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ATLAS Project Research Members

National Cancer Center Hospital (Tokyo, Japan)

NAKAMURA Kenichi (Department of International Clinical Development)



Dr. NAKAMURA's story

Dr. Nakamura is the director of the Department of International Clinical Development and the project leader of the ATLAS project. He also serves as the director of the Japan Clinical Oncology Group (JCOG) Operations Office. He has a lot of experience to manage various types of clinical trials ranging from early-phase investigator-initiated registration directed trials to large-scale pragmatic trials. As a specialist of clinical trial operation and regulation, he engages in several international projects such as the revision of ICH-GCP, collaborative studies with EORTC and IRCI, research ethics project on CRIGH.

Research interests

Clinical trial methodology, operation and regulation.

Professional Experiences

  • 2020-present Director, Department of International Clinical Development, National Cancer Center Hospital
  • 2017-present Chief Management Officer, Clinical Research Support Office, National Cancer Center Hospital
  • 2008-present Director, Japan Clinical Oncology Group Operations Office
  • 2017-2020 Division Chier, Research Management Division, Clinical Research Support Office, National Cancer Center Hospital
  • 2015-2017 Section Head, Clinical Trial Management Section, Clinical Research Support Office, National Cancer Center Hospital

Selected publications

  1. Hata T, Nakamura K, Yonemori K, Noguchi E, Watanabe M, Sohn J, Lu YS, Yap YS, Tamura K, Fuiwara Y. Regulatory and Operational Challenges in Conducting Asian International Academic Trial for Expanding the Indications of Cancer Drugs. Clin Transl Sci. 2021;14:1015-1025.
  2. Okuma HS, Yonemori K, Narita SN, Sukigara T, Hirakawa A, Shimizu T, Shibata T, Kawai A, Yamamoto N, Nakamura K, Nishida T, Fujiwara Y. MASTER KEY Project: Powering Clinical Development for Rare Cancers Through a Platform Trial. Clin Pharmacol Ther. 2020;108:596-605.
  3. Nakamura K, Shibata T. Regulatory changes after the enforcement of the new Clinical Trials Act in Japan. Jpn J Clin Oncol 2020; 50: 399-404.
  4. Nakamura K, Maruyama D. What is the value of health-related quality of life in a negative superiority trial? Ann Oncol 2020; 31: 976-977.
  5. Nakada H, Hasthorpe S, C IJ, Kombe F, Ba M, Matei M, Nakamura K, Ushirozawa N, Fujiwara Y, Tashiro S. Recommendations for promoting international multi-site clinical trials-from a viewpoint of ethics review. Dev World Bioeth 2019; 19: 192-195.
  6. Nakamura K, Fukuda H, Ohashi Y. Cooperative Groups: A Japanese Perspective. In Willian K Kelly SH (ed) Oncology Clinical Trials: successful design, conduct an analysis, Second Edition Edition. New York: Demos Medical Publishing 2018; 463-475.
  7. Fujitani K, Yang HK, Mizusawa J, Kim YW, Terashima M, Han SU, Iwasaki Y, Hyung WJ, Takagane A, Park DJ, Yoshikawa T, Hahn S, Nakamura K, Park CH, Kurokawa Y, Bang YJ, Park BJ, Sasako M, Tsujinaka T, investigators Rs. Gastrectomy plus chemotherapy versus chemotherapy alone for advanced gastric cancer with a single non-curable factor (REGATTA): a phase 3, randomised controlled trial. Lancet Oncol 2016; 17: 309-318.
  8. Evrard S, Audisio R, Poston G, Caballero C, Kataoka K, Fontein D, Collette L, Nakamura K, Fukuda H, Lacombe D. From a Comic Opera to Surcare an Open Letter to Whom Clinical Research in Surgery Is a Concern: Announcing the Launch of SURCARE. Ann Surg 2016; 264: 911-912.
  9. Nakamura K, Kuwata T, Shimoda T, Mizusawa J, Katayama H, Kushima R, Taniguchi H, Sano T, Sasako M, Fukuda H. Determination of the optimal cutoff percentage of residual tumors to define the pathological response rate for gastric cancer treated with preoperative therapy (JCOG1004-A). Gastric Cancer 2015; 18: 597-604.
  10. Nakamura K, Shibata T, Takashima A, Yamamoto S, Fukuda H. Evaluation of three definitions of progression-free survival in preoperative cancer therapy (JCOG0801-A). Jpn J Clin Oncol 2012; 42: 896-902.