Graduate School 【 display / non-display 】
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Tokyo University of Science, Graduate School, Division of Engineering, Doctor's Course, Completed
Campus Career 【 display / non-display 】
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2020.04-2021.09Tokyo Medical and Dental University, (Old Organization)Medical Hospital, Central Clinical Facilities, Clinical Research Center, Assistant Professor
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2020.11-NowTokyo Medical and Dental University, Graduate School of Medical and Dental Sciences, Medical and Dental Sciences, Division of Public Health, Department of Clinical Biostatistics, Assistant Professor
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2021.10-2022.07Tokyo Medical and Dental University, Tokyo Medical and Dental University, Division of Clinical Management, Clinical Research Center, Assistant Professor
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2022.08-2023.07Tokyo Medical and Dental University, Tokyo Medical and Dental University, Division of Clinical Management, Clinical Research Center, Assistant Professor
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2023.08-NowTokyo Medical and Dental University, Graduate School of Medical and Dental Sciences, Medical and Dental Sciences, Division of Public Health, Department of Clinical Biostatistics, Assistant Professor
Published Papers & Misc 【 display / non-display 】
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Tanaka H, Fukawa Y, Yamamoto K, Tanimoto K, Takemoto A, Mori T, Hasumi H, Kinoshita M, Kanazawa T, Furukawa A, Kimura K, Sato H, Hirakawa A, Fukuda S, Waseda Y, Yoshida S, Campbell SC, Fujii Y. Prognostic impact and genomic backgrounds of renal parenchymal infiltration or micronodular spread in non-metastatic clear cell renal cell carcinoma. Mod Pathol. 2024.08; 100590. ( PubMed, DOI )
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12. Ito S, Kinugasa Y, Yamauchi S, Sato H, Hirakawa A, Ishihara S, Shiomi A, Kanemitsu Y, Suto T, Takahashi H, Itabashi M, Shiozawa M, Hiyoshi M, Kobatake T, Komori K, Egi H, Ozawa H, Yamaguchi T, Inada R, Ito M, Hirano Y, Furutani A, Tanabe Y, Ueno H, Ohue M, Hida K, Kawai K, Sunami E, Ishida H, Uehara K, Watanabe J, Hotchi M, Ishibe A, Takii Y, Hiro J, Numata M, Takemasa I, Kato T, Kakeji Y, Hirata A, Ajioka Y. Long-term Outcome After Surgical Resection of Paraaortic Lymph Node Metastasis of Colorectal Cancer: A Multicenter Retrospective Study. Dis Colon Rectum. 2024.07; ( PubMed, DOI )
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1. Sasaki M, Sato H, Uemura Y, Mikami A, Ichihara N, Fujitani S, Kondo M, Doi Y, Morino E, Tokita D, Ohmagari N, Sugiura W, Hirakawa A. How Much More Efficient Are Adaptive Platform Trials Than Multiple Stand-Alone Trials? A Comprehensive Simulation Study for Streamlining Drug Development During a Pandemic. Clin Pharmacol Ther. 2024.06; 115 (6): 1372-1382. ( PubMed, DOI )
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Sadachi R, Sato H, Fujiwara T, Hirakawa A.. Enhancement of Bayesian optimal interval design by accounting for overdose and underdose errors trade-offs. J Biopharm Stat. 2023.11; 1-20. ( PubMed, DOI )
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Fumie Kinoshita, Kei Yoshida, Masaya Fujitani, Yuta Imai, Yumiko Kobayashi, Tomoya Ito, Yuto Okumura, Hiroyuki Sato, Tatsuya Mikami, Songee Jung, Akihiro Hirakawa, Masahiro Nakatochi. Lifestyle parameters of Japanese agricultural and non-agricultural workers aged 60 years or older and less than 60 years: A cross-sectional observational study. PLoS One. 2023.10; 18 (10): e0290662. ( PubMed, DOI )
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Mizusawa J, Sato H, Rubinstein LV, Fujiwara T, Yonemori K*, Hirakawa A*. Racial differences in longitudinal toxicities of anticancer agents in early phase cancer clinical trials. Cancer Med. 2023.07; ( PubMed, DOI )
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Unuma K, Sato H, Wen S, Makino Y, Hirakawa A, Uemura K. The proportion of false-positives in positive Seratec® prostate-specific antigen SemiQuant test results in postmortem screening for seminal fluid. Legal medicine (Tokyo, Japan). 2023.05; 62 102243. ( PubMed, DOI )
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Hosoya T, Oba S, Komiya Y, Kawata D, Kamiya M, Iwai H, Miyamoto S, Kataoka M, Tobiume M, Kanno T, Ainai A, Sato H, Hirakawa A, Mitsui Y, Satoh T, Wakabayashi K, Yamada T, Otomo Y, Miyazaki Y, Hasegawa H, Suzuki T, Yasuda S. Apple-shaped obesity: A risky soil for cytokine-accelerated severity in COVID-19. Proceedings of the National Academy of Sciences of the United States of America. 2023.05; 120 (22): e2300155120. ( PubMed, DOI )
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Asano J, Sato H, Hirakawa A. Practical basket design for binary outcomes with control of family-wise error rate. BMC medical research methodology. 2023.02; 23 (1): 52.
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Takenaka K, Kitazume Y, Kawamoto A, Fujii T, Udagawa Y, Wanatabe R, Shimizu H, Hibiya S, Nagahori M, Ohtsuka K, Sato H, Hirakawa A, Watanabe M, Okamoto R. Serum Leucine-Rich α2 Glycoprotein: A Novel Biomarker for Transmural Inflammation in Crohn's Disease. The American journal of gastroenterology. 2022.12;
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Takahashi Y, Yamamoto T, Oyama J, Sugihara G, Shirai Y, Tao S, Takigawa M, Sato H, Sasaki M, Hirakawa A, Takahashi H, Goya M, Sasano T. Increase in Cerebral Blood Flow After Catheter Ablation of Atrial Fibrillation. JACC. Clinical electrophysiology. 2022.11; 8 (11): 1369-1377.
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Inagaki T, Hashizume A, Hijikata Y, Yamada S, Ito D, Kishimoto Y, Torii R, Sato H, Hirakawa A, Katsuno M. Development of a functional composite for the evaluation of spinal and bulbar muscular atrophy. Scientific reports. 2022.10; 12 (1): 17443.
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Murata K, Takahashi Y, Inaba O, Nitta J, Kobori A, Sakamoto Y, Nagata Y, Tanimoto K, Matsuo S, Yamane T, Morita N, Satomi K, Sato H, Hanazawa R, Hirakawa A, Goya M, Sasano T. Efficacy of left atrial posterior wall isolation guided by lesion size prediction module for non-paroxysmal atrial fibrillation. EP Europace. 2022.07; ( PubMed, DOI )
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Nakayama K, Shachar S, Finn EH, Sato H, Hirakawa A, Misteli T. Large-scale mapping of positional changes of hypoxia-responsive genes upon activation. Molecular biology of the cell. 2022.07; 33 (8): ar72.
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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. 2022.06; 41 (21): 4200-4214.
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Takino K, Kameshima M, Asai C, Kawamura I, Tomita S, Sato H, Hirakawa A, Yamada S. Neuromuscular electrical stimulation after cardiovascular surgery mitigates muscle weakness in older individuals with diabetes. Annals of physical and rehabilitation medicine. 2022.03; 101659.
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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. 2022.01; ( PubMed, DOI )
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Takahashi Y, Nitta J, Kobori A, Sakamoto Y, Nagata Y, Tanimoto K, Matsuo S, Yamane T, Morita N, Satomi K, Inaba O, Murata K, Sasaki Y, Yoshimoto D, Kaneko M, Tanimoto Y, Isogai R, Yamashita S, Sato H, Hanazawa R, Hirakawa A, Goya M, Sasano T. Alcohol Consumption Reduction and Clinical Outcomes of Catheter Ablation for Atrial Fibrillation. Circulation: Arrhythmia and Electrophysiollogy. 2021.05; 14 (6): e009770. ( PubMed, DOI )
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Kato M, Hirakawa A, Sato H, Hanazawa R, Naito Y, Tochigi K, Sano T, Ishida S, Funahashi Y, Fujita T, Matsukawa Y, Hattori R, Tsuzuki T. Grade group 2 (10% ≥ GP4) patients have very similar malignant potential with grade group 1 patients, given the risk of intraductal carcinoma of the prostate. International journal of clinical oncology. 2021.01; ( PubMed, DOI )
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Ikenouchi T, Inaba O, Takamiya T, Inamura Y, Sato A, Matsumura Y, Sato H, Hirakawa A, Takahashi Y, Goya M, Sasano T, Nitta J. The impact of left atrium size on selection of the pulmonary vein isolation method for atrial fibrillation: Cryoballoon or radiofrequency catheter ablation. American heart journal. 2021.01; 231 82-92. ( PubMed, DOI )
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Hirakawa A, Asano J, Sato H, Teramukai S. Master protocol trials in oncology: Review and new trial designs. Contemporary Clinical Trial Communication. 2018.12; 12 1-8. ( PubMed, DOI )
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Hirakawa A, Sato H, Gosho M. Effect of design specifications in dose-finding trials for combination therapies in oncology. Pharmaceutical Statistics. 2016.11; 15 (6): 531-540. ( PubMed, DOI )
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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. 2016.10; 35 (23): 4093-4109. ( PubMed, DOI )
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Hirakawa A, Sato H. Authors' Reply. Statistics in Medicine. 2016.02; 35 (3): 479-480. ( PubMed, DOI )
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Nagai S, Urata M, Sato H, Mikami M, Kuga W, Yanagihara R, Miyamoto D, Suzuki Y, Shikano M. Evolving Japanese regulations on companion diagnostics. Nature Biotechnology. 2016.02; 34 (2): 141-144. ( PubMed, DOI )
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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. 2015.10; 34 (24): 3194-3213. ( PubMed, DOI )
Books etc 【 display / non-display 】
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Sato H, Yamaguchi T, Ando Y, Nonaka T. Oncology Clinical Trials Successful Design, Conduct, and Analysis, Second Edition. Demos Medical Pub, 2018 The Evolution of the Drug Evaluation Process in Japan (ISBN : 978-0-8261-6872-6)
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Hirakawa A, Sato H, Daimon T, Matsui S. Modern Dose-Finding Designs for Cancer Phase I Trials: Drug Combinations and Molecularly Targeted. Springer, 2018
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Hirakawa A, Sato H. Frontiers of Biostatistical Methods and Applications in Clinical Oncology. Springer, 2017
Conference Activities & Talks 【 display / non-display 】
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Sato H, Sasaki M, Hirakawa A. Model calibration approaches for model uncertainty of dose-efficacy relationship in phase I trials for monotherapy of molecularly targeted agents.. 2022 WNAR Annual Meeting 2022.06.13
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Sato H, Asano J, Ando Y. Consideration of the estimation method for regional treatment effects in multi-regional clinical trials―regulatory perspectives-. International Symposium on Biopharmaceutical Statistics 2019.08
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Sato H, Hirakawa A, Hamada C. An adaptive dose-finding method using a change-point model for molecularly targeted agents in phase I trials. East Asia Regional Biometric Conference 2015 2015.12
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Sato H. Statistical issues in evaluating MRCT – Experiences in Japan. ISBS/DIA Joint Statistical Conference 2015 2015.06
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Sato H. Regulatory Japanese experience on adaptive clinical trial designs. Austria-Japan Joint Statistics Workshop 2015.03
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Sato H, Hirakawa A, Hamada C. Dose-finding approach based on efficacy and toxicity outcomes in phase I oncology trials for Molecularly Targeted Agents. Eastern North American Region 2015 Spring meeting 2015.03