教授 平川 晃弘 Akihiro Hirakawa

教授 平川 晃弘

博士（工学）

学内研究者情報データベース

略歴

2004.4 - 2006.3
東京理科大学大学院工学研究科経営工学専攻 修士課程
2006.4 - 2011.3
（独）医薬品医療機器総合機構 新薬審査第一部・第五部 審査専門員
2008.4 - 2011.3
東京理科大学大学院工学研究科経営工学専攻 博士課程
2011.4 - 2012.3
東京理科大学工学部経営工学科 助教
2012.4 - 2017.3
名古屋大学医学部附属病院 先端医療・臨床研究支援センター 講師（統計解析室 室長）
2017.4 - 2020.3
東京大学大学院医学系研究科 生物統計情報学講座 特任准教授
2020.4 -                 
東京医科歯科大学 病院 臨床試験管理センター / 大学院医歯学総合研究科 臨床統計学分野 教授

統計手法に関する論文

  1. Asano J, Sato H, Hirakawa A. Practical basket design for binary outcomes with control of family-wise error rate. BMC Medical Research Methodology, 23:52,doi: https://doi.org/10.1186/s12874-023-01872-1, 2023     
  2. Hirakawa A, Sato H, Hanazawa R, Suzuki K; Japanese Alzheimer's Disease Neuroimaging Initiative. Estimating the longitudinal trajectory of cognitive function measurement using short-term data with different disease stages: Application in Alzheimer's disease. Statistics in Medicine. 41(21):4200-4214, doi: 10.1002/sim.9504. 2022.    
  3.  Hirakawa A, Sato H, Igeta M, Fujikawa K, Daimon T, Teramukai S. Regulatory issues and the potential use of Bayesian approaches for early drug approval systems in Japan. Pharmaceutical Statistics, 21: 691-695, 2022.    
  4. Kaneko S, Hirakawa A (corresponding author). Assessment of overall treatment effect in the presence of inconsistent regional effects in multiregional clinical trials. Statistics in Biopharmaceutical Research. doi:10.1080/19466315.2021.1845233,2020    
  5. Asano J, Hirakawa A (corresponding author). A Bayesian basket trial design accounting for uncertainties of homogeneity and heterogeneity of treatment effect among subpopulations. Pharmaceutical Statistics 2020 19(6):975-1000,2020    
  6. Kaneko S, Hirakawa A, Kakurai Y, Hamada C. A dose-finding approach for genomic patterns in phase I trials. Journal of Biopharmaceutical Statistics. 2020.     
  7. Hirakawa A, Tanaka Y, Kaneko S. Pragmatic dose-escalation methods incorporating relative dose intensity assessment for molecularly targeted agents in phase I trials. Contemporary Clinical Trial Communications. https://doi.org/10.1016/j.conctc.2019.100489, 2019.     
  8. Hirakawa A, Sudo K, Yonemori K, Sadachi R, Kinoshita F, Kobayashi Y, Okuma SH, Kawachi A, Tamura K, Fujiwara Y, Rubinstein L, Takebe N. A comparative study of longitudinal toxicities of cytotoxic drugs, molecularly targeted agents, immunomodulatory drugs, and cancer vaccines. Clinical Pharmacology & Therapeutics. 106:803-809, 2019. 
  9. Kakurai Y, Kaneko S, Hamada C, Hirakawa A (corresponding author). Dose individualization and variable selection using Bayesian Lasso in early phase dose-finding trials. Applied Statistics. 68:445-460, 2019.     
  10. Hirakawa A, Hatakeyama T, Kobayashi D, Nishiyama C, Kada A, Kiguchi T, Kawamura T, Iwami T. Real-time feedback, debriefing, and retraining system of cardiopulmonary resuscitation for out-of-hospital cardiac arrests: study protocol for a randomized controlled trial. Trials. 19 :510, 2018.     
  11. Hirakawa A, Asano J, Sato H, Teramukai S. Master protocol trials in oncology: Review and new trial designs. Contemporary Clinical Trial Communications, 12:1-8, 2018.     
  12. Hirakawa A, Nishikawa T, Yonemori K, Shibata T, Nakamura K, Ando M, Ueda T, Ozaki T, Tamura K, Kawai A, Fujiwara Y. Utility of Bayesian single-arm design in new drug application for rare cancers in Japan: a case study of phase 2 trial for sarcoma. Therapeutic Innovation & Regulatory Science, 52:334-338, 2018.     
  13. Shimamura F, Hamada C, Matsui S, Hirakawa A(corresponding author). Two-stage approach based on zone and dose findings for two-agent combination Phase I/II trials. Journal of Biopharmaceutical Statistics, 18:1-13, 2018.     
  14. Hirakawa A, Yonemori K, Kinoshita F, Kobayashi Y, Okuma H. Kawachi A, Tamura K, Fujiwara Y, Rubinstein L, Harris PJ, Takebe N. Potential utility of a longitudinal relative dose intensity of molecularly targeted agents in phase 1 dose-finding trial. Cancer Science, 109:207-214, 2018.     
  15. Hirakawa A, Kinoshita F. An analysis of Japanese patients enrolled into multiregional clinical trials in oncology. Therapeutic Innovation & Regulatory Science, 51: 207–211, 2017.     
  16. Nomura S, Hirakawa A, Hamada C. Sample size determination for the current strategy in oncology phase 3 trials that tests progression-free survival and overall survival in a two-stage design framework. Journal of Biopharmaceutical Statistics, 8: 1-23, 2017.     
  17. Shimura M, Gosho M, Hirakawa A. Comparison of conditional bias-adjusted estimators for interim analysis in clinical trials with survival data. Statistics in Medicine, 36:2067-2080, 2017.     
  18. Asano J, Hirakawa A (co-first author). Assessing the prediction accuracy of a cure model for censored survival data with long-term survivors: application to breast cancer data. Journal of Biopharmaceutical Statistics, 1-15, doi: 10.1080/10543406.2017.1293082, 2017 Feb 13.     
  19. Gosho M, Maruo K, Tada K, Hirakawa A. Utilization of chi-square statistics for screening adverse drug-drug interactions in spontaneous reporting systems. European Journal of Clinical Pharmacology, 73: 779-786, 2017.     
  20. Gosho M, Maruo K, Ishii R, Hirakawa A. Analysis of an incomplete longitudinal composite variable using a marginalized random effects model and multiple imputation. Statistical Methods in Medical Research, DOI: 10.1177/0962280216677879, 2016.     
  21. Hirakawa A, Sato H, Gosho M. Effect of design specifications in dose-finding trials for combination therapies in oncology. Pharmaceutical Statistics, 15: 531-540, 2016.     
  22. Yonemori K, Hirakawa A (co-first author), Kawachi A, Kinoshita F, Ohkuma H, Nishikawa T, Kenji T, Fujiwara Y, Takebe N. Drug induced Interstitial Lung Disease in Oncology Phase I Trials. Cancer Science, 107(12):1830-1836, 2016.     
  23. Sato H, Hirakawa A (co-first author), Hamada C. An adaptive dose-finding method using a change-point model for molecularly targeted agents in phase I trials. Statistics in Medicine, 35:4093-4109, 2016.     
  24. Hirakawa A, Sato H. Authors' Reply: Response to Letter to the Editor by Drs Riviere et al. Statistics in Medicine, 35: 479-480, 2016.     
  25. Gosho M, Hirakawa A, Maruo K, Noma H, Sato Y. Comparison of bias-corrected covariance estimators for MMRM analysis in longitudinal data with dropouts. Statistical Method in Medical Research, doi: 10.1177/0962280215597938, 2015.     
  26. Hirakawa A and Matsui S. Operating characteristics of restrictions on skipping dose level for adaptive dose-finding method in two-agent phase I trials. Japanese Journal of Biometrics, 36:1-12, 2015.     
  27. Kakurai Y, Hirakawa A, Hamada C. A dose-finding method based on multiple dosing in two-agent combination phase I trials. Journal of Biopharmaceutical Statistics, 25:1065-1076, 2015.     
  28. Kaneko S, Hirakawa A, Hamada C. Enhancing the lasso approach for developing a survival prediction model based on gene expression data. Computational and Mathematical Methods in Medicine, 2015: 259474, 2015.     
  29. Hirakawa A, Wages NA, Sato H, Matsui S. A comparative study of adaptive dose-finding designs for phase I oncology trials of combination therapies. Statistics in Medicine, 34: 3194-3213, 2015.     
  30. Hirakawa A, Yonemori K, Kuwatsuka Y, Kodaira M, Yamamoto H, Yunokawa M, Hamada A, Shimizu C, Tamura K, Gemma A, Fujiwara Y. A descriptive analysis of post-chemotherapy development of interstitial lung disease using spontaneous reporting data in Japan. Current Drug Safety, 9: 220-226, 2014.     
  31. Asano J, Hirakawa A, Hamada C. Assessing the prediction accuracy of cure in the Cox proportional hazards cure model: an application to breast cancer data. Pharmaceutical Statistics, 13:357-363, 2014.     
  32. Hirakawa A, Matsui S. Response to Letter to the Editor by Drs Wages et al. Statistics in Medicine, 33:2159-60 2014.     
  33. Asakawa T, Hirakawa A, Hamada C. Bayesian model averaging continual reassessment method for bivariate binary efficacy and toxicity outcomes in phase I oncology trials. Journal of Biopharmaceutical Statistics, 23:310-325, 2014.     
  34. Hirakawa A, Hamada C, Matsui S. A dose-finding approach based on shrunken predictive probability for combinations of two agents in phase I trials. Statistics in Medicine, 32:4515-4525,2013     
  35. Hirakawa A. An adaptive dose-finding approach for correlated bivariate binary and continuous outcomes in phase I oncology trials. Statistics in Medicine, 31:516-532, 2012. 

書籍

平川晃弘．(2023)．マスタープロトコルに基づく臨床試験．丹後 俊郎・松井 茂之（編）．臨床試験の事典．朝倉書店．
https://www.asakura.co.jp/detail.php?book_code=32264

平川晃弘，佐藤宏征．(2022). 臨床試験のデザインと統計解析．内田一郎・芹生卓（編集）.  製薬医学入門：くすりの価値最大化をめざして．メディカンル・サイエンス・インターナショナル
https://www.medsi.co.jp/products/detail/3863

Daimon T, Hirakawa A, Matsui S. (2019).Dose-Finding Designs for Early Phase Cancer Clinical Trials. Springer.
https://link.springer.com/book/10.1007/978-4-431-55585-8

Hirakawa A, Sato H, Daimon T, Matsui S. (2018). Modern Dose-Finding Designs for Cancer Phase I Trials: Drug Combinations and Molecularly Targeted Agents, Springer.
https://www.springer.com/us/book/9784431555728

平川晃弘，五所正彦（監訳）．(2018)．臨床試験のためのアダプティブデザイン．朝倉書店．
https://www.asakura.co.jp/books/isbn/978-4-254-12840-6/

Hirakawa A, Hiroyuki Sato. (2017). A comparative study of model-based dose-finding methods for two-agent combination trials. Frontiers of Biostatistical Methods and Applications in Clinical Oncology, Springer.
https://www.springer.com/gp/book/9789811001246

平川晃弘（監訳）．(2017)．臨床試験のためのデータモニタリング委員会：実践ハンドブック．スーザン・エレンバーグ，トーマス・フレミング，デビット・デメッツ．Data Monitoring Committees in Clinical Trials: A Practical Perspective．サイエンティスト社
https://scientist-press.com/2019/06/12/igaku-001/

Hirakawa A, Matsui S. (2014). Dose-finding for two-agent combination phase I trials. Developments in Statistical Evaluation of Clinical Trials, Springer.
https://link.springer.com/book/10.1007/978-3-642-55345-5

Daimon T, Hirakawa A, Matsui S. (2014). Phase I dose-finding designs and their applicability to targeted therapies. Design and Analysis of Clinical Trials for Predictive Medicine, CRC Press.
https://www.routledge.com/Design-and-Analysis-of-Clinical-Trials-for-Predictive-Medicine/Matsui-Buyse-Simon/p/book/9780367738433

 平川晃弘（共訳）．五所正彦（監訳）． (2014)．生存時間解析入門 [原著第2版]．Applied Survival Analysis, 2nd edition. 東京大学出版会
https://www.utp.or.jp/book/b306664.html

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