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Real-World Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application Approvals from 2015–2020

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Organized structure of real-world evidence best practices: moving from fragmented recommendations to comprehensive guidance

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Evaluation of reporting quality of cohort studies using real-world data based on RECORD: systematic review

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A guide to artificial intelligence for cancer researchers

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The ESMO Tumour-Agnostic Classifier and Screener (ETAC-S): a tool for assessing tumour-agnostic potential of molecularly guided therapies and for steering drug development

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Progress and challenges of artificial intelligence in lung cancer clinical translation

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Real-world effectiveness comparison of first-line palbociclib, ribociclib or abemaciclib plus endocrine therapy in advanced HR-positive/HER2-negative BC patients: results from the multicenter PALMARES-2 study

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Generating and using real-world data: A worthwhile uphill battle

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Real-World Clinical Outcomes With Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer

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Determinants of 5-year survival in patients with advanced NSCLC with PD-L1≥50% treated with first-line pembrolizumab outside of clinical trials: results from the Pembro-real 5Y global registry

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From Text to Tables: A Local Privacy Preserving Large Language Model for Structured Information Retrieval from Medical DocumentsPreprint

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Predicting resistance to chemotherapy using chromosomal instability signatures

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Resistance to immunotherapy in non-small cell lung cancer: Unraveling causes, developing effective strategies, and exploring potential breakthroughs

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Causal Inference in Oncology: Why, What, How and When

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Differences in immune-related toxicity between PD-1 and PD-L1 inhibitors: a retrospective cohort study in patients with advanced cancer

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Comprehensive genome profiling for treatment decisions in patients with metastatic tumors: real-world evidence meta-analysis and registry data implementation

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Efficacy, safety and differential outcomes of immune‐chemotherapy with gemcitabine, cisplatin and durvalumab in patients with biliary tract cancers: A multicenter real world cohort

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Use and outcomes of trastuzumab deruxtecan in HER2-positive and HER2-low metastatic breast cancer in a real-world setting: a nationwide cohort study

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Real-World outcomes with sacituzumab govitecan among breast cancer patients with central nervous system metastases

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Real-world effectiveness of CDK4/6i in first-line treatment of HR+/HER2− advanced/metastatic breast cancer: updated systematic review

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Machine learning approaches for EGFR mutation status prediction in NSCLC: an updated systematic review

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A population-based study on trajectories of HER2 status during neoadjuvant chemotherapy for early breast cancer and metastatic progression

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Artificial intelligence in myeloid malignancies: Clinical applications of machine learning in myelodysplastic syndromes and acute myeloid Leukemia

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Overall survival after CDK4/6 inhibitor dose reduction in women with metastatic breast cancer

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A Review and Comparative Case Study Analysis of Real-World Evidence in European Regulatory and Health Technology Assessment Decision Making for Oncology Medicines

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Exosomal biomarkers in leukemia: translational potential and regulatory challenges for precision medicine applications

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Real life outcome analysis of breast cancer brain metastases treated with Trastuzumab Deruxtecan

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Clinical decision impact of HER2DX, an algorithm-powered genomic diagnostic in early-stage HER2-positive breast cancer: results from a prospective real-world study

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Real-world outcomes of treatment strategy between first-line osimertinib, first/second-generation EGFR-TKIs followed by osimertinib and without osimertinib in advanced EGFR-mutant NSCLC

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Prognostic significance of tumour Ki-67 dynamics during neoadjuvant treatment in patients with breast cancer: a population-based cohort study

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Adaptive validation strategies for real-world clinical artificial intelligence

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Olaparib as maintenance therapy in non resectable pancreatic adenocarcinoma associated with homologous recombination deficiency profile: A French retrospective multicentric AGEO real-world study

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Risk of colorectal cancer by family history of both colorectal carcinomas and colorectal polyps: a nationwide cohort study

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Real-world evidence reported for clinical efficacy evaluation in European Public Assessment Reports of authorised targeted therapies for solid malignancies: a comprehensive review (2018-2022)

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Oncology education in the age of artificial intelligence

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First-Line Chemo-Immunotherapy in SCLC: Outcomes of a Binational Real-World Study

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Characteristics of non-randomised studies of drug treatments: cross sectional study

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Therapeutic Sequences of Systemic Therapy After Atezolizumab Plus Bevacizumab for Hepatocellular Carcinoma: Real‐World Analysis of the IMMUreal Cohort

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Real-world evidence of the efficacy of neoadjuvant pembrolizumab in triple-negative breast cancer: A surgeon's point of view

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Real-world patterns of treatment and response in metastatic renal cell carcinoma: a multicentre UK-wide review with UK Renal Oncology Collaborative (UK ROC)

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Immune-related adverse events in patients treated with immunotherapy for locally advanced or metastatic NSCLC in real-world settings: a systematic review and meta-analysis

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The impact of inter-cycle treatment delays on 5-year all-cause mortality in early-stage breast cancer: A retrospective cohort study

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Real-world safety and effectiveness data of trastuzumab deruxtecan and sacituzumab govitecan in breast cancer: a Hellenic Cooperative Oncology Group study

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Real-world outcomes of PARP inhibitor maintenance in advanced ovarian cancer: a focus on disease patterns and treatment modalities at recurrence

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Axillary surgery in early breast cancer: real-world analysis of the INSEMA-trial at three certified university breast cancer centers in Germany regarding the omission of sentinel lymph node biopsy

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PROMENADE: pembrolizumab for early ER-low/HER2-negative breast cancer, real-world French cohort

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Patients with Advanced or Metastasised Non-Small-Cell Lung Cancer with Viscum album L. Therapy in Addition to PD-1/PD-L1 Blockade: A Real-World Data Study

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Overall Survival and Economic Impact of Triple-Negative Breast Cancer in Brazilian Public Health Care: A Real-World Study

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Stakeholders’ Perspectives Toward the Use of Patient Registry Data for Decision-Making on Medicines: A Cross-Sectional Survey

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Prognosis After Pathologic Complete Response to Neoadjuvant Therapy in Early-Stage Breast Cancer: A Population-Based Study

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Lenvatinib for patients with previously treated advanced thymic carcinoma in real-world settings

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Impact of neoadjuvant compared to adjuvant chemotherapy on prognosis in patients with hormone-receptor positive / HER2-negative breast cancer: A propensity score matching population-based study

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Harnessing the Potential of Real-World Evidence in the Treatment of Colorectal Cancer: Where Do We Stand?

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Endometriosis and endometrial cancer: A propensity score-adjusted real-world data study

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Squamous cell carcinoma arising in chronically damaged skin (Marjolin’s Ulcer): still an unmet need in the era of immunotherapy

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Effectiveness of post-trastuzumab deruxtecan treatments and incidence of interstitial lung disease in HER2-positive metastatic breast cancer: a real-world, observational cohort study

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Real-world effectiveness of PARP inhibitors after CDK4/6 inhibitor therapy in BRCA-mutated HR-positive/HER2-negative advanced breast cancer

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Time trends in real-world treatment patterns and survival in patients diagnosed with de novo HER2+ metastatic breast cancer: an analysis of the SONABRE registry

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Cardiovascular toxicities in cancer patients treated with immune checkpoint inhibitors: multicenter study using natural language processing on Belgian hospital data

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Occurrence of dMMR/MSI-H tumor during follow-up in Lynch syndrome patients treated with immune checkpoint inhibitors for metastatic digestive cancer between 2015 and 2024: a retrospective analysis of a monocentric prospective cohort study

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Multimodal analysis of whole slide images in colorectal cancer

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R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 15

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Palbociclib: Randomized Studies and Real-world Evidence as the Basis for Therapeutic Planning in Metastatic Breast Cancer

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Exploring machine learning tools in a retrospective case-study of patients with metastatic non-small cell lung cancer treated with first-line immunotherapy: A feasibility single-centre experience

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Real-world effectiveness and safety of second- or third-line pegylated liposomal irinotecan plus 5-fluorouracil and folinic acid in pancreatic ductal adenocarcinoma in Spain

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Incidence and outcome of brain and/or leptomeningeal metastases in HER2-low metastatic breast cancer in the French ESME cohort

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Integrating Aggressive-Variant Prostate Cancer-Associated Tumor Suppressor Gene Status with Clinical Variables to Refine Prognosis and Predict Androgen Receptor Pathway Inhibitor Response in Metastatic Hormone-Sensitive Setting

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Real-time data in cancer registries: Validation of an automated data extraction system

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Strategies for premedication and G-CSF application in sacituzumab govitecan treatment of patients with triple-negative breast cancer: multicenter insights

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Treatment gaps and survival outcomes of hepatocellular carcinoma: insights from a nationwide, claims-based study

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Benefit of immune checkpoint inhibitors as adjuvant treatment for acral melanomas

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Combination of Radiotherapy and Immunotherapy in Advanced Non–Small Cell Lung Cancer

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Safety and efficacy of encorafenib–cetuximab combination in BRAF-mutated metastatic colorectal cancer: real-world evidence from the CONFIDENCE Spanish multicenter study

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Outcome and safety of lurbinectedin as compassionate use in extensive stage small cell lung cancer: A multicentric international cohort

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Precision Oncology Guided by Genomic Profiling in Breast Cancer: Real-World Data from a Molecular Tumor Board

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Impact of consolidation immunotherapy after definitive chemoradiotherapy in locally advanced esophageal squamous cell carcinoma: a real-world multicenter study

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Prevalence, clinicopathologic features and long-term overall survival of early breast cancer patients eligible for adjuvant abemaciclib and/or ribociclib

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Real-World Evaluation of Immune-Related Endocrinopathies in Metastatic NSCLC Patients Treated with ICIs in Romania

Coniac, S., Costache-Outas, M. C., Antone-Iordache, I.-L., Barbu, A.-M., Bardan, V. T., Zamfir, A., Ionescu, A.-I., & Badiu, C. (2025) · Cancers · doi:10.3390/cancers17071198 · Cited by 4 · see citing works

Agnostic drug development revisited

Hernando‐Calvo, A., Rossi, A., Vieito, M., Voest, E. E., & Garralda, E. (2024) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2024.102747 · Cited by 4 · see citing works

Beyond Clinical Trials: Understanding Neurotrophic Tropomyosin Receptor Kinase Inhibitor Challenges and Efficacy in Real-World Pediatric Oncology

Vince, C. S. C., Brassesco, M. S., Mançano, B. M., Gregianin, L. J., Carbone, E. K., Castro, A. D. A. E., Yamachira, V. S., da Silva, R. Z. M., Mariano, C. S., da Mata, J. F., et al. (2024) · JCO Precision Oncology · doi:10.1200/po.23.00713 · Cited by 4 · see citing works

Real-world prevalence, treatment and survival of “high risk” early breast cancer, with mandatory testing of gBRCA1/2 mutation according to the OlympiA trial inclusion criteria: Data from a population-based registry

Ladoire, S., Kamga, A. M., Galland, L., Desmoulins, I., Mayeur, D., Kaderbhaï, C., Ilie, S. M., Hennequin, A., Jankowski, C., Albuisson, J., et al. (2024) · The Breast · doi:10.1016/j.breast.2024.103789 · Cited by 4 · see citing works

Real-world evidence on efficacy and toxicity of targeted therapy in older melanoma patients treated in a tertiary-hospital setting

Stoff, R., Markovic, S. N., McWilliams, R., Kottschade, L., Montane, H. N., Dimou, A., Dudek, A., Tan, W., Dronca, R., Seetharam, M., et al. (2024) · Melanoma research · doi:10.1097/cmr.0000000000000997 · Cited by 4 · see citing works

Prognostic impact of depth of response and early tumour shrinkage in patients with BRAF V600E -mutated metastatic colorectal cancer treated with targeted therapy

Vetere, G., Germani, M. M., Antoniotti, C., Salvatore, L., Pietrantonio, F., Lonardi, S., Bensi, M., Ghelardi, F., Calegari, M. A., Intini, R., et al. (2025) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359241299975 · Cited by 4 · see citing works

Thyroid disorders as predictors of cemiplimab efficacy in recurrent/metastatic cervical cancer: real-world evidence from Poland

Pacholczak‐Madej, R., Lisik-Habib, M., Mądry, R., Szarszewska, M., Borysiewicz, Z., Gabalewicz, K., Iwańska, E., Szatkowski, W., Püsküllüoğlu, M., Jakubowicz, J., et al. (2025) · Frontiers in Immunology · doi:10.3389/fimmu.2025.1604826 · Cited by 4 · see citing works

Utilization and safety of trastuzumab emtansine (T-DM1): a nationwide population-based study using the French National Health Data System

Jourdain, H., Mansouri, I., Meglio, A. D., Zureik, M., & Haddy, N. (2024) · ESMO Real World Data and Digital Oncology · doi:10.1016/j.esmorw.2024.100045 · Cited by 4 · see citing works

How AI will transform cancer care

Kather, J. N., & Abernethy, A. P. (2024) · Annals of Oncology · doi:10.1016/j.annonc.2024.08.2335 · Cited by 4 · see citing works

Real-World Evidence Acceptability and Use in Breast Cancer Treatment Decision-Making in the United States: Call-to-Action from a Multidisciplinary Think Tank

Khozin, S., Dreyer, N. A., Galante, D., Liu, R., Neumann, P., Nussbaum, N. C., O’Shaughnessy, J., Patt, D. A., Rimawi, M. F., Rugo, H. S., et al. (2025) · Advances in Therapy · doi:10.1007/s12325-025-03201-y · Cited by 3 · see citing works

Complete responders in patients with HER2-positive metastatic breast cancer: a real-world SONABRE study

Ding, N., Visserman, R., Geurts, S. M. E., Tol, J., Vriens, B. E. P. J., Aaldering, K. N. A., Boon, E., Dercksen, M. W., van den Berkmortel, F. W. P. J., Pepels, M. J. A. E., et al. (2025) · The Breast · doi:10.1016/j.breast.2025.104583 · Cited by 3 · see citing works

Real-world survival outcomes of neoadjuvant versus adjuvant chemotherapy in operable triple-negative breast cancer: a propensity score matched registry-based study

El‐Naggar, A. I., Karakatsanis, A., & Valachis, A. (2025) · Acta Oncologica · doi:10.2340/1651-226x.2025.43990 · Cited by 3 · see citing works

Epidemiology and clinical characteristics of mesothelioma in the Chinese population: a multicenter study

Yang, S., Hao, Y., Wang, K., Xu, H., Huang, L., Xu, L., Meng, R., Li, B., Huang, J., Zhu, Y., et al. (2025) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359251378879 · Cited by 3 · see citing works

Sacituzumab Govitecan initial dose reduction in polish patients with metastatic triple-negative breast cancer: impact on efficacy and safety

Pieniążek, M., Kubeczko, M., Las‐Jankowska, M., Polakiewicz-Gilowska, A., Łacko, A., Jarząb, M., Bielčiková, Z., Pacholczak‐Madej, R., & Püsküllüoğlu, M. (2025) · Cancer Chemotherapy and Pharmacology · doi:10.1007/s00280-025-04823-3 · Cited by 3 · see citing works

Time to Treatment Failure as an End Point in Pragmatic Oncology Trials: Association With Progression-Free Survival Across Randomized Studies

Dalrymple, J., Symons, R., Sjoquist, K. M., Lord, S., Woodford, R. G., Friedlander, M. L., Simes, R. J., & Lee, C. K. (2026) · JCO Precision Oncology · doi:10.1200/po-26-00011 · Cited by 3 · see citing works

Improving olaparib exposure to optimize adverse effects management

Sterlé, M., Puszkiel, A., Burlot, C., Pereira, E., Bellesœur, A., Percin, S. D., Beinse, G., Fumet, J.-D., Favier, L., Niogret, J., et al. (2024) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359241248328 · Cited by 3 · see citing works

Effectiveness and safety of first-line pembrolizumab plus chemotherapy in patients with advanced/recurrent or metastatic esophageal squamous cell carcinoma in China: a real-world multicenter study

Yu, L., Shen, W., Ye, J., Luo, H., Zhang, X., Xu, Y., Lin, Q., Liu, W., Zhang, Y., Xu, Y., et al. (2024) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359241297092 · Cited by 3 · see citing works

Clinicopathological and molecular features of claudin-18 isoform 2 expression in patients with colorectal cancer: a single-center retrospective study

Takamizawa, S., Hirano, H., Takashima, A., Shoji, H., Hirose, T., Okita, N. T., Shiraishi, K., Sekine, S., Takamizawa, Y., Kanemitsu, Y., et al. (2024) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359241286774 · Cited by 3 · see citing works

Real-world analysis of HER2-ultralow in HR+/HER2– metastatic breast cancer: prevalence and first-line chemotherapy outcomes

Mathiot, L., Kerdraon, O., Borgne, F. L., Verrièle, V., Patsouris, A., Robert, M., Chetritt, J. J., Loussouarn, D., Campone, M., Bocquet, F., et al. (2025) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359251378863 · Cited by 3 · see citing works

Real-World Evidence in Oncology: Opportunities and Limitations

Maïo, M. D., Perrone, F., & Conte, P. (2019) · The Oncologist · doi:10.1634/theoncologist.2019-0647 · Cited by 176 · see citing works

Pré-test

Pellat, A., & Grinda, T. (2024) · Hépato-Gastro & Oncologie Digestive · doi:10.1684/hpg.2024.2812

Real-world evidence studies in oncology: a trend or a necessity?

Zhuravkov, A., Moiseenko, F. V., Колбин, А. С., & Moiseyenko, V. M. (2023) · Practical oncology · doi:10.31917/2401059 · Cited by 3 · see citing works

Longitudinal trends of real-world evidence (RWE) reporting in oncology conferences: An 11-year ASCO Annual Meeting analysis.

Azad, F., Zhang, J., Akhtar, O. S., George, A. M., Attwood, K. M., & Torka, P. (2022) · Journal of Clinical Oncology · doi:10.1200/jco.2022.40.16_suppl.e18748 · Cited by 1 · see citing works

Editorial: Real-world data and real-world evidence in lung cancer

Gristina, V., & Eze, C. (2024) · Frontiers in Oncology · doi:10.3389/fonc.2024.1436077 · Cited by 9 · see citing works