Kengo Nagashima, Ph.D.

I am a Project Associate Professor at Keio University.

My research interests are Survival Analysis, Meta-analysis, Causal Inference, Bayesian Inference, and Diagnostic Statistics.

I am also interested in Biomarkers in Clinical Trials, Cancer Clinical Trials, Adaptive Designs, Model Selection, Model Misspecification, Categorical Data Analysis, Exact Methods, Statistical Softwares, Missing Data, Semiparametric Models, Estimating Equations, Inference for High-dimensional Data, Statistical Machine Learning, Genetic Epidemiology, Population Pharmacokinetics, and Quasi-Monte Carlo Integration.

Curriculum vitae (PDF)

Logo: Keio University

Contact Informations

Biostatistics Unit, Clinical and Translational Research Center, Keio University Hospital.
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
E-mail:
Website: https://nshi.jp/en/

Education

Professional Positions

  • Visiting Scientist, Department of Translational Oncology, National Cancer Center Research Institute, November 2021–present.
  • Project Associate Professor, Biostatistics Unit, Clinical and Translational Research Center, Keio University Hospital, April 2021–present.
  • Visiting Associate Professor, Research Center for Medical and Health Data Science, The Institute of Statistical Mathematics, April 2021–present.
  • Lecturer (part-time), Nippon Medical School, April 2021–present.
  • Lecturer (part-time), Graduate School of Engineering, Tokyo University of Science, April 2016–present.
  • Visiting Scientist, Department of Biomarkers for the Early Detection of Cancer, National Cancer Center Research Institute, September 2019–August 2021.
  • Lecturer (part-time), Keio University School of Medicine, April 2019–March 2021.
  • Visiting Associate Professor, Keio University School of Medicine, Nobember 2018–March 2021.
  • Project Associate Professor, Research Center for Medical and Health Data Science, The Institute of Statistical Mathematics, April 2018–March 2021.
  • Research Assistant Professor, Department of Global Clinical Research, Graduate School of Medicine, Chiba University, April 2015–March 2018.
  • Research Assistant Professor, Clinical Research Center, Chiba University Hospital, April 2013–March 2015.
  • Research Associate, Faculty of Pharmaceutical Sciences, Josai University, April 2008–March 2013.

Paper(s) Under Review

  1. Uwamino Y*, Nagashima K*, Yoshifuji A, Suga S, Nagao M, Fujisawa T, Ryuzaki M, Takemoto Y, Namkoong H, Wakui M, Matsushita H, Hasegawa N, Sato Y, Murata M. Estimating immunity with mathematical models for SARS-CoV-2 after COVID-19 vaccination. Under review. DOI: 10.21203/rs.3.rs-1822996. (*equally contributed)

Selected Publications (Peer-Reviewed)

    Statistical Methodology and Applications in Biostatistics

  1. Gosho M, Ohigashi T, Nagashima K, Ito Y, Maruo K. Bias in odds ratios from logistic regression methods with sparse data set. Journal of Epidemiology 2022+. In press. DOI: 10.2188/jea.JE20210089.
  2. Noma H, Nagashima K, Kato S, Teramukai S, Furukawa TA. Flexible random-effects distribution models for meta-analysis. Journal of Epidemiology 2022;32(10):441–448. DOI: 10.2188/jea.JE20200376. [arXiv:2003.04598]
  3. Hamaguchi Y, Noma H, Nagashima K, Yamada T, Furukawa TA. Frequentist performances of Bayesian prediction intervals for random-effects meta-analysis. Biometrical Journal 2021;63(2):394–405. DOI: 10.1002/bimj.201900351. [arXiv:1907.00345]
  4. Nagashima K, Noma H, Sato Y, Gosho M. Sample size calculations for single-arm survival studies using transformations of the Kaplan–Meier estimator. Pharmaceutical Statistics 2021;20(3):499–511. DOI: 10.1002/pst.2090. [arXiv:2012.03355]
  5. Noma H, Nagashima K, Furukawa TA. Permutation inference methods for multivariate meta-analysis. Biometrics 2020;76(1):337–347. DOI: 10.1111/biom.13134. [arXiv:1809.03935]
  6. Nagashima K, Noma H, Furukawa TA. Prediction intervals for random-effects meta-analysis: a confidence distribution approach. Statistical Methods in Medical Research 2019;28(6):1689–1702. DOI: 10.1177/0962280218773520. [arXiv:1804.01054] [Software]
  7. Noma H, Nagashima K, Maruo K, Gosho M, Furukawa TA. Bartlett-type corrections and bootstrap adjustments of likelihood-based inference methods for network meta-analysis. Statistics in Medicine 2018;37(7):1178–1190. DOI: 10.1002/sim.7578.
  8. Sato Y, Gosho M, Nagashima K, Takahashi S, Ware JH, Laird NM. Statistical methods in the Journal — an update. New England Journal of Medicine 2017;376(11):1086–1087. DOI: 10.1056/NEJMc1616211. (Correspondence)
  9. Nagashima K, Sato Y. Information criteria for Firth's penalized partial likelihood approach in Cox regression models. Statistics in Medicine 2017;36(21):3422–3436. DOI: 10.1002/sim.7368. [Postprint]
  10. Nagashima K, Sato Y, Noma H, Hamada C. An efficient and robust method for analyzing population pharmacokinetic data in genome-wide pharmacogenomic studies: a generalized estimating equation approach. Statistics in Medicine 2013;32(27):4838–4858. DOI: 10.1002/sim.5895. [arXiv:1805.05017]
  11. Nagashima K, Sato Y, Hamada C. A modified maximum contrast method for unequal sample sizes in pharmacogenomic studies. Statistical Applications in Genetics and Molecular Biology 2011;10(1):Article 41. DOI: 10.2202/1544-6115.1560. [Postprint] [Software]
  12. Medical Researches

  13. Matsumura T, Ebigbo A, Römmele C, Ikematsu H, Ishigami H, Suzuki T, Harada H, Yada T, Takatori Y, Takeuchi M, Okimoto K, Akizue N, Maruoka D, Kitagawa Y, Minamide T, Iwaki T, Amano Y, Matsusaka K, Nagashima K, Maehata T, Yahagi N, Messmann H, Kato N. Diagnostic value of adding magnifying chromoendoscopy to magnifying narrow-band imaging endoscopy for colorectal polyps. Clinical Gastroenterology and Hepatology 2023. In press.
  14. Yamaguchi Y, Takashima A, Nagashima K, Kumagai K, Yamada T, Terashima M, Yabusaki H, Nishikawa K, Tanabe K, Yunome G, Kawachi Y, Yamada T, Fukagawa T, Kinoshita T, Watanabe M, Ishiyama K, Inoue K, Boku N. Evaluating the efficacy of post-operative chemotherapy after curative resection of stage IV gastric cancer with synchronous oligo metastasis: a multicenter retrospective study. Gastric Cancer 2023. In press. DOI: 10.1007/s10120-023-01363-8.
  15. Aoki M, Kadowaki S, Takahashi N, Suzuki T, Oshima K, Ando T, Yamamoto Y, Kawakami K, Kito Y, Matsumoto T, Shimozaki K, Miyazaki Y, Yamaguchi T, Nagase M, Tamura T, Amanuma Y, Esaki T, Miura Y, Akiyoshi K, Baba E, Makiyama A, Negoro Y, Nakashima K, Sugimoto N, Nagashima K, Shoji H, Boku N. Pattern of disease progression during third-line or later chemotherapy with nivolumab associated with poor prognosis in advanced gastric cancer: a multicenter retrospective study in Japan. Gastric Cancer 2022. In press. DOI: 10.1007/s10120-022-01349-y.
  16. Hashimoto T, Takayanagi D, Yonemaru J, Naka T, Nagashima K, Yatabe Y, Shida D, Hamamoto R, Kleeman SO, Leedham SJ, Maughan T, Takashima A, Shiraishi K, Sekine S. Clinicopathological and molecular characteristics of RSPO fusion-positive colorectal cancer. British Journal of Cancer 2022. In press. DOI: 10.1038/s41416-022-01880-w.
  17. Kobayashi K, Ogasawara S, Takahashi A, Seko Y, Unozawa H, Sato R, Watanabe S, Moriguchi M, Morimoto N, Tsuchiya S, Iwai K, Inoue M, Ogawa K, Ishino T, Iwanaga T, Sakuma T, Fujita N, Kanzaki H, Koroki K, Nakamura M, Kanogawa N, Kiyono S, Kondo T, Saito T, Nakagawa R, Suzuki E, Ooka Y, Nakamoto S, Tawada A, Chiba T, Arai M, Kanda T, Maruyama H, Nagashima K, Kato J, Isoda N, Aramaki T, Itoh Y, Kato N. Evolution of survival impact of molecular target agents in patients with advanced hepatocellular carcinoma. Liver Cancer 2022;11(1):48–60. DOI: 10.1159/000519868.
  18. Felix K, Honda K, Nagashima K, Kashiro A, Takeuchi K, Kobayashi T, Hinterkopf S, Gaida MM, Dang H, Brindl N, Kaiser J, Büchler MW, Strobel O. Non-invasive risk stratification of IPMN with malignant potential by serum apolipoprotein-A2-isoforms. International Journal of Cancer 2022;150(5):881–894. DOI: 10.1002/ijc.33875.
  19. Honda K, Hishiki T, Yamamoto S, Yamamoto T, Miura N, Kubo A, Itoh M, Chen W-Y, Takano M, Yoshikawa T, Kasamatsu T, Sonoda S, Yoshizawa H, Nakamura S, Itai Y, Shiota M, Koike D, Naya M, Hayakawa N, Naito Y, Matsuura T, Iwaisako K, Masui T, Uemoto S, Nagashima K, Hashimoto Y, Sakuma T, Matsubara O, Huang W, Ida T, Akaike T, Masugi Y, Sakamoto M, Kato T, Ino Y, Yoshida H, Tsuda H, Hiraoka N, Kabe Y, Suematsu M. On-tissue polysulfide visualization by surface-enhanced Raman spectroscopy benefits patients with ovarian cancer to predict post-operative chemosensitivity. Redox Biology 2021;41:101926. DOI: 10.1016/j.redox.2021.101926.
  20. Yamaguchi T, Takashima A, Nagashima K, Terashima M, Aizawa M, Ohashi M, Tanaka R, Yamada T, Kinoshita T, Inada T, Ishiyama K, Ema A, Yuasa Y, Haruta S, Kakihara N, Nishikawa K, Yunome G, Satoh T, Fukagawa T, Katai H, Boku N. Impact of preoperative chemotherapy as initial treatment for advanced gastric cancer with peritoneal metastasis limited to positive peritoneal lavage cytology (CY1) or localized peritoneal metastasis (P1a): A multi-institutional retrospective study. Gastric Cancer 2021;24(3):701–709. DOI: 10.1007/s10120-020-01137-6.
  21. Ueshima K, Ogasawara S, Ikeda M, Yasui Y, Terashima T, Yamashita T, Obi S, Sato S, Aikata H, Ohmura T, Kuroda H, Ohki T, Nagashima K, Ooka Y, Takita M, Kurosaki M, Chayama K, Kaneko S, Izumi N, Kato N, Kudo M, Omata M. Hepatic arterial infusion chemotherapy versus sorafenib in patients with advanced hepatocellular carcinoma. Liver Cancer 2020;9(5):583–595. DOI: 10.1159/000508724.
  22. Koshizaka M, Ishikawa K, Ishibashi R, Maezawa Y, Sakamoto K, Uchida D, Nakamura S, Yamaga M, Yokoh H, Kobayashi A, Onishi S, Kobayashi K, Ogino J, Hashimoto N, Tokuyama H, Shimada F, Ohara E, Ishikawa T, Shoji M, Ide S, Ide K, Baba Y, Hattori A, Kitamoto T, Horikoshi T, Shimofusa R, Takahashi S, Nagashima K, Sato Y, Takemoto M, Newby LK, Yokote K, On behalf of the PRIME-V study group. Comparing the effects of ipragliflozin versus metformin on visceral fat reduction and metabolic dysfunction in Japanese patients with type 2 diabetes treated with sitagliptin: A prospective, multicentre, open-label, blinded-endpoint, randomised controlled study (PRIME-V study). Diabetes, Obesity and Metabolism 2019;21(8):1990–1995. DOI: 10.1111/dom.13750.
  23. Misawa S, Kuwabara S, Sato Y, Yamaguchi N, Nagashima K, Katayama K, Sekiguchi Y, Iwai Y, Amino H, Suichi T, Yokota T, Nishida Y, Kanouchi T, Kohara N, Kawamoto M, Ishii J, Kuwahara M, Suzuki H, Hirata K, Kokubun N, Masuda R, Kaneko J, Yabe I, Sasaki H, Kaida K-i, Takazaki H, Suzuki N, Suzuki S, Nodera H, Matsui N, Tsuji S, Koike H, Yamasaki R, Kusunoki S, for the Japanese Eculizumab Trial for GBS (JET-GBS) Study Group. Safety and efficacy of eculizumab in Guillain–Barré syndrome: a multicentre, double-blind, randomised phase 2 trial. The Lancet Neurology 2018;17(6):519–529. DOI: 10.1016/S1474-4422(18)30114-5.
  24. Watanabe K, Hirano S, Kojima K, Nagashima K, Mukai H, Sato T, Takemoto M, Matsumoto K, Iimori T, Isose S, Omori S, Shibuya K, Sekiguchi Y, Beppu M, Amino H, Suichi T, Yokote K, Uno T, Kuwabara S, Misawa S. Altered cerebral blood flow in the anterior cingulate cortex is associated with neuropathic pain. Journal of Neurology, Neurosurgery, and Psychiatry 2018;89(10):1082–1087. DOI: 10.1136/jnnp-2017-316601.
  25. Sasaki Y, Iwasa S, Okazaki S, Goto M, Kojima Y, Naganuma A, Nagashima K, Nagai Y, Hirano H, Honma Y, Takashima A, Kato K, Hamaguchi T. A phase II study of combination therapy with oral S-1 and cisplatin in elderly patients with advanced gastric cancer. Gastric Cancer 2018;21(3):439–445. DOI: 10.1007/s10120-017-0753-2.
  26. Yanai T, Iwasa S, Hashimoto H, Ohyanagi F, Takiguchi T, Takeda K, Nakao M, Sakai H, Nakayama T, Minato K, Arai T, Suzuki K, Shimada Y, Nagashima K, Terakado H, Yamamoto N. A double-blind randomized phase II dose-finding study of olanzapine 10 mg or 5 mg for the prophylaxis of emesis induced by highly emetogenic cisplatin-based chemotherapy. International Journal of Clinical Oncology 2018;23(2):382–388. DOI: 10.1007/s10147-017-1200-4.
  27. Nishimura T, Iwasa S, Nagashima K, Okita N, Takashima A, Honma Y, Kato K, Hamaguchi T, Yamada Y, Shimada Y, Boku N. Irinotecan monotherapy as third-line treatment for advanced gastric cancer refractory to fluoropyrimidines, platinum, and taxanes. Gastric Cancer 2017;20(4):655–662. DOI: 10.1007/s10120-016-0670-9.
  28. Yamamoto Y, Yamaguchi S, Sasho T, Fukawa T, Akatsu Y, Akagi R, Yamaguchi T, Takahashi K, Nagashima K, Takahashi K. Quantitative US elastography can quantify mechanical and histological tendon healing in a rabbit model of achilles tendon transection. Radiology 2017;283(2):408–417. DOI: 10.1148/radiol.2016160695.
  29. Misawa S, Sato Y, Katayama K, Nagashima K, Aoyagi R, Sekiguchi Y, Sobue G, Koike H, Yabe I, Sasaki H, Watanabe O, Takashima H, Nishizawa M, Kawachi I, Kusunoki S, Mitsui Y, Kikuchi S, Nakashima I, Ikeda S-i, Kohara N, Kanda T, Kira J-i, Hanaoka H, Kuwabara S, for the Japanese POEMS Syndrome for Thalidomide (J-POST) Trial Study Group. Safety and efficacy of thalidomide in patients with POEMS syndrome: a multicentre, randomised, double-blind, placebo-controlled trial. The Lancet Neurology 2016;15(11):1129–1137. DOI: 10.1016/S1474-4422(16)30157-0.
  30. Tada K, Kitano S, Shoji H, Nishimura T, Shimada Y, Nagashima K, Aoki K, Hiraoka N, Honma Y, Iwasa S, Okita N, Takashima A, Kato K, Yamada Y, Katayama N, Boku N, Heike Y, Hamaguchi T. Pretreatment immune status correlates with progression-free survival in chemotherapy-treated metastatic colorectal cancer patients. Cancer Immunology Research 2016;4(7):592–599. DOI: 10.1158/2326-6066.CIR-15-0298.

Full publication list: Curriculum vitae (PDF)

Preprint(s)

  1. Nagashima K, Noma H, Furukawa TA. pimeta: an R package of prediction intervals for random-effects meta-analysis. [arXiv:2110.07856]

Funding History

    Biostatistics

  1. Statistical inference for random-effects meta-analyses under model misspecification. Japan Society for the Promotion of Science (JSPS) KAKENHI, Grant-in-Aid for Young Scientists. April 2019–March 2022. Grant number: 19K20229. (PI)
  2. Developments of statistical inference, prediction, and modeling methods for network meta-analysis. Japan Society for the Promotion of Science (JSPS) KAKENHI, Grant-in-Aid for Scientific Research (B). April 2019–March 2020. Grant number: 19H04074. (Co-I)
  3. Statistical inference for rare event data and its application in clinical researches. Japan Society for the Promotion of Science (JSPS) KAKENHI, Grant-in-Aid for Young Scientists (B). April 2016–March 2019. Grant number: 16K16014. (PI)
  4. Medical Researches

  5. Development of early detection biomarkers for gastroenterological cancer by antibody-based comprehensive screening. Japan Agency for Medical Research and Development, Project for Promotion of Cancer Research and Therapeutic Evolution (P-PROMOTE). April 2022–March 2024. (Co-I)
  6. Clinical development of a diagnostic method for early-stage pancreatic cancer and risk factors for pancreatic cancer malignancy using a blood biomarker to evaluate a pancreatic exocrine function. Japan Agency for Medical Research and Development, Practical Research for Innovative Cancer Control. April 2021–March 2026. (Co-I)
  7. Study for clinical development of precision medicine for esophageal cancer. Japan Agency for Medical Research and Development, Project for Cancer Research and Therapeutic Evolution (P-CREATE). April 2021–March 2025. (Co-I)
  8. Health literacy improvement of cervical cancer prevention using information and communications technology. Japan Society for the Promotion of Science (JSPS) KAKENHI, Challenging Research (Exploratory). July 2019–March 2022. Grant number: 19K22737. (Co-I)
  9. Practical application of efficient pancreatic cancer screening with plasma biomarker. Japan Agency for Medical Research and Development, Practical Research for Innovative Cancer Control. December 2018–March 2020. (Co-I)
  10. Practical research of blood biomarkers for predicting effects of postoperative adjuvant chemotherapies by metastatic activity analysis of non-small cell lung cancer. Japan Agency for Medical Research and Development, Practical Research for Innovative Cancer Control. April 2017–March 2020. (Co-I)
  11. Developing an early-detection and risk-stratification biomarkers for cancer by analyzing post-translational modifications to proteins and peptides. Japan Agency for Medical Research and Development, Project for Cancer Research and Therapeutic Evolution (P-CREATE). April 2017–March 2022. (Co-I)
  12. Evaluation study for efficacy and safety of drug therapy based on sex differences. Japan Agency for Medical Research and Development, Project for Whole Implementation to Support and Ensure the female life—Wise. November 2016–March 2019. (Co-I)
  13. Development of efficient screening method for early detection and risk stratification of pancreatic cancer. Japan Agency for Medical Research and Development, Practical Research for Innovative Cancer Control. September 2016–March 2017. (Co-I)

Teaching History

  • Biostatistics and medical informatics, School of Medicine, Keio University, 2022–present.
  • Public health II, School of Medicine, Keio University, 2022–present.
  • Biostatistics, Graduate School of Health Management, Keio University, 2021–present.
  • Design and analysis of clinical trials, Graduate School of Health Management, Keio University, 2019–present.
  • Linear statistical inference, Graduate School of Engineering, Tokyo University of Science, 2016–present.
  • Introduction of clinical research, Graduate School of Medical and Pharmaceutical Sciences, Chiba University, 2014.
  • Principles of biostatistics, Graduate School of Medical and Pharmaceutical Sciences, Chiba University, 2010–2018.

Professional Activities

Editorial Role

  • Associate Editor: Japanese Journal of Biometrics, 2023–present.
  • Associate Editor: Japanese Journal of Statistics and Data Science, 2023–present.

Professional Affiliations

  • Member, American Statistical Association, 2011–present.
  • Member, The International Biometric Society, 2008–present.

Journal Reviewer

    Statistics Journal

  • Statistics in Medicine
  • Journal of the Royal Statistical Society: Series C (Applied Statistics)
  • Biometrical Journal
  • Research Synthesis Methods
  • Annals of the Institute of Statistical Mathematics
  • Statistics in Biopharmaceutical Research
  • Biostatistics & Epidemiology
  • Entropy
  • Journal of Statistical Computation and Simulation
  • Statistical Applications in Genetics and Molecular Biology
  • BMC Bioinformatics
  • Japanese Journal of Statistics and Data Science
  • Behaviormetrika
  • Stats
  • Mathematics
  • Medical Journal

  • European Journal of Epidemiology
  • Cancer Science
  • Esophagus
  • Diabetes, Obesity and Metabolism
  • Expert Review of Respiratory Medicine
  • Epidemiology and Infection
  • Sleep Medicine
  • Trials
  • PLoS ONE
  • BMJ Open
  • Nanomedicine
  • Cancer Biomarkers
  • Asia-Pacific Journal of Clinical Oncology
  • Journal of Clinical Pharmacy and Therapeutics
  • International Journal of Environmental Research and Public Health

Softwares

Links

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