Journal of Cancer Policy最新文献

{"title":"Defining the role and competencies of the medical oncologist in diagnostic and therapeutic care pathways: Consensus recommendations from the Italian association of medical oncology (AIOM)","authors":"Rossana Berardi ,&nbsp;Francesca Rossi ,&nbsp;Valentina Tarantino ,&nbsp;Michele De Tursi ,&nbsp;Angelo Dinota ,&nbsp;Giancarlo Di Pinto ,&nbsp;Roberto Bianco ,&nbsp;Francesco Leonardi ,&nbsp;Alessandra Bearz ,&nbsp;Alessandra Fabi ,&nbsp;Alessandro Pastorino ,&nbsp;Franco Nolè ,&nbsp;Paolo Alessandroni ,&nbsp;Francesco Carrozza ,&nbsp;Lucio Buffoni ,&nbsp;Tiziana Latiano ,&nbsp;Daniele Farci ,&nbsp;Massimiliano Spada ,&nbsp;Carmelo Bengala ,&nbsp;Stefania Kinspergher ,&nbsp;Roberto Papa","doi":"10.1016/j.jcpo.2026.100701","DOIUrl":"10.1016/j.jcpo.2026.100701","url":null,"abstract":"<div><h3>Background</h3><div>Diagnostic and Therapeutic Care Pathways (DTCPs) are clinical governance tools aimed at managing the care of specific patient populations through the coordinated application of standardized, evidence-based interventions by multidisciplinary teams. Their primary goal is to ensure equitable, timely, and cost-effective access to high-quality care.</div></div><div><h3>Materials and method</h3><div>A panel of recognized opinion leaders, endorsed by the Italian Association of Medical Oncology (AIOM), was convened to develop a consensus document defining the role of the medical oncologist within Multidisciplinary Oncology Groups (MOGs) and DTCPs. Employing the RAND/UCLA Appropriateness Method in its “consensus conference” format, the panel evaluated a series of statements derived from a review of the scientific literature and expert-generated Good Practice Points (GPPs). These statements addressed five key areas.<ul><li><span>1.</span><span><div>Skills of the Oncologist in the diagnostic phase</div></span></li></ul></div><div><ul><li><span>2.</span><span><div>Follow up</div></span></li></ul><ul><li><span>3.</span><span><div>Palliative care</div></span></li></ul></div><div><ul><li><span>4.</span><span><div>Management of the diagnostic and therapeutic care pathway of the oncological patient</div></span></li></ul><ul><li><span>5.</span><span><div>Medical therapy.</div></span></li></ul></div><div>To further support each topic, illustrative case studies were presented.</div></div><div><h3>Results</h3><div>A total of 21 articles met the inclusion criteria, yielding 88 evidence-based recommendations. Additionally, panel members contributed 9 further GPPs based on clinical expertise. Of the 97 total recommendations, 95 received a relevance score above 7, while 2 scored between 4 and 6.9; none scored below 4.</div></div><div><h3>Conclusions</h3><div>This consensus effort and the resulting document represent a comprehensive evaluation of the available evidence regarding the role of medical oncologists within MOGs and DTCPs. The objective is to propose standardized criteria for the optimal management of cancer patients (pts) across all phases of care from initial diagnosis and staging to treatment, follow-up, and end-of-life support.</div></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"47 ","pages":"Article 100701"},"PeriodicalIF":2.0,"publicationDate":"2026-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145977401","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}

{"title":"The out-of-pocket cost of colorectal cancer care in Nigeria: A prospective analysis","authors":"Funmilola Olanike Wuraola ,&nbsp;Ryan Fodero ,&nbsp;Olalekan Olasehinde ,&nbsp;Adewale A. Aderounmu ,&nbsp;Adeoluwa O. Adeleye ,&nbsp;Oluwatosin Z. Omoyiola ,&nbsp;Adewale O. Adisa ,&nbsp;Juliet Lumati ,&nbsp;Israel A. Owoade ,&nbsp;T. Peter Kingham ,&nbsp;Olusegun I. Alatise ,&nbsp;Gregory Knapp","doi":"10.1016/j.jcpo.2026.100705","DOIUrl":"10.1016/j.jcpo.2026.100705","url":null,"abstract":"<div><h3>Background</h3><div>In Nigeria, cancer patients often pay for care out-of-pocket, leading to catastrophic health expenditure (CHE). However, data on the true costs and economic burden of cancer care are limited. This study prospectively analyzes direct and indirect out-of-pocket costs for colorectal cancer (CRC) care at a tertiary hospital in Southwest Nigeria.</div></div><div><h3>Methods</h3><div>Patients newly diagnosed with CRC between August 2019 and April 2024 were enrolled. Trained research assistants administered a context-specific questionnaire at admission and six months later. Patients reported household income and all cancer-related expenditures. CHE was defined using three standard thresholds: healthcare costs exceeding 40 % of capacity-to-pay or 10 % and 25 % of annual income.</div></div><div><h3>Results</h3><div>Data were collected from 50 patients with a mean age of 57.9 years (SD 14.3). Twelve percent of patients (6/50) presented with stage I disease. Forty-two percent (21/50) had stage II disease, while 46 % (23/50) had stage III or IV disease at presentation. 24 % (12/50) of patients had right-sided disease, while 38 % (19/50) had rectal cancer, 4 (21 %) of whom received neoadjuvant radiotherapy. Ninety percent (45/50) of patients received systemic chemotherapy. The mean annual capacity-to-pay for the cohort was $3930.71(SD $5108.10), while the mean cost of care was $5286.16(SD $2919.77). Indirect costs, including travel, lodging, and lost income, accounted for $2144.04(SD $2478.68) of the total cost of care. Between 95.2 % and 100 % of our cohort experienced a CHE. Only 20 % (10/50) of our cohort had health insurance.</div></div><div><h3>Conclusions</h3><div>More than 95 % of patients seeking care for CRC at a tertiary care facility in Southwest Nigeria experience a CHE because of out-of-pocket costs associated with accessing care. There is the need for more studies on interventions to reduce these cost barriers for patients.</div></div><div><h3>Policy Summary</h3><div>A more effective and accessible health insurance scheme is urgently needed in Nigeria to protect CRC patients from CHE.</div></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"47 ","pages":"Article 100705"},"PeriodicalIF":2.0,"publicationDate":"2026-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145925546","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}

{"title":"The benefits and harms of cancer screening programmes for adults with intellectual disabilities: A systematic review","authors":"Martin McMahon ,&nbsp;Samantha Flynn ,&nbsp;Samantha A. Johnson ,&nbsp;Chris Stinton","doi":"10.1016/j.jcpo.2026.100706","DOIUrl":"10.1016/j.jcpo.2026.100706","url":null,"abstract":"<div><h3>Background</h3><div>Cancer screening programmes are an important public health initiative aimed at reducing morbidity and mortality through early cancer detection. The available evidence suggests lower screening uptake among people with intellectual disabilities, but the balance of benefits and harms of screening is unknown. The aim of this systematic review is to examine the health outcomes (mortality, morbidity) and harms of cancer screening programmes for adults with intellectual disabilities.</div></div><div><h3>Methods</h3><div>The review is registered on the Open Science Framework Registries: <span><span>https://osf.io/8vmkb</span><svg><path></path></svg></span>. A systematic search of published peer-reviewed and grey literature was conducted from inception up to 28th February 2025 using MEDLINE, EMBASE, Web of Science, PsycINFO, and relevant organisational websites. Experts were also consulted about evidence on the benefits and harms of cancer screening programmes for adults with intellectual disabilities. Two reviewers independently screened titles and abstracts and assessed full texts against the eligibility criteria.</div></div><div><h3>Results</h3><div>3104 records were identified, and 232 full-text articles were assessed for eligibility. No study met the inclusion criteria.</div></div><div><h3>Policy summary</h3><div>There is a lack of evidence on the benefits and harms of cancer screening programmes for people with intellectual disabilities. There are numerous studies relating to coverage, uptake, and factors influencing participation in cancer screening programmes. Participation should not be assumed to equate to better outcomes, and there is a risk of ‘equity-washing’ if this is used as a basis for practice. There is an urgent need to evaluate the entire screening pathway for people with intellectual disabilities, for the associated outcomes, benefits, and harms.</div></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"47 ","pages":"Article 100706"},"PeriodicalIF":2.0,"publicationDate":"2026-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145953130","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}

{"title":"Accelerating cancer treatment optimisation: A multistakeholder roadmap from the Cancer Medicines Forum","authors":"Denis Lacombe ,&nbsp;Fábio Cardoso Borges ,&nbsp;Ana E. Amariutei ,&nbsp;Christopher M. Booth ,&nbsp;Guy Brusselle ,&nbsp;Raffaella Casolino ,&nbsp;Pierre Demolis ,&nbsp;Rosa Giuliani ,&nbsp;Daniel A. Goldstein ,&nbsp;Gwenaelle Gravis ,&nbsp;Martin Kaiser ,&nbsp;Iphigenie Korakis ,&nbsp;Momir Radulovic ,&nbsp;Richard Sullivan ,&nbsp;Bertrand Tombal ,&nbsp;Beate Wieseler ,&nbsp;Michael Zaiac ,&nbsp;Caroline Voltz-Girolt ,&nbsp;Francesco Pignatti","doi":"10.1016/j.jcpo.2025.100700","DOIUrl":"10.1016/j.jcpo.2025.100700","url":null,"abstract":"<div><div>Medicines are often tested in highly controlled environments during clinical trials aimed at rapid development and thorough assessment of their benefits and risks, with key efficacy and safety aspects evaluated for regulatory approval. However, important questions regarding the optimisation of medicines’ use in clinical practice may remain unanswered at the time of marketing authorisation, notably those related to the optimal dose, duration, schedule, sequence, and combination of treatments. This knowledge gap is particularly critical in oncology, where patient quality of life must be prioritised, and there is the pressing need to understand the most efficient use of costly innovative therapies in the context of rising cancer incidence and prevalence. Addressing these challenges requires multi-stakeholder collaboration.</div><div>Organisations within the Cancer Medicines Forum (CMF), co-chaired by the European Organisation for Research and Treatment of Cancer and the European Medicines Agency, have advocated for policy actions promoting treatment optimisation research within the European Union. To advance this objective, the CMF convened a multidisciplinary stakeholder workshop, offering a platform for collaborative dialogue by bringing together experts from governmental bodies, regulatory agencies, health technology assessment bodies, patient organisations, academia, learned societies, industry, public health organisations, clinicians, and investigators. This workshop aimed to examine existing barriers and explore strategies to integrate treatment optimisation into the current cancer clinical research framework, ultimately providing key recommendations, summarised in this review, to systematically embed treatment optimisation in oncology research.</div></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"47 ","pages":"Article 100700"},"PeriodicalIF":2.0,"publicationDate":"2026-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145925520","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}

{"title":"Population-Based Cancer Screening analysis in Northern Portugal Using Process Mining","authors":"Hugo Monteiro ,&nbsp;Mariana Oliveira ,&nbsp;Ricardo Martinho ,&nbsp;João Reis ,&nbsp;Fernando Tavares ,&nbsp;Óscar Felgueiras ,&nbsp;Carlos Martins","doi":"10.1016/j.jcpo.2026.100702","DOIUrl":"10.1016/j.jcpo.2026.100702","url":null,"abstract":"<div><h3>Background</h3><div>This study focuses on the Colorectal Cancer Screening Program in Northern Portugal, aiming to evaluate the disruption effects on its performance and efficiency.</div></div><div><h3>Methods</h3><div>We conducted an observational analyses of 271 637 administrative records from 2020 to 2022. Administrative timestamps were converted into a step-by-step dataset of screening activities (an “event log”) and analysed using process mining and comparative performance analysis across time periods and ACeS (primary care administrative clusters).</div></div><div><h3>Results</h3><div>Consultation‑to‑colonoscopy time lengthened by 53 %, rising from a median 58 days (IQR 29–92) in early 2020 to 89 days (IQR 53–127) in 2021, before improving to 73 days in 2022. Conversely, referral‑to‑consultation time fell from 110 days to 26 days (−76 %), reflecting targeted backlog clearance. Screening volumes declined in 2020 but recovered above baseline levels by 2022. Performance differences across primary care administrative clusters were significant (p &lt; 0.001), with some units outperforming regional median transition times. Early adoption of automated electronic referrals and flexible consultation scheduling may have contributed to improved programme performance during the recovery period following pandemic-related disruptions. Substantial heterogeneity across units was observed for key transitions, indicating uneven disruption and recovery patterns across administrative units.</div></div><div><h3>Conclusion</h3><div>Process Mining techniques revealed critical vulnerabilities in the screening program during the initial stages of the period in analysis (matching the pandemic). These findings support targeted monitoring and prioritisation of operational improvements to reduce avoidable delays and strengthen continuity of population-based screening.</div></div><div><h3>Policy summary</h3><div>Policies aimed at strengthening healthcare service continuity and operational capacity benefit from analytical methods like process mining. Key recommendations include standardizing workflows, enhancing coordination between primary care and hospital services, and investing in digital monitoring systems to mitigate disruptions and ensure continuity in cancer screening programs during periods of system stress.</div></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"47 ","pages":"Article 100702"},"PeriodicalIF":2.0,"publicationDate":"2026-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145918884","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}

{"title":"Current opinions on lung cancer screening in the Nordic countries: A survey-based study","authors":"Morten Borg ,&nbsp;Kirill Neumann ,&nbsp;Jannie Christina Frølund ,&nbsp;Ghida Khalife ,&nbsp;Zaigham Saghir ,&nbsp;Aija Knuuttila ,&nbsp;Haseem Ashraf ,&nbsp;Johan Isaksson ,&nbsp;Torben Riis Rasmussen","doi":"10.1016/j.jcpo.2026.100703","DOIUrl":"10.1016/j.jcpo.2026.100703","url":null,"abstract":"<div><h3>Introduction</h3><div>Lung cancer is the leading cause of cancer-related death worldwide, with early detection critical for curative treatment. Low-dose computed tomography (LDCT) can detect lung cancer at earlier stages, but its implementation in the Nordic countries remains limited. This study surveys invasive respiratory physicians in Sweden, Finland, Norway, and Denmark to explore their views on LDCT screening.</div></div><div><h3>Methods</h3><div>A web-based survey was conducted among invasive respiratory physicians in Denmark, Norway, Sweden, and Finland to assess opinions on lung cancer screening. Responses were analysed using descriptive statistics and the Kruskal-Wallis test.</div></div><div><h3>Results</h3><div>A total of 125 respondents from 54 Nordic hospitals completed the survey. The majority reported no prior experience with LDCT screening. Most physicians were familiar with LDCT and recognized its potential to improve early detection, though opinions on national implementation were mixed. Key barriers identified included financial constraints, lack of trained personnel, and limited access to CT scanners. Significant differences were observed by country, hospital type, and years of clinical experience (p &lt; 0.05).</div></div><div><h3>Conclusion</h3><div>Nordic respiratory physicians acknowledge the benefits of LDCT screening for early lung cancer detection but highlight substantial implementation challenges, particularly related to resources and personnel. Addressing these barriers, standardizing protocols, and exploring supportive measures such as risk-scores and AI-assisted imaging will be essential for successful adoption of national screening programs across the Nordic region.</div></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"47 ","pages":"Article 100703"},"PeriodicalIF":2.0,"publicationDate":"2026-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145918859","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}

{"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":"2026-01-05","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}

{"title":"Social framework to judge the importance of breast cancer","authors":"Zsuzsa Réka Pozsár ,&nbsp;Krisztina Tóth ,&nbsp;Marianna Moizs ,&nbsp;János Révész ,&nbsp;Klára Tatár-Kiss ,&nbsp;Judit Tittmann ,&nbsp;Aliz Nikolényi ,&nbsp;Ágnes Anna Kovács ,&nbsp;Tamás Mátrai ,&nbsp;Borbála Judit Szabó ,&nbsp;Erzsébet Hajduné Kovács ,&nbsp;Csilla Czene ,&nbsp;Dalma Hosszú ,&nbsp;Anna Bögös ,&nbsp;Tu Thanh Nguyen ,&nbsp;Júlia Zemplényiné Bartha ,&nbsp;Tamás Ágh ,&nbsp;Zoltán Kaló ,&nbsp;Magdolna Dank","doi":"10.1016/j.jcpo.2025.100679","DOIUrl":"10.1016/j.jcpo.2025.100679","url":null,"abstract":"<div><h3>Background</h3><div>Breast cancer (BC) has profound effects on patients, households, and society, necessitating a multidimensional approach to understand its implications fully. This study aimed to develop a conceptual model for a social framework (SF) that assists in identifying group common values and needs for BC interventions in Hungary. The SF reflects diverse perspectives, including healthcare professionals, patients, caregivers, policymakers of health and social care, health technology developers, and corporate and philanthropic supporters of BC initiatives.</div></div><div><h3>Methods</h3><div>A narrative literature review was conducted to identify value elements (VEs) of BC. VEs were categorized into groups and further clustered into sub-groups within each main category. This literature-based conceptual model was contextualized and adapted to the Hungarian setting through individual and group interviews with various societal group representatives. A closing validation meeting fostered stakeholders’ reflection on the draft model.</div></div><div><h3>Results</h3><div>The final conceptual model incorporates five traditional (e.g., clinical outcomes, adverse events, survival, and direct medical costs), nine patient-centric (e.g., personal milestones, patient experience, and financial burden), and seven societal (e.g., disease severity, the presence of the disease around us, and indirect costs) VEs.</div></div><div><h3>Conclusion</h3><div>Our study is the first to present a comprehensive SF that provides insights into key disease challenges and why different BC interventions are important to various stakeholder groups via capturing traditional, patient-centric, and societal VEs. It informs decision-making within and beyond the healthcare domain by supporting the evaluation of policies, health technologies, public and civil society initiatives in Hungary.</div></div><div><h3>Policy Summary</h3><div>While BC is a priority disease area for all stakeholder groups, their views on what contributes to the success of policy decisions are different. If policymakers intend to represent the interests of the whole society, they should aim to express the value of policy interventions in a comprehensive SF.</div></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"47 ","pages":"Article 100679"},"PeriodicalIF":2.0,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145828480","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}

{"title":"Progression-free survival is strongly associated with overall survival in relapsed/refractory diffuse large B-cell lymphoma in the CAR T-cell era","authors":"Alexander M. Gorzewski ,&nbsp;Rebecca Z. Steuer ,&nbsp;Charmi Trivedi ,&nbsp;Kaavya Mandi ,&nbsp;Christina A. Raker ,&nbsp;Charles J. Milrod ,&nbsp;Ari R. Pelcovits","doi":"10.1016/j.jcpo.2025.100699","DOIUrl":"10.1016/j.jcpo.2025.100699","url":null,"abstract":"<div><h3>Introduction</h3><div>In clinical trials for diffuse large B-cell lymphoma (DLBCL), progression-free survival (PFS) has been used as a validated surrogate endpoint to help expedite drug development and regulatory approval. The advent of chimeric antigen receptor (CAR) T-cell therapies has radically changed the treatment landscape, potentially prolonging post-progression survival and weakening the correlation between PFS and overall survival (OS). This study evaluates the utility of PFS as a surrogate endpoint for OS in relapsed/refractory (R/R) DLBCL in the CAR T-cell era.</div></div><div><h3>Materials and methods</h3><div>A systematic review of Phase 3 randomized clinical trials for R/R DLBCL initiated after 2015 was conducted. A weighted linear regression analysis was performed to assess the correlation between PFS and OS.</div></div><div><h3>Results</h3><div>Six trials, comprising 1577 patients, met the inclusion criteria. Weighted linear regression demonstrated a coefficient of determination (R²) of 0.88 (p = 0.0054), indicating a strong association between PFS and OS in R/R DLBCL trials conducted since the introduction of CAR T-cell therapy.</div></div><div><h3>Discussion</h3><div>These findings provide evidence that PFS remains a valid and strong surrogate endpoint for OS in the contemporary R/R DLBCL treatment landscape. This supports the continued use of PFS as a primary endpoint in regulatory studies for new therapies for R/R DLBCL and provides important information for health policy discussions on drug approval, insurance coverage, and reimbursement decisions for aggressive lymphomas.</div></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"47 ","pages":"Article 100699"},"PeriodicalIF":2.0,"publicationDate":"2025-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145811053","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}

{"title":"INNOVATIVE ONCOLOGY TRIAL DESIGNS: TIME TO ACT A review with recommendations of the Cancer Drug Development Forum.","authors":"Rosa Giuliani, Nafsika Kronidou-Horst, Christina Yap, Aáron Sosa Mejia, Lada Leyens, Theodor Framke, Fergus Sweeney, Laurence Collette, Rachel Giles, Jan Bogaerts, Peter van de Ven, Stefan N Symeonides","doi":"10.1016/j.jcpo.2025.100696","DOIUrl":"https://doi.org/10.1016/j.jcpo.2025.100696","url":null,"abstract":"<p><p>(250 of max. 250 words) INTRODUCTION: Clinical oncology trial design constantly adapts and evolves to meet the needs of all stakeholders, from patients to regulators. This evolution has however also led to an increase in the complexity of clinical development, and investigators are expected to invest more time and money in planning and running their studies and overall clinical and regulatory pathway.</p><p><strong>Methods: </strong>Here we review recent innovations in trial designs, study endpoints, and relevant regulatory guidelines, before making recommendations to enhance the clinical trial ecosystem in the EU.</p><p><strong>Results: </strong>Innovative clinical study designs that go beyond traditional randomised, double-blinded, placebo-controlled trials often promise greater flexibility and efficiency in the conduct of oncology studies, but adoption has been slow. Furthermore, the increased complexity associated with innovative trials means that coordination between all relevant stakeholders is essential to every phase of clinical development. Despite recent advances, there is a risk that Europe is becoming seen as a less attractive location for clinical trials, perhaps in part due to regulatory challenges and operational complexity. More needs to be done to improve patient access to medicines and processes across Europe.</p><p><strong>Policy summary: </strong>Innovative trial designs promise more efficient, flexible, and inclusive clinical trials, but more needs to be done to encourage their adoption if the advantages outweigh the limitations. Partnership and coordination between all stakeholders, from patients to regulators, and at all phases, is more important than ever. Finally, effective action is urgently needed if expertise and investment in clinical trial research in Europe is not to fall behind the rest of the world.</p>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":" ","pages":"100696"},"PeriodicalIF":2.0,"publicationDate":"2025-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145805869","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}