ESMO Guidance for Reporting Oncology real-World evidence (GROW)

ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions

Sterne, J. A., Hernán, M. A., Reeves, B. C., Savović, J., Berkman, N. D., Viswanathan, M., Henry, D., Altman, D. G., Ansari, M. T., Boutron, I., et al. (2016) · BMJ · doi:10.1136/bmj.i4919 · Cited by 20,329

Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.

Elm, E. V., Altman, D. G., Egger, M., Pocock, S. J., Gøtzsche, P. C., & Vandenbroucke, J. P. (2007) · BMJ · doi:10.1136/bmj.39335.541782.ad · Cited by 10,766

The Reporting of Studies Conducted Using Observational Routinely-Collected Health Data (RECORD) statement.

Benchimol, E. I., Smeeth, L., Guttmann, A., Harron, K., Moher, D., Petersen, I., Sørensen, H. T., von Elm, E., Langan, S. M., & RECORD Working Committee (2015) · PLOS Medicine · doi:10.1371/journal.pmed.1001885 · Cited by 5,749

To Explain or to Predict?

Galit Shmueli, A. (2010) · Statistical Science · doi:10.1214/10-sts330 · Cited by 3,392

Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available: Table 1.

Hernán, M. A., & Robins, J. M. (2016) · American Journal of Epidemiology · doi:10.1093/aje/kwv254 · Cited by 3,115

Statistics versus machine learning

Bzdok, D., Altman, N., & Krzywinski, M. (2018) · Nature Methods · doi:10.1038/nmeth.4642 · Cited by 1,508

Statistics in Medicine — Reporting of Subgroup Analyses in Clinical Trials

Wang, R., Lagakos, S. W., Ware, J. H., Hunter, D. J., & Drazen, J. M. (2007) · New England Journal of Medicine · doi:10.1056/nejmsr077003 · Cited by 1,445

Checklist for Artificial Intelligence in Medical Imaging (CLAIM): a guide for authors and reviewers

Mongan, J., Moy, L., & Kahn, C. E. (2020) · Radiology: Artificial Intelligence · doi:10.1148/ryai.2020200029 · Cited by 1,443

REporting recommendations for tumour MARKer prognostic studies (REMARK).

for the Statistics Subcommittee of the NCI-EORTC Working Group on Cancer Diagnostics, McShane, L. M., Altman, D. G., Sauerbrei, W., Taube, S. E., Gion, M., & Clark, G. M. (2005) · British Journal of Cancer · doi:10.1038/sj.bjc.6602678 · Cited by 1,394

Identifying the PECO: A framework for formulating good questions to explore the association of environmental and other exposures with health outcomes

Morgan, R. L., Whaley, P., Thayer, K. A., & Schünemann, H. J. (2018) · Environment International · doi:10.1016/j.envint.2018.07.015 · Cited by 1,282

Leveraging real-world data in evidence-based caries research: a meta-epidemiological study

Wu, S., Chan, M. K., Lo, E. C. M., & Wong, M. C. M. (2026) · Journal of Evidence Based Dental Practice · doi:10.1016/j.jebdp.2026.102238

Immunotherapy and the Sequence Relative to Survival Outcomes in SCLC: Analysis of the National Cancer Database

Yao, D., Liu, Y., Yu, W., Zheng, S., Huang, L., Cai, M., Zhuang, Y., He, Y.-W., & Huang, X. (2026) · Cancers · doi:10.3390/cancers18040567

Influenza Vaccination Among Patients With Cancer Treated With Checkpoint Inhibitors: Association With Survival Outcomes and Immune-Related Adverse Events

Koliadi, A., Digkas, E., El‐Naggar, A. I., Ullenhag, G. J., & Valachis, A. (2026) · JCO Oncology Practice · doi:10.1200/op-25-00660

Clinical Characteristics, Management Strategies, and Survival of High-Risk Early Hormone Receptor–Positive Breast Cancer in Routine French Practice: Insights from the CANTO Cohort

Dubois, E. B., Chevalier, M. A., & Leclerc, A. J. (2023) · Archive of International Journal of Cancer and Allied Science · doi:10.51847/r8v3h41d5e

Multicenter study of bleeding and thromboembolic events with durvalumab tremelimumab vs. atezolizumab and bevacizumab in advanced HCC

Khaled, N. B., Mohr, R. U., Jochheim, L. S., Zarka, V., Karin, M., Artusa, F., Schütte, J. M., Himmelsbach, V., Ehmer, U., Böttcher, K., et al. (2026) · JHEP Reports · doi:10.1016/j.jhepr.2026.101818

Clinically Meaningful, Patient-Centered Endpoints for Real-World Evidence Generation in Breast Cancer: Perspectives from the Multidisciplinary TRIUMPH Initiative

Khozin, S., Dreyer, N. A., Galante, D., Liu, R., Neumann, P., Nussbaum, N. C., O’Shaughnessy, J., Rimawi, M. F., Rugo, H. S., Tolaney, S. M., et al. (2026) · Advances in Therapy · doi:10.1007/s12325-026-03537-z

Methodological reflections on real‐world electronic health records analyses in oncology

Bjerrum, A. (2026) · International Journal of Cancer · doi:10.1002/ijc.70457

Effectiveness of FTD/TPI plus bevacizumab and impact of prior bevacizumab exposure in patients with mCRC: the Italian FLOWER study

Trovato, G., Carullo, M., Nicastro, A., Spoto, C., Perissinotto, E., Giordano, G., Giacomo, E. D., Calegari, M. A., Pasquinucci, V., Troiani, T., et al. (2026) · ESMO Gastrointestinal Oncology · doi:10.1016/j.esmogo.2026.100317

Unmet need for patients with metastatic triple-negative breast cancer initiating first-line treatment: data from the prospective German tumor registry OPAL

Stickeler, E., Decker, T., Zahn, M.-O., Thill, M. A. M., Zaiss, M., Nusch, A., Teutsch, C., Wang, M., Kuske, A., Ringwald, K., et al. (2026) · ESMO Real World Data and Digital Oncology · doi:10.1016/j.esmorw.2026.100699

Real-World Data on the Effectiveness of Immunotherapy on Advanced NSCLC: A Retrospective Cohort Study

Katsarolis, A., Tapazidou-Spanoudi, I., Kugiumtzis, D., Pastelli, N., Spyratos, D. G., Manika, Κ., Vagionas, A., Lampaki, S., & Fountzilas, E. (2026) · Cancers · doi:10.3390/cancers18081239

ONMORE-Africa: diagnosing and building real-world oncology studies in Morocco and Africa

Tafenzi, H. A., Selmouni, F., Elmarrachi, H., Ismaili, N., Essadi, I., & Belbaraka, R. (2026) · ESMO Real World Data and Digital Oncology · doi:10.1016/j.esmorw.2026.100715

Methodological considerations for centromere copy number analyses in HER2-positive metastatic breast cancer

Zhang, Y. (2026) · Oncogene · doi:10.1038/s41388-026-03793-x

Clinical and Radiometabolic Correlatives of ddPCR Liquid Biopsy for BRAF V600 Mutated Melanoma

Stoff, R., Bilgin, G. B., Nikanpour, Y., Johnson, G. B., Kipp, B. R., Zahrieh, D. M., Geiersbach, K. B., Block, M. S., & Markovic, S. N. (2026) · International Journal of Cancer · doi:10.1002/ijc.70514

Real-world obesity prevalence and history in 79 271 patients receiving systemic anticancer therapy across 13 cancer types in England (2013-2023)

Allan, V., Kulkarni, S., Wang, Z., Tomlinson, J. W., Hippisley‐Cox, J., Collins, G. S., Clift, A. K., Dodwell, D. J., & Lord, S. (2026) · ESMO Real World Data and Digital Oncology · doi:10.1016/j.esmorw.2026.100700

Biliary Tract Carcinoma: Real-World Evidence in a Developing Country

Lema, M., Lema, C., Preciado, B., Duque, S. I. H., Luján, M., Aguirre, D., Bonilla, C. E., Gómez, D., Pérez, E., Pineda, M., et al. (2026) · Cureus · doi:10.7759/cureus.108316

Challenges in the measurement and valuation of oncological treatments in Spain: recommendations and call to action

García-Campelo, M. R., Corral, J., Moreno, F., Munoz, A., Balea, J. M., Barragán, B., Ginés, J., Nicolás, F. G., Sangro, B., Martín-Sánchez, E., et al. (2026) · Clinical & Translational Oncology · doi:10.1007/s12094-026-04323-7

The Relevance of Curative‐Intent Metastasectomy in Colorectal Cancer Patients: Real‐World Insights From a Certified Comprehensive Cancer Center in Germany

Holch, J. W., Eisenburger, J., Weber, A., Wehlau, I. M. M. K., Wiberg, Y., Allmendinger, F., Heinrich, K., Weiss, L., Westphalen, C. B., Krenmayr, V., et al. (2026) · International Journal of Cancer · doi:10.1002/ijc.70540

Eine hohe Adhärenz zur adjuvanten endokrinen Therapie verbessert das Outcome bei frühem Brustkrebs – Ergebnisse aus einer großen Real-World-Datenanalyse in Deutschland

Engler, T., Hartkopf, A. D., Dannehl, D., Dijkstra, T. M. H., Volmer, L. L., Hahn, M., von Au, A., Hawighorst‐Knapstein, S., Chaudhuri, A., Wallwiener, M., et al. (2026) · Senologie - Zeitschrift für Mammadiagnostik und -therapie · doi:10.1055/a-2848-2249

A nationwide population-based study on the incidence and prognosis of HER2-positive breast cancer eligible for adjuvant pertuzumab in the modern era of neoadjuvant therapy

Valachis, A., Liu, X., Ács, B., Hartman, J., Foukakis, T., & Matikas, A. (2026) · The Breast · doi:10.1016/j.breast.2026.104834

Tucatinib in patients with HER2-positive advanced/metastatic breast cancer: A systematic literature review of real-world evidence

Sánchez-Bayona, R., Anders, C., Bartsch, R., Cameron, D., Ciruelos, E. M., Criscitiello, C., Duhoux, F. P., Foukakis, T., Frenel, J., Gligorov, J., et al. (2026) · The Breast · doi:10.1016/j.breast.2026.104837

Real-World Outcomes and Clinical Heterogeneity of First-Line Immunochemotherapy in Extensive-Stage Small-Cell Lung CancerPreprint

Wang, J., Zhong, Y., Chen, B. H., Li, J., Xu, Y., Xu, L. L., Xu, F., Wang, Q., Dai, Z., Yang, S., et al. (2026) · Research Square · doi:10.21203/rs.3.rs-9699215/v1

Long-term outcomes and treatment response in early-stage invasive lobular carcinoma: insights from a nationwide population-based study

Marta, G. N., Ameye, L., Martins-Branco, D. A., Salgado, R., Damme, N. V., Verbeeck, J., Aftimos, P., Buisseret, L., Paesmans, M., Molinelli, C., et al. (2026) · ESMO Open · doi:10.1016/j.esmoop.2026.107731

First-line osimertinib in advanced EGFR-mutated NSCLC: real-world outcomes, clinicogenomic correlates, and oligoprogression management in a multicenter Spanish cohort

Suay, G., Esteban, S. C., Capdevila, P., García-Márquez, A., Garde, J., Espinosa-Olarte, P., Rondan, M. A., Contreras, S. S., Aparisi, F., Escoín, C., et al. (2026) · ESMO Real World Data and Digital Oncology · doi:10.1016/j.esmorw.2026.100725

Management of older adults with colorectal cancer – The state-of-the-art in 2026

Liposits, G. I., André, T., Aparicio, T., Montroni, I., Taı̈eb, J., Gallois, C., Cutsem, E. V., Ducreux, M. P., Pfeiffer, P., Lonardi, S., et al. (2026) · Journal of Geriatric Oncology · doi:10.1016/j.jgo.2026.103054

A Systematic Literature Review of the Effectiveness of CDK 4/6 Inhibitors for First-Line Treatment of HR+/HER2− Advanced/Metastatic Breast Cancer: A Comparison of Real-World Evidence

Pluard, T., Grinda, T., Dienstmann, R., Thill, M., Korytowsky, B., Chen, C. X., Portuhay, S., Salvo‐Halloran, E. M., Samjoo, I. A., & Harbeck, N. (2026) · Cancers · doi:10.3390/cancers18142362

Rethinking evidence generation in gastrointestinal cancer treatment research: the need for both high-quality interventional and observational evidence

Pellat, A., Boutron, I., Porcher, R., Tran, V.-T., & Ravaud, P. (2026) · BMC Medicine · doi:10.1186/s12916-026-05054-w

Early death and early relapse in advanced ovarian cancer: distinct clinical phenotypes in the International SUROVA cohort

Ordás, P., Mishra, J., Ayhan, A., Lee, Y.-Y., Bogani, G., Somashekhar, S. P., Lomnytska, M. I., Stukan, M., Fruscio, R., Chura, B. F., et al. (2026) · International Journal of Gynecological Cancer · doi:10.1016/j.ijgc.2026.104897

Usability and relevance of specialized population-based cancer registry data in externally controlled trials

Jooste, V., Bouvier, A., Lepage, C., Taı̈eb, J., Ganame, S., Ghiringhelli, F., Joseph, A., & Boussari, O. (2026) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2026.112442

Drug exposure definitions reported in real-world evidence studies on oncology medicines in patients with colorectal cancer: a scoping review

van Dommelen, J. E. M., Gardarsdóttir, H., Egberts, T. C. G., & Giezen, T. J. (2026) · ESMO Real World Data and Digital Oncology · doi:10.1016/j.esmorw.2026.100750

Lung-molGPA may stratify the prognostic impact of TP53 co-mutation in EGFR-mutant lung adenocarcinoma with brain metastases: a multi-center retrospective analysis

Deng, G., Zhang, Y., Fan, J., Jiang, Y., Zhao, C., Lin, J., Peng, Y., Li, Z., & Yang, Z. (2026) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359261471117

Prospective, longitudinal oncology registries enabling advanced real-world evidence: the iOMEDICO experience

Jaenicke, M., Dille, S., Frank, M., & Marschner, P. (2026) · ESMO Real World Data and Digital Oncology · doi:10.1016/j.esmorw.2026.100760

Corticosteroid exposure, tapering, and survival in immune-related colitis: a 10-year real-world melanoma cohort

Petersen, S. K., Madley, S., Kjeldsen, J., Bastholt, L., Brink, C., & Ruhlmann, C. H. B. (2026) · Immuno-Oncology Technology · doi:10.1016/j.iotech.2026.101610

Treatment and survival of de novo HER2-positive metastatic breast cancer across regional cancer networks in the Netherlands: a cohort study

Ding, N., Geurts, S. M. E., Hermans, K. E. P. E., Vriens, I. J. H., Visserman, R., Kooreman, L. F. S., Peters, N. A. J. B., Heuts, E. M., Verloop, J., Voogd, A. C., et al. (2026) · ESMO Real World Data and Digital Oncology · doi:10.1016/j.esmorw.2026.100722

Use of real-world evidence in the U.S. Food and Drug Administration and the European Medicines Agency approvals of oncology products supported by single-arm trials (2022-2025)

Su, L., Chen, L., Mamtani, R., Betigeri, S., Hubbard, R. W., & Burcu, M. (2026) · The Oncologist · doi:10.1093/oncolo/oyag296

Association of Prior Local Therapy with Outcomes Within Systemic Therapy Regimen Cohorts in Advanced Soft Tissue Sarcoma: A Retrospective Cohort Study

Ohkuma, R., Ishiguro, T., Ariizumi, H., Shimokawa, M., Ikeda, G., Yoshizawa, T., Hirasawa, Y., Suzuki, R., Tsurui, T., Mura, E., et al. (2026) · Cancers · doi:10.3390/cancers18172806

Real-world characteristics and invasive disease-free survival of resected patients with HR-positive/HER2-negative early breast cancer: evidence from German population-based cancer registries

Grieger, P., Beykloo, M. Y., Lee, C. J., Moreira, J., Niklas, N., Twardella, D., Köpf, B., Reil, D., Schneider, C., Luttmann, S., et al. (2026) · ESMO Real World Data and Digital Oncology · doi:10.1016/j.esmorw.2026.100765

Adjuvant FOLFIRINOX versus S-1 monotherapy for resected PDAC: retrospective real-world data

Tang, H. J., Li, Z., You, T., Ying, J., Cheng, Y., Bai, C., & Wang, Y. (2026) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359261470681

Improved Glioblastoma Survival Across Sweden From 1999 to 2023: Nationwide Analysis Highlights Impact of Demographic and Prognostic Factors When Analysing Regional Variations—A Comprehensive Analysis of 7669 Glioblastoma Patients

Bruhn, H., Tavelin, B., & Henriksson, R. (2026) · Acta Neurologica Scandinavica · doi:10.1155/ane/9958070

Eine hohe Adhärenz zur adjuvanten endokrinen Therapie verbessert das Outcome bei frühem Brustkrebs – Ergebnisse aus einer großen Real-World-Datenanalyse in Deutschland

Engler, T., Hartkopf, A. D., Fetzer, D., Dijkstra, T. M. H., Volme, L., Hahn, M., von Au, A., Hawighorst‐Knapstein, S., Chaudhuri, A., Wallwiener, M., et al. (2026) · Onkologische Welt · doi:10.1055/a-2919-3839

Clinicopathologic and molecular features of head and neck NUT carcinoma: Analysis of 25 cases, including 5 with adenoid differentiation

Yang, Y., Hao, Y., Xu, C., Li, Y., Li, X., Liu, H., & Piao, Y. (2026) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359261490610

A Prospective Study on the Financial Impact of Breast Cancer Treatment over a 1-Year Period for Patients at a Rural Cancer Center

Manko, C. D., Khan, K., Zlupko, T. J., Witteveen, N., Thresher, E., Panek, J., Inamdar, A., Albright, J., & Perry-Keaty, C. (2026) · The Guthrie Clinic Journal of Medicine · doi:10.3138/guthrie-2025-0012

Real-World Evidence as a Driver of Precision Oncology and Personalized Therapeutic Sequencing in Later-Line Metastatic Colorectal Cancer

Signorelli, C. (2026) · Cancers · doi:10.3390/cancers18193174

Understanding Genomic Instability Score in Platinum-Treated Advanced Pancreatic Ductal Adenocarcinoma

Leinhos, J., Malli, T., Gabler, A., Nothdurfter, D., Reichinger, A., Burghofer, J., Schwarz, S., Mandl, J., Schreil, G., Andorfer, A., et al. (2026) · Journal of Clinical Medicine · doi:10.3390/jcm15197632

Artificial intelligence and anti-cancer drugs: advancing discovery, personalization, and precision oncology

Nagrami, F. U. H., Shukla, P., Yadav, R., & Prakash, J. (2026) · Frontiers in Oncology · doi:10.3389/fonc.2026.1885312

The ESMO Scale for Clinical Actionability of Molecular Targets, version 2 (ESCAT v2): an evidence-based framework for ranking alterations as actionability and resistance biomarkers in precision oncology

Helali, A. E., Cardone, C., Coleman, N., Beal, J. R., Cruz-Ordinario, M. V. B., Kocakavuk, E., Chiu, M. K.-L., Thomas, D. M., Turnbull, C., Meric‐Bernstam, F., et al. (2026) · Annals of Oncology · doi:10.1016/j.annonc.2026.09.008

Real-world utilization of pembrolizumab dosing schedules in Belgium: a multi-center retrospective study using a common data model and natural language processing

Verbiest, A., Prenen, H., Janssens, A., Vulsteke, C., Delombaerde, D. L., Tack, L., Debruyne, P. R., Bassez, I., Oeste, C. L., Brandtmuller, A., et al. (2026) · Journal of Comparative Effectiveness Research · doi:10.57264/cer-2026-0011

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 181

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

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

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