0 ± 14.3 years, with a female predominance (58 %). The most frequent comorbidities were hypertension (20.4 %) and diabetes (9.7 %). Advanced-stage cancers were observed in over 90 % of cases. The most common tumor sites were colorectal (26.7 %), breast (17.3 %), and liver (7.3 %). In-hospital mortality was 30.5 %. Multivariate analysis identified the following factors as significantly associated with mortality: prostate cancer (p &lt; 0.05), emergency admission (p &lt; 0.01), poor performance status (WHO score ≥3) (p &lt; 0.01), in-hospital fever (p &lt; 0.05), delayed transfusion (p &lt; 0.05), and occurrence of complications during hospitalization (p &lt; 0.01).</div></div><div><h3>Conclusion</h3><div>Hospital mortality among cancer patients in Côte d’Ivoire remains high and is not always directly attributable to cancer progression. Early identification and management of modifiable factors such as emergency admissions, transfusion delays, and hospital-acquired complications could improve patient outcomes. Prospective multicenter studies are needed to support evidence-based oncology care in sub-Saharan Africa.</div></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"47 ","pages":"Article 100714"},"PeriodicalIF":2.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146776826","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
Economic evaluation of the one-dose HPV vaccination program in Nigeria 尼日利亚单剂HPV疫苗接种计划的经济评价。
IF 2
Journal of Cancer Policy Pub Date : 2026-03-01 Epub Date: 2025-12-06 DOI: 10.1016/j.jcpo.2025.100675
Tianjiao Gao , Marwa Farag , Sohail Agha , Linda Mobula , Xiaohui Hou , Guohong Li , Wu Zeng
{"title":"Economic evaluation of the one-dose HPV vaccination program in Nigeria","authors":"Tianjiao Gao ,&nbsp;Marwa Farag ,&nbsp;Sohail Agha ,&nbsp;Linda Mobula ,&nbsp;Xiaohui Hou ,&nbsp;Guohong Li ,&nbsp;Wu Zeng","doi":"10.1016/j.jcpo.2025.100675","DOIUrl":"10.1016/j.jcpo.2025.100675","url":null,"abstract":"<div><h3>Background</h3><div>This study retrospectively examines the cost-effectiveness of the national HPV vaccination program using the program cost and coverage data in Nigeria.</div></div><div><h3>Methods</h3><div>We conducted a cost-effectiveness analysis of the HPV vaccination program compared with no vaccination in Nigeria, adopting both health system and societal perspectives. A static Markov model simulating HPV infection and cervical cancer outcomes was developed for a cohort of girls aged 9–14 years, followed until age 100. The model comprised primarily the following health states: susceptible, cervical cancer, and death. It further incorporated three additional pathways for patients with cervical cancer, including those with successful treatment, with treatment failure, and with no treatment.</div></div><div><h3>Results</h3><div>The incremental cost-effectiveness ratio (ICER) was estimated at $268.67 per quality-adjusted life year (QALY) gained from the health system perspective and $217.85 per QALY gained from the societal perspective. Both ICERs were well below the cost-effectiveness threshold of one-time GDP per capita in Nigeria ($806.95). Key drivers of cost-effectiveness included vaccine cost, treatment success rate, cervical cancer treatment coverage, and cervical cancer utility values.</div></div><div><h3>Discussion</h3><div>The single-dose HPV vaccination program is highly cost-effective in Nigeria, compared to the status quo of no vaccination. To ensure long-term sustainability, the Nigerian government should strengthen financing mechanisms and the healthcare system to support the program.</div></div><div><h3>Policy Summary</h3><div>Single dose HPV vaccination is cost-effective in Nigeria. It is crucial to obtain sustainable vaccine financing and improve treatment to maintain the program impact.</div></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"47 ","pages":"Article 100675"},"PeriodicalIF":2.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145709939","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
Interventions to improve cancer screening adherence in migrants and ethnic minorities in the European Region: A systematic review. 改善欧洲地区移民和少数民族癌症筛查依从性的干预措施:一项系统综述。
IF 2
Journal of Cancer Policy Pub Date : 2026-03-01 Epub Date: 2025-12-11 DOI: 10.1016/j.jcpo.2025.100677
Chiara De Marchi , Federica Di Lullo , Caterina Ferrari , Valentina Pettinicchio , Alessandra Sinopoli , Paolo lombardo , Maria Elena Tosti , Silvia Declich , Scilla Pizzarelli , Franca D’Angelo , Maria Teresa Riccardi , Fabiana Arrivi , Francesca Maria Forestiero , Virginia Rosca , Alessandra Romano , Daniela Marotta
{"title":"Interventions to improve cancer screening adherence in migrants and ethnic minorities in the European Region: A systematic review.","authors":"Chiara De Marchi ,&nbsp;Federica Di Lullo ,&nbsp;Caterina Ferrari ,&nbsp;Valentina Pettinicchio ,&nbsp;Alessandra Sinopoli ,&nbsp;Paolo lombardo ,&nbsp;Maria Elena Tosti ,&nbsp;Silvia Declich ,&nbsp;Scilla Pizzarelli ,&nbsp;Franca D’Angelo ,&nbsp;Maria Teresa Riccardi ,&nbsp;Fabiana Arrivi ,&nbsp;Francesca Maria Forestiero ,&nbsp;Virginia Rosca ,&nbsp;Alessandra Romano ,&nbsp;Daniela Marotta","doi":"10.1016/j.jcpo.2025.100677","DOIUrl":"10.1016/j.jcpo.2025.100677","url":null,"abstract":"<div><h3>Introduction</h3><div>Adherence to cancer screening programs is crucial for reducing cancer-related mortality, yet migrant and ethnic minorities (MEMs) often show lower participation rates compared to the general population. This systematic review aims to identify effective strategies to improve cancer screening adherence among MEMs in the WHO European Region.</div></div><div><h3>Methods</h3><div>A systematic review was conducted following PRISMA guidelines, searching Medline, Embase, Scisearch, and Biosis for studies published up to October 13th, 2025. Eligible studies included quantitative and quali-quantitative studies focused on interventions aimed to increase adherence to cancer screening among MEMs. Study quality was assessed using the Joanna Briggs Institute Critical Appraisal Tools.</div></div><div><h3>Results</h3><div>We included 12 studies, conducted in the United Kingdom, Norway, Israel, and Turkey. All of the interventions focused on breast and cervical cancer screening, with no studies addressing colorectal cancer screening. Effective interventions incorporated culturally and linguistically tailored strategies, such as community-based education, use of cultural mediators, multilingual reminds and information, free transport service and language support. Community-based and informal health education approaches significantly increased screening uptake, particularly among South Asian and ultraOrthodox Jewish women. However, interventions targeting men or colorectal cancer screening were lacking, indicating a significant research gap.</div></div><div><h3>Policy Summary</h3><div>This review highlights the need for gender-inclusive, culturally sensitive policies to improve screening adherence among MEMs. Policymakers should develop integrated screening campaigns that address multiple cancer types, particularly colorectal cancer, and ensure the inclusion of male populations. Enhancing community involvement is essential to achieve equitable screening coverage in line with EU health targets.</div></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"47 ","pages":"Article 100677"},"PeriodicalIF":2.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145752305","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
Speed and nature of national comprehensive cancer network updates following food and drug administration approvals & withdrawals 食品和药物管理局批准和撤销后国家综合癌症网络更新的速度和性质。
IF 2
Journal of Cancer Policy Pub Date : 2026-03-01 Epub Date: 2026-02-16 DOI: 10.1016/j.jcpo.2026.100717
Christopher L. Rios , Alyson Haslam , Vinay Prasad
{"title":"Speed and nature of national comprehensive cancer network updates following food and drug administration approvals & withdrawals","authors":"Christopher L. Rios ,&nbsp;Alyson Haslam ,&nbsp;Vinay Prasad","doi":"10.1016/j.jcpo.2026.100717","DOIUrl":"10.1016/j.jcpo.2026.100717","url":null,"abstract":"<div><h3>Objective</h3><div>To characterize the speed and nature of National Comprehensive Cancer Network (NCCN) guideline updates following Food and Drug Administration (FDA) approvals and withdrawals.</div></div><div><h3>Methods</h3><div>We conducted a retrospective observational study to measure and compare the speed of updates to the NCCN guidelines following FDA cancer approvals and withdrawals between October 2022 and July 2024. We also descriptively analyzed the frequency of specific modifications and levels of recommendations made by the NCCN.</div></div><div><h3>Results</h3><div>Of 91 drug indications analyzed, 83 were newly approved, and eight were withdrawn indications. The NCCN incorporated new indications with similar speed regardless of approval pathway (median of 16 days after accelerated approvals vs 20 days after regular approvals; p = 0.59). Notably, the NCCN added or modified 19 approved indications (22.3 %) before FDA approval. Additionally, the NCCN was faster to incorporate approvals than to remove or modify withdrawn indications from its guidelines (19 days vs. 57 days, p = 0.014). Following the official FDA withdrawal of the eight indications in our data set, the NCCN removed only three (37.5 %) from its guidelines and continued to recommend five (62.5 %). Of these five withdrawn indications, the NCCN downgraded three (37.5 %) in recommendation level and left two (25 %) unmodified, endorsing them with a Category 2 A recommendation.</div></div><div><h3>Conclusions &amp; Policy Summary</h3><div>We found that the NCCN rapidly incorporated new FDA-approved indications but, delayed updating FDA-withdrawn indications, removing them from guidelines in only a minority of cases. This work highlights a systemic pattern that may drive financial toxicity and suboptimal patient care, underscoring the need for two bodies for the optimal practice of oncologic medicine: one that guides clinicians on all potential treatment options without informing reimbursement coverage, and one that works to usher in cost-effective, evidence-based care to the US market.</div></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"47 ","pages":"Article 100717"},"PeriodicalIF":2.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146221331","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
Explaining rare cancer survival gaps: A comparative policy review of six European countries 解释罕见癌症生存差距:六个欧洲国家的比较政策回顾
IF 2
Journal of Cancer Policy Pub Date : 2026-03-01 Epub Date: 2025-12-17 DOI: 10.1016/j.jcpo.2025.100685
Hüseyin Örün , Hilal Polat
{"title":"Explaining rare cancer survival gaps: A comparative policy review of six European countries","authors":"Hüseyin Örün ,&nbsp;Hilal Polat","doi":"10.1016/j.jcpo.2025.100685","DOIUrl":"10.1016/j.jcpo.2025.100685","url":null,"abstract":"","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"47 ","pages":"Article 100685"},"PeriodicalIF":2.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147394745","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
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
Journal of Cancer Policy Pub Date : 2026-03-01 Epub 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
{"title":"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","authors":"Allan Cramer ,&nbsp;Freja Karuna Hemmingsen Sørup ,&nbsp;Hanne Rolighed Christensen ,&nbsp;Kristian Karstoft ,&nbsp;Tonny Studsgaard Petersen","doi":"10.1016/j.jcpo.2025.100660","DOIUrl":"10.1016/j.jcpo.2025.100660","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div></div><div><h3>Policy summary</h3><div>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.</div></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"47 ","pages":"Article 100660"},"PeriodicalIF":2.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145472435","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
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