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-NowInstitute of Science Tokyo, 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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2023.08-2024.09Tokyo 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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2024.10-2024.12Institute of Science Tokyo, -, Graduate Schools, Public Health, Department of Clinical Biostatistics, Assistant Professor
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2025.01-NowInstitute of Science Tokyo, -, Graduate Schools, Public Health, Department of Clinical Biostatistics, Junior Associate Professor
Published Papers & Misc 【 display / non-display 】
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Yajima S, Yoshida S, Chen W, Fukushima H, Tanaka H, Sato H, Hirakawa A, Masuda H, Fujii Y.. Mixture cure model analysis of event-free survival in the NIAGARA Trial: Quantifying the cure fraction benefit of perioperative durvalumab in muscle-invasive bladder cancer. Urol Oncol. 2026.08; 44 (8): 120-126. ( PubMed, DOI )
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Hirose K, Yoshida S, Chen W, Yajima S, Sato H, Hirakawa A, Tanabe K, Fujiwara M, Fukushima H, Yasuda Y, Tanaka H, Masuda H, Fujii Y.. Bayesian reanalysis of the NIAGARA trial using reconstructed individual patient data: perioperative durvalumab in cisplatin-eligible muscle-invasive bladder cancer. Jpn J Clin Oncol. 2026.08; 56 (8): 1015-1021. ( PubMed, DOI )
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Fujiwara M, Yoshida S, Yajima S, Tanabe K, Chen W, Sato H, Hirakawa A, Fukushima H, Yasuda Y, Tanaka H, Yokoyama M, Fujii Y.. Delayed Progression-Free Survival Benefit of Belzutifan Versus Everolimus in LITESPARK-005: A Reconstructed Time-to-Event Reanalysis. Clin Genitourin Cancer. 2026.08; 24 (5): 102566. ( PubMed, DOI )
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Yajima S, Yoshida S, Chen W, Fukushima H, Tanaka H, Sato H, Hirakawa A, Masuda H, Fujii Y.. Exploratory Time-Dependent Patterns in Estimated Treatment Effect of Talazoparib Plus Enzalutamide in HRR Non-Deficient or Unknown Metastatic Castration-Resistant Prostate Cancer: A Post Hoc Analysis of the TALAPRO-2 Trial. Int J Urol. 2026.07; 33 (7): e70582. ( PubMed, DOI )
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Chen W, Yoshida S, Yajima S, Sato H, Hirakawa A, Fujii Y.. Quantifying benefit of adding docetaxel to androgen receptor-axis therapy in metastatic hormone-sensitive prostate cancer with Bayesian analysis. Int Urol Nephrol. 2026.07; 58 (7): 2609-2611. ( PubMed, DOI )
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Fujiwara M, Yoshida S, Yajima S, Sato H, Hirakawa A, Fukushima H, Arita Y, Tanaka H, Yokoyama M, Masuda H, Fujii Y.. Bayesian Analysis to Refine East Asian Subgroup Estimates in the CLEAR Trial (Lenvatinib Plus Pembrolizumab vs. Sunitinib) for Advanced Renal Cell Carcinoma Anticancer Res. 2026.07; 46 (7): 3889-3896. ( PubMed, DOI )
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Chen W, Yoshida S, Yajima S, Fukushima H, Sato H, Hirakawa A, Yamamoto T, Honda H, Matsuo T, Wada N, Masuda H, Fujii Y.. Quantitative Assessment of Additive Effects of Mirabegron and Solifenacin in Overactive Bladder: Re-analysis of SYNERGY Study. Urology. 2026.07; ( PubMed, DOI )
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Yajima S, Yoshida S, Chen W, Fukushima H, Waseda Y, Tanaka H, Sato H, Hirakawa A, Masuda H, Fujii Y.. Probabilistic Multicriteria Decision Analysis of Minimally Invasive Treatments for Benign Prostatic Obstruction: A Secondary Analysis of Network Meta-Analysis Data. Low Urin Tract Symptoms. 2026.07; 18 (4): e70083. ( PubMed, DOI )
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Yajima S, Yoshida S, Chen W, Fukushima H, Tanaka H, Sato H, Hirakawa A, Masuda H, Fujii Y.. Bayesian secondary reanalysis of published aggregate data on circulating tumor DNA for molecular residual disease detection across cancer types. Ann Clin Biochem. 2026.07; 45632261475618. ( PubMed, DOI )
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Yajima S, Yoshida S, Imasato N, Chen W, Sato H, Hirakawa A, Fukushima H, Tanaka H, Masuda H, Fujii Y.. Postoperative Management After Pathological Complete Response to Neoadjuvant Therapy for Muscle-Invasive Bladder Cancer: An Exploratory Reconstructed Individual Patient Data Analysis. Clin Genitourin Cancer. 2026.06; 24 (6): 102603. ( PubMed, DOI )
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Yasuda Y, Yoshida S, Yajima S, Sato H, Hirakawa A, Fujii Y.. Restricted mean survival time comparison of olaparib plus abiraterone versus talazoparib plus enzalutamide in first-line metastatic castration-resistant prostate cancer: indirect analyses of propel and talapro-2. Int Urol Nephrol. 2026.06; 58 (6): 2103-2105. ( PubMed, DOI )
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Yasuda Y, Yoshida S, Yajima S, Yamaguchi Y, Chen W, Tanaka H, Sato H, Hirakawa A, Suzuki K, Ishihara K, Yonese I, Tamiya T, Izumi K, Yamamoto T, Nakamura Y, Uehara S, Toide M, Araki S, Kawamura N, Asano T, Takazawa R, Numao N, Fujii Y.. Real-World Comparison of Triplet Versus Doublet Therapy in Japanese Patients With High-Volume Metastatic Hormone-Sensitive Prostate Cancer: A Propensity-Weighted Analysis From the YUSHIMA Registry and Exploratory Bayesian Evidence Synthesis. Prostate. 2026.06; 86 (8): 911-919. ( PubMed, DOI )
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Murakami R, Sato H, Hirakawa A.. Risk of Insomnia Disorder in Japanese Cancer Patients: A Matched Cohort Study Using Employer-Based Health Insurance Claims Data. Cancer Med. 2026.06; 15 (6): e71913. ( PubMed, DOI )
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Yajima S, Yoshida S, Fukuda S, Chen W, Sato H, Hirakawa A, Fukushima H, Matsuoka Y, Kageyama Y, Tanaka H, Inoue M, Numao N, Yonese J, Nakayama A, Saito K, Ito M, Koga F, Masuda H, Fujii Y.. Prognostic Value of Inflammatory Biomarkers as Continuous Variables in Metastatic Renal Cell Carcinoma: Linearity Assessment, Proportional Hazards Assumption Testing, and Time-Varying Effects. Int J Urol. 2026.06; 33 (6): e70536. ( PubMed, DOI )
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Chen W, Yoshida S, Yajima S, Fujiwara M, Sato H, Hirakawa A, Fukushima H, Yasuda Y, Tanaka H, Fujii Y.. Bayesian re-analysis of ERA223 and PEACE-3 temporal dynamics and bone protection in radium-223-treated metastatic castration-resistant prostate cancer. Jpn J Clin Oncol. 2026.06; ( PubMed, DOI )
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Yajima S, Yoshida S, Chen W, Sato H, Hirakawa A, Fukushima H, Nakamura Y, Tanaka H, Inoue M, Numao N, Yoshinaga A, Kawamura N, Yonese I, Izumi K, Yamamoto T, Uehara S, Suzuki K, Toide M, Takazawa R, Araki S, Masuda H, Fujii Y.. Real-world efficacy of enfortumab vedotin in Japanese patients with metastatic urothelial carcinoma stratified by EV-301 trial eligibility: a multicenter Bayesian restricted mean survival time analysis. Jpn J Clin Oncol. 2026.05; 56 (5): 636-645. ( PubMed, DOI )
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Hanazawa R, Sato H, Suzuki K, Hirakawa A.. Applying a statistical model-based AI method to identify prognostic factors for long-term cognitive decline in Alzheimer's disease: Evidence from pooled placebo data of four phase III trials. Int J Med Inform. 2026.05; 211 106337. ( PubMed, DOI )
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Chen W, Yoshida S, Hirakawa A, Sato H, Yajima S, Kobayashi M, Fujiwara M, Fukushima H, Arita Y, Waseda Y, Tanaka H, Masuda H, Fujii Y.. Clinical efficacy of apalutamide in Asian patients with metastatic castration-sensitive prostate cancer: Bayesian reanalysis of the TITAN trial. Jpn J Clin Oncol. 2026.04; 56 (4): 455-460. ( PubMed, DOI )
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Chen W, Yoshida S, Yajima S, Sato H, Hirakawa A, Tanabe K, Fukushima H, Yasuda Y, Tanaka H, Masuda H, Fujii Y.. Pharmacologic synergy versus independent action in androgen receptor-axis-targeted agent-docetaxel triplet therapy for metastatic hormone-sensitive prostate cancer: a copula-based analysis. Urol Oncol. 2026.04; 44 (4): 110990. ( PubMed, DOI )
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Yajima S, Yoshida S, Chen W, Fukushima H, Fukuda S, Tanaka H, Sato H, Hirakawa A, Masuda H, Fujii Y.. Probabilistic multi-criteria decision analysis comparing single-port and multiport robot-assisted radical prostatectomy and partial nephrectomy: A secondary analysis of systematic review data. J Robot Surg. 2026.04; 20 (1): ( PubMed, DOI )
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Tanabe K, Yoshida S, Fujiwara M, Chen W, Yajima S, Sato H, Hirakawa A, Fukushima H, Yasuda Y, Tanaka H, Masuda H, Fujii Y.. Reanalysis of LUNAR progression-free survival using reconstructed individual patient data: time-varying treatment effects. Int Urol Nephrol. 2026.04; ( PubMed, DOI )
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Yajima S, Yoshida S, Fukuda S, Chen W, Sato H, Hirakawa A, Fukushima H, Matsuoka Y, Kageyama Y, Tanaka H, Inoue M, Numao N, Yonese J, Nakayama A, Saito K, Ito M, Koga F, Masuda H, Fujii Y.. External validation of the Meet-URO score in Japanese metastatic renal cell carcinoma patients receiving first-line immune-combinations. Int Urol Nephrol. 2026.04; ( PubMed, DOI )
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Fukushima H, Yoshida S, Yajima S, Chen W, Sato H, Hirakawa A, Fujiwara M, Arita Y, Yasuda Y, Tanaka H, Masuda H, Fujii Y. Bayesian Methods for Subgroup Efficacy and Safety: Application to Japanese Patients in JAVELIN Renal 101. JCO Clin Cancer Inform. 2026.04; 10 (2): e2500307. ( PubMed, DOI )
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Matsumoto S, Yoshida S, Yajima S, Sato H, Hirakawa A, Fujiwara M, Fukushima H, Yasuda Y, Waseda Y, Tanaka H, Yokoyama M, Masuda H, Fujii Y.. A probabilistic multicriteria decision analysis of robot-assisted versus laparoscopic sacrocolpopexy: a secondary analysis of published meta-analytic data. J Robot Surg. 2026.03; 20 (1): ( PubMed, DOI )
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Tanabe K, Yoshida S, Chen W, Yajima S, Sato H, Hirakawa A, Fukushima H, Yasuda Y, Tanaka H, Masuda H, Fujii Y. Bayesian Multi-Criteria Decision Analysis of Net Clinical Benefit in ARASENS: Overall and Japanese Subgroup Results. Int J Urol. 2026.02; 33 (2): e70384. ( PubMed, DOI )
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Fukushima H, Yoshida S, Yajima S, Chen W, Sato H, Hirakawa A, Fujiwara M, Arita Y, Yasuda Y, Tanaka H, Morizane S, Yokoyama M, Masuda H, Takenaka A, Fujii Y.. A multi‑criteria decision analysis comparing robot‑assisted, laparoscopic, and open radical cystectomy using large-scale Japanese nationwide databases. J Robot Surg. 2026.02; 20 (1): 230. ( PubMed, DOI )
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Fukushima H, Yajima S, Sato H, Hirakawa A, Yoshida S, Fuji Y.. Bayesian Re-Interpretation of the CheckMate-9ER Final Analysis: Organ-Site and IMDC Risk-Stratified Probabilities of Benefit. Int J Urol. 2026.02; 33 (2): e70379. ( PubMed, DOI )
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Asano J, Sato H, Watanabe S, Hirakawa A.. Bayesian Power Prior in Platform Trials With Non-Concurrent Control for Binary Outcomes: Development and Comparative Evaluation. Stat Med. 2026.01; 45 (1-2): e70387. ( PubMed, DOI )
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Nankaku A, Kasai S, Shiomi A, Masuda T, Hazama H, Iwata N, Kato S, Yamauchi S, Sato H, Hirakawa A, Kagawa H, Tokunaga M, Kinugasa Y.. Comparing Prophylactic Administration of Sulbactam/Ampicillin Versus Cefmetazole for Prevention of Perineal Wound Infection Following Abdominoperineal Resection for Rectal Cancer: A Multicenter Randomized Controlled Trial. Ann Gastroenterol Surg. 2026.01; 10 (1): 15-24. ( PubMed, DOI )
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Yajima S, Yoshida S, Chen W, Sato H, Hirakawa A, Fujiwara M, Yokoyama M, Arita Y, Fukushima H, Yasuda Y, Tanaka H, Masuda H, Fujii Y.. Probabilistic multi-criteria decision analysis comparing robot-assisted and laparoscopic radical nephroureterectomy. J Robot Surg. 2026.01; 20 (1): 162. ( PubMed, DOI )
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Watanabe S, Shimizu Y, Sato H, Uemura Y, Hirakawa A.. Evolving Variants, Shifting Outcomes: Implications for Nonconcurrent Controls in Platform Trials for COVID-19. Pharm Stat. 2026; 25 (3): e70096. ( PubMed, DOI )
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Kaga M, Sasaki M, Masuda T, Sato H, Ueda T, Hirakawa A.. Exploring the association between happy hypoxia and Coronavirus disease 2019 in the triage phase. Future Sci OA. 2025.12; 11 (1): 2458413. ( PubMed, DOI )
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Goto K, Miyazaki S, Nakamura K, Nitta J, Murakami M, Hasegawa K, Inaba O, Kobori A, Yamauchi Y, Naito S, Mizuno S, Tada H, Sasaki Y, Sato H, Hirakawa A, Sasano T.. A randomized controlled trial of two pulsed field ablation systems for paroxysmal atrial fibrillation: the DUAL-PULSE trial rationale and design. J Interv Card Electrophysiol. 2025.12; 68 (9): 1801-1807. ( PubMed, DOI )
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Takahashi T, Sato H, Takahashi Y, Watanabe K, Banno T, Sakaki K, Arai Y, Takano Y, Eguchi Y, Taniguchi Y, Maki S, Aoki Y, Yoshii T, Yamada H, Kaito T, Hiraizumi Y, Yamagata M, Nakamura M, Hosogane N, Hirakawa A, Ohtori S, Hirai T.. Cost-effectiveness of intradiscal injection with condoliase versus microendoscopic discectomy for lumbar disc herniation: a retrospective multicenter study. Sci Rep. 2025.12; 15 (1): 43913. ( PubMed, DOI )
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Hashizume A, Hanazawa R, Yamada S, Ito D, Kishimoto Y, Komori S, Kawase T, Iida M, Kondo A, Mori Y, Obara K, Morita M, Yamamoto T, Sato H, Hirakawa A, Katsuno M.. Therapeutic impact of leuprorelin acetate on spinal and bulbar muscular atrophy: pre- and post-marketing observational study. J Neurol. 2025.11; 272 (12): 772. ( PubMed, DOI )
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Itakura T, Sasaki H, Hosoya T, Umezawa N, Saito T, Iwai H, Hasegawa H, Sato H, Hirakawa A, Imai K, Morio T, Kimura N, Yasuda S.. The role of TRECs/KRECs as immune indicators that reflect immunophenotypes and predict the risk of infection in systemic autoimmune diseases. Immunol Med. 2025.09; 48 (3): 233-244. ( PubMed, DOI )
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Yamada K, Toba M, Sato H, Egawa S, Morishita S, Matsukura Y, Hirai T, Hirakawa A, Kudo A, Fushimi K, Yoshii T.. Do Postoperative Outcomes of Surgical Treatment for Spinal Metastasis Differ by Institutional Function?: Analysis of a Nationwide Administrative Database in Japan. Clin Spine Surg. 2025.09; ( PubMed, DOI )
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Sato H, Hanazawa R, Suzuki K, Hashizume A, Hirakawa A.. Self-Organized Prediction-Classification- Superposition of Longitudinal Cognitive Decline in Alzheimer's Disease: An Application to Novel Clinical Research Methodology. IEEE J Biomed Health Inform. 2025.08; 29 (8): 5922-5935. ( PubMed, DOI )
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Hirai T, Takahashi T, Takahashi Y, Watanabe K, Banno T, Sakaki K, Arai Y, Takano Y, Eguchi Y, Taniguchi Y, Maki S, Aoki Y, Fujii S, Sakaeda K, Matsukura Y, Akazawa T, Minamide A, Nojiri H, Sakai K, Kato S, Tamai K, Suzuki H, Miyagi M, Sato H, Yoshii T, Yamada H, Kaito T, Hiraizumi Y, Yamagata M, Nakamura M, Hirakawa A, Hosogane N, Ohtori S.. Clinical and Economic Outcomes of Intradiscal Injection of Condoliase for a Treatment of Lumbar Disc Herniation with Severe Low Back Pain: A Multicenter Study. Spine Surg Relat Res. 2025.05; 9 (3): 368-374. ( PubMed, DOI )
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Shimizu Y, Hanazawa R, Sato H, Hirakawa A.. Operating characteristics of unequal allocation ratios in platform trials with the staggered addition of drugs using binary endpoints. Contemp Clin Trials Commun. 2025.04; 44 101450. ( PubMed, DOI )
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Kato M, Sato H, Naito Y, Yamamoto A, Kawanishi H, Nakano Y, Nishikimi T, Kobayashi M, Kondo A, Hirabayashi H, Katsuno S, Sakamoto F, Kimura T, Yamamoto S, Araki H, Tochigi K, Ito F, Hatsuse H, Sassa N, Hirakawa A, Akamatsu S, Tsuzuki T.. Prospective observational study on the relationships between genetic alterations and survival in Japanese patients with metastatic castration-sensitive prostate cancer: the impact of IDC-P. Int J Clin Oncol. 2025.04; 30 (4): 789-796. ( PubMed, DOI )
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Hanazawa R, Sato H, Hirakawa A; Alzheimer’s Disease Neuroimaging Initiative.. Mixture Disease Progression Model to Predict and Cluster the Long-Term Trajectory of Cognitive Decline in Alzheimer's Disease. Ther Innov Regul Sci. 2025.03; 59 (2): 264-277. ( PubMed, DOI )
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Hirakawa A, Asakawa T, Tokushige K, Ozaki R, Yoshida M, Okuma HS, Saito S, Shimizu Y, Kitabayashi R, Hanazawa R, Sato H, Uemura Y.. Planning and Implementing Master Protocol Trials in Japan: Key Considerations of the Japanese Guideline. Clin Pharmacol Ther. 2025.03; 117 (3): 627-632. ( PubMed, DOI )
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Nakatochi M, Yoshida K, Fujitani M, Ohashi Y, Kinoshita F, Kobayashi Y, Sato H, Takahashi Y, Murashita K, Hirakawa A.. Associations among smoking, sleep quality, and decline in Mini-Mental State Examination scores based on health check-up data in Japan: a case-control study. Nagoya J Med Sci. 2025.02; 87 (1): 105-121. ( PubMed, DOI )
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Hirai S, Fujita K, Fujii S, Takahashi S, Shigeta K, Karakama J, Enomoto Y, Sato Y, Yoshimura M, Hirota S, Mizoue T, Yoshino Y, Kawano Y, Yamamura T, Kohyama S, Hirohata M, Yoshimura S, Ishii Y, Yamauchi T, Taira N, Obata Y, Sakamoto M, Inoue M, Yamashina M, Tokunaga S, Higashi T, Sawada K, Mochida H, Ido K, Takeuchi M, Takigawa T, Takagi Y, Morimoto M, Nanto M, Miki K, Misaki K, Arimura K, Hanaoka Y, Hara M, Hara S, Yokoyama K, Ooyama J, Hanazawa R, Sato H, Hirakawa A, Ishiguro M, Nemoto S, Sumita K.. Correction: Study protocol of the ASTOP trial: A multicenter, randomized, double-blind, placebo-controlled trial of presurgical aspirin administration for the prevention of thromboembolic complications of coil embolization for ruptured aneurysms. PLoS One. 2025; 20 (8): e0329657. ( PubMed, DOI )
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Aoyama Y, Uchiyama C, Koike Y, Hayashi K, Tokuda I, Sato H, Hirakawa A, Yamamoto Y, Kobayashi W, Ihara K, Murashita K, Nakaji S.. Association between Salivary pH and Estimated Glomerular Filtration Rate Status in a Community-Dwelling Population: A Cross-Sectional Study. Nephron. 2025; 149 (9): 519-529. ( PubMed, DOI )
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Kitabayashi R, Takeda K, Sato H, Hirakawa A.. BOIN-MEM: A Two-Stage Design for Dose Optimization With Information Borrowing Across Dose Levels and Stages in Oncology Phase I/II Trials. Pharm Stat. 2025; 24 (6): e70045. ( PubMed, DOI )
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Katsuda H, Kobayashi M, Ito G, Kawamoto A, Krimura S, Sato H, Hirakawa A, Akahoshi K, Kudo A, Ohtsuka K, Okamoto R.. Evaluating endoscopic ultrasound-guided tissue acquisition for diagnosis of small pancreatic neuroendocrine neoplasms. Endosc Int Open. 2024.11; 12 (11): E1379-E1385. ( PubMed, DOI )
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Arai S, Hanaoka M, Yamauchi S, Baba H, Hanazawa R, Sato H, Hirakawa A, Tokunaga M, Kinugasa Y.. Modified oral antibiotics and mechanical bowel preparation (OAMBP) versus conventional OAMBP for sigmoid colon and rectal surgery: A multicenter randomized non-inferiority trial. Ann Gastroenterol Surg. 2024.11; 8 (6): 1036-1045. ( PubMed, DOI )
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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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Hirai S, Fujita K, Fujii S, Takahashi S, Shigeta K, Karakama J, Enomoto Y, Sato Y, Yoshimura M, Hirota S, Mizoue T, Yoshino Y, Kawano Y, Yamamura T, Kohyama S, Hirohata M, Yoshimura S, Ishii Y, Yamauchi T, Taira N, Obata Y, Sakamoto M, Inoue M, Yamashina M, Tokunaga S, Higashi T, Sawada K, Mochida H, Ido K, Takeuchi M, Takigawa T, Takagi Y, Morimoto M, Nanto M, Miki K, Misaki K, Arimura K, Hanaoka Y, Hara M, Hara S, Yokoyama K, Ooyama J, Hanazawa R, Sato H, Hirakawa A, Ishiguro M, Nemoto S, Sumita K.. Study protocol of the ASTOP trial: A multicenter, randomized, double-blind, placebo-controlled trial of presurgical aspirin administration for the prevention of thromboembolic complications of coil embolization for ruptured aneurysms. PLoS One. 2024; 19 (9): e0310906. ( 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