Statistical Methodology Research Publications (Selected Papers)
Hamasaki T, Hung HMJ, Hsiao CF, Evans SR. On selecting the critical boundary functions in group-sequential trials with two time-to-event outcomes. Contemporary Clinical Trials 2021;101:106244. Abstract
Yin X, Hamasaki T, Evans SR. Sequential Multiple Assignment Randomized Trials for COMparing Personalized Antibiotic StrategieS (SMART COMPASS): Design considerations. Statistics in Biopharmaceutical Research 2021; 13:181-191. Abstract
Follmann D, Fay MP, Hamasaki T, Evans SR. Analysis of ordered composite endpoints. Statistics in Medicine 2020; 39:602-615. Abstract
Asakura K, Evans SR, Hamasaki T. Interim monitoring for futility in clinical trials with two co-primary endpoints using prediction. Statistics in Biopharmaceutical Research 2020; 12:164-175. Abstract
Sugimoto T, Hamasaki T, Evans SR, Halabi S. Group-sequential logrank methods for trial designs using bivariate non-competing event time outcomes. Lifetime Data Analysis 2020; 26:266–291. Abstract
Evans SR, Follmann D, Liu Y, Holland T, Doernberg SB, Rouphael N, Hamasaki T, Jiang Y, Lok J, Harris A, Fowler V, van Duin D, Patterson D, Chambers H. Sequential multiple assignment randomized trials for comparing personalized antibiotic strategies (SMART-COMPASS). Clinical Infectious Disease 2019; 68:1961-1967. Abstract
Hamasaki T, Evans SR, Asakura K. Design, data monitoring and analysis of clinical trials with co-primary endpoints: A review. Journal of Biopharmaceutical Statistics 2018; 28:28-51. Abstract
Huang WS, Hung HN, Hamasaki T, Hsiao CF. Sample size determination for a specific region in multiregional clinical trials with multiple co-primary endpoints. PLoS ONE 2017; 12:e01804052017. Abstract
Sugimoto T, Hamasaki T, Evans SR, Sozu T. Sizing clinical trials when comparing bivariate time-to-event outcomes. Statistics in Medicine 2017; 36:1363-1382. Abstract
Asakura K, Hamasaki T, Evans SR. Interim evaluation of efficacy or futility in group-sequential trials with multiple co-primary endpoints. Biometrical Journal 2017; 59:703-731. Abstract
Ochiai T, Hamasaki T, Evans SR, Asakura K, Ohno Y. Group-sequential three-arm noninferiority clinical trial designs. Journal of Biopharmaceutical Statistics 2017; 27:1-24. Abstract
Sozu T, Sugimoto T, Hamasaki T.Reducing unnecessary measurements in clinical trials with multiple primary endpoints. Journal of Biopharmaceutical Statistics 2016; 26:631-643. Abstract
Ando Y, Hamasaki T, Asakura K, Evans SR, Sugimoto T, Sozu T, Ohno, Y. Sample size considerations in clinical trials when comparing two interventions using multiple co-primary binary relative risk contrasts. Statistics in Biopharmaceutical Research 2015; 7:81-94. Abstract
Hamasaki T, Asakura K, Evans SR, Sugimoto T, Sozu T. Group sequential strategies for clinical trials with multiple co-primary endpoints.Statistics in Biopharmaceutical Research 2015; 7:36-54. Abstract
Asakura K, Hamasaki T, Sugimoto T, Hayashi K, Evans SR, Sozu T. Sample size determination in group-sequential clinical trials with two co-primary endpoints. Statistics in Medicine 2014; 33:2897-2913. Abstract
Sugitani T, Hamasaki T, Hamada C. Partition testing in confirmatory adaptive designs with structured objectives. Biometrical Journal 2013; 55:341-59. Abstract
Hamasaki T, Sugimoto T, Evans SR, Sozu T.Sample size determination for clinical trials with co-primary outcomes. Exponential event-times. Pharmaceutical Statistics 2013; 12:28-34. Abstract
Sugimoto T, Sozu T, Hamasaki T, Evans SR.A logrank test-based method for sizing clinical trials with two co-primary time-to-events endpoints. Biostatistics 2013; 14:409-421. Abstract
Sozu T, Sugimoto T, Hamasaki T. Sample size determination in clinical trials with multiple co-primary endpoints including mixed continuous and binary variables. Biometrical Journal 2012; 54:716-729. Abstract
Sugimoto T, Sozu T, Hamasaki T. A convenient formula for sample size calculations in clinical trials with multiple co-primary continuous endpoints. Pharmaceutical Statistics 2012; 11:118-128. Abstract
Sozu T, Sugimoto T, Hamasaki T. Sample size determination in superiority clinical trials with multiple co-primary correlated endpoints. Journal of Biopharmaceutical Statistics 2011; 21:650-668. Absract
Sozu T, Sugimoto T, Hamasaki T. Sample size determination in clinical trials with multiple co-primary binary endpoints. Statistics in Medicine 2010; 29:2169-2179. Abstract
Ando Y, Hamasaki T. Practical issues and lessons learned from multi-regional clinical trials via case examples: A Japanese perspective. Pharmaceutical Statistics 2010; 9:190-200. Abstract
Arano I, Sugimoto T, Hamasaki T, Ohno Y. Practical application of cure mixture model to long-term censored survivor data from a withdrawal clinical trial of patients with major depressive disorder. BMC Medical Research Methodology 2010; 10:33. Abstract
Hamasaki T, Kim SY. Box and Cox power-transformation to confined and censored nonnormal responses in regression. Computational Statistics & Data Analysis 2007; 51:3788-3799. Abstract
Sugimoto T, Hamasaki T. Properties of estimators for baseline hazard functions in a semiparametric cure model. Annals of the Institute of Statistical Mathematics 2006; 58:647-674. Abstract
Goto M, Hamasaki T. Practical issues and observations on the use of foreign clinical data in the drug development. Journal of Biopharmaceutical Statistics 2002; 12:369-384. Abstract
Hamasaki T, Isomura T, Baba M, Goto M. Statistical approach to detecting dose-response relationships. Drug Information Journal 2000; 34:579-590. Abstract
Clinical Trials, and Observational Studies (Selected Papers)
Koga M, Yamamoto H, Inoue M, Asakura K, Aoki J, Hamasaki T, Kanzawa T, Kondo R, Ohtaki M, Itabashi R, Kamiyama K, Iwama T, Nakase T, Yakushiji Y, Igarashi S, Nagakane Y, Takizawa S, Okada Y, Doijiri R, Tsujino A, Ito Y, Ohnishi H, Inoue T, Akagi Y, Hasegawa Y, Shiokawa Y, Sakai N, Osaki M, Uesaka Y, Yoshimura S, Urabe T, Ueda T, Ihara M, Kitazono T, Sasaki M, Oita A, Yoshimura S, Fukuda-Doi M, Miwa K, Kimura K, Minematsu K, Toyoda K.Thrombolysis with alteplase at 0.6 mg/kg for stroke with unknown time of onset: a randomized controlled trial. Stroke 2020; 51:1530–1538.
Miyoshi T, Maeno Y, Hamasaki T, Inamura N, Yasukochi S, Kawataki M, Horigome H, Yoda H, Taketazu M, Nii M, Hagiwara A, Kato H, Shimizu W, Shiraishi I, Sakaguchi H, Ueda K, Katsuragi S, Yamamoto H, Sago H, Ikeda T, on behalf of the Japan Fetal Arrhythmia Group. Antenatal antiarrhythmic treatment for fetal tachyarrhythmias: a prospective multicentre trial. Journal of the American College of Cardiology 2019; 74:874-885 JACC Editor-in-Chief’s Top 100 papers in 2019
Kinoshita T, Yamakawa K, Matsuda H, Yoshikawa Y, Wada D, Hamasaki T, Ono K, Nakamori Y, Fujimi S. The survival benefit of a novel trauma workflow that includes immediate whole-body computed tomography, surgery, and interventional radiology, all in one trauma resuscitation room: A retrospective historical control study. Annals of Surgery 2019; 269:370-376.
Asakura M, Kim J, Asanuma H, Nakama Y, Tsukahara K, Higashino Y, Ishikawa T, Koba S, Tsujimoto M, Himeno H, Maruyama Y, Ookusa T, Yoda S, Suzuki H, Okubo S, Shimizu M, Hashimoto Y, Satake K, Fujino S, Uzui H, Nagai Y, Kohno T, Mizuno S, Nakahama M, Kanaya H, Murohara T, Fukui K, Takase H, Ohte N, Shiono T, Fukunami M, Endo T, Sawada R, Fujii K Takeuchi M, Ikeda S, Mizuno K, Uematsu M, Matsubara T, Yano S, Takahashi J, Ueda K, Kinoshita Y, Tamita K, Hayashi H, Hamasaki T, Kitakaze M, and PPAR investigators. Cardiovascular outcomes in patients with previous myocardial infarction and mild diabetes mellitus following treatment with pioglitazone: Reports of a randomised trial from the Japan working group for the assessment whether pioglitazone protects DM patients against re-infarction (PPAR Study). EClinicalMedicine 2018; 4:10-24.
Nakamura M, Iijima R, Ako J, Shinke T, Okada H, Ito Y, Ando K, Anzai H, Tanaka H, Ueda Y, Takiuchi S, Nishida Y, Ohira H, Kawaguchi K, Kadotani M, Niinuma H, Omiya K, Morita T, Zen K, Yasaka Y, Inoue K, Ishiwata S, Ochiai M, Hamasaki T, Yokoi H on behalf of the NIPPON investigators. Dual antiplatelet therapy for 6 versus 18 months after biodegradable polymer drug eluting stent implantation. Journal of the American College of Cardiology: Cardiovascular Interventions 2017; 10:1189-1198.
Iida O, Nakamura M, Yamauchi Y, Fukunaga M, Yokoi Y, Yokoi H, Soga Y, Zen K, Suematsu N, Inoue N, Suzuki K, Hirano K, Shintani Y, Miyashita Y, Urasawa K , Kitano I, Tsuchiya T, Kawamoto K, Yamaoka T, Uesugi M, Shinke T, Oba Y, Ohura N, Uematsu M, Takahara M, Hamasaki T, Nanto S. 3-year outcomes of the OLIVE Registry, a prospective multi-center study of patients with critical limb ischemia: A prospective, multi-center, three-year follow-up study on endovascular treatment for intra-inguinal vessel in patients with critical limb ischemia Journal of the American College of Cardiology: Cardiovascular Interventions 2015; 8:1493-1502
Wataya-Kaneda M, Tanaka M, Yang L, Yang F, Tsuruta D, Nakamura A, Matsumoto S, Hamasaki T, Tanemura A, Katayama I. Clinical and histologic analysis of the efficacy of topical rapamycin therapy against hypomelanotic macules in tuberous sclerosis complex. Journal of the American Medical Association: Dermatology 2015; 151:722-730.
Yamakawa K, Aihara M, Ogura H, Yuhara H, Hamasaki T, Shimazu T. Recombinant human soluble thrombomodulin in severe sepsis: a systematic review and meta-analysis. Journal of Thrombosis and Haemostasis 2015; 13:508-519.
Mabuchi S, Matsumoto Y, Kawano M, Minami K, Sasano T, Takahashi R, Kuroda H, Hisamatsu T, Kakigano A, Hayashi M, Sawada K, Seo Y, Hamasaki T, Morii E, Kurachi H, Matsuura N, Kimura T. Uterine cervical cancer displaying tumor-related leukocytosis: A distinct clinical entity with radioresistant feature.The Journal of the National Cancer Institute 2014; 106:dju147
Oze T, Hiramatsu N, Yakushijin T, Miyazaki M, Yamada A, Oshita M, Hagiwara H, Mita E, Ito T, Fukui H, Inui Y, Hijioka T, Inada M, Katayama K, Tamura S, Yoshihara H, Inoue A, Imai Y, Hayashi E, Kato M, Miyagi T, Yoshida Y, Tatsumi T, Kasahara A, Hamasaki T, Hayashi N, Takehara T. Significance of post-treatment alpha-fetoprotein levels for hepatocellular carcinoma incidence after interferon therapy. Clinical Gastroenterology and Hepatology 2014; 12:1186-1195.
Matsumoto S, Sakata Y, Nakatani D, Suna S, Usami M, Hara M, Kitamura T, Hamasaki T, Nanto S, Kawahara Y, Komuro I. Circulating p53-responsive microRNAs are predictive Indicators of Heart Failure after acute myocardial infarction. Circulation Research 2013; 113:322-326.
Iida O, Yokoi H, Soga Y, Inoue N, Suzuki K, Yokoi Y, Kawasaki D, Zen K, Urasawa K, Shintani Y, Miyamoto A, Hirano K, Miyashita Y, Tsuchiya T, Shinozaki N, Nakamura M, Isshiki T, Hamasaki T, Nanto S. Cilostazol reduces angiographic restenosis after endovascular therapy for femoropopliteal lesions in the sufficient treatment of peripheral intervention by cilostazol (STOP-IC) study. Circulation 2013; 127:2307-2315.
Iida O, Nakamura M, Yamauchi Y, Miyamoto A, Kawasaki D, Yokoi Y, Yokoi Y, Soga Y, Zen K, Hirano K, Suematsu N, Inoue N, Suzuki K, Shintani Y, Miyashita Y, Urasawa K, Kitano I, Yamaoka T, Murakami T, Uesugi M, Tsuchiya T, Shinke T, Oba Y, Ohura N, Hamasaki T, Nanto S, on behalf of the OLIVE investigators. Endovascular treatment for infrainguinal vessels in patients with critical limb ischemia. OLIVE registry, a prospective, multicenter study in Japan with 12-month Follow-up. Circulation: Cardiovascular Interventions 2013; 6:68-76.
Yamakawa K, Tasaki O, Fukuyama M, Kitayama J, Matsuda H, Nakamori Y, Fujimi S, Ogura H. Kuwagata Y, Hamasaki T, Shimazu T. Assessment of risk factors related to healthcare-associated methicillin-resistant Staphylococcus aureus infection at patient admission to an intensive care unit in Japan. BMC Infectious Diseases 2011; 11:303.
Matsushima A, Tasaki O, Tomono K, Ogura H, Kuwagata Y, Sugimoto H, Hamasaki T. Preemptive contact precautions for intubated patients reduced nosocomial transmission and infection by MRSA in an intensive care unit. Journal of Hospital Infection 2011; 78:97-101.
Yamakawa K, S Fujimi, T Mohri, H Matsuda, Y Nakamori, T Hirose, Tasaki O, Ogura H, Kuwagata Y, Hamasaki T, Shimazu S. Treatment effects of recombinant human soluble thrombomodulin in patients with severe sepsis: a historical control study. Critical Care 2011; 15:R123.
Shimizu K, Ogura H, Hamasaki T, Goto M, Tasaki O, Asahara T, Nomoto K, Morotomi M, Matsushima A, Kuwagata Y, Sugimoto H. Altered gut flora are associated with septic complications and death in critically ill patients with systemic inflammatory response syndrome. Digestive Diseases and Sciences 2011; 56:1171-1177.
Ikuno Y, Jo Y, Hamasaki T, Tano Y. Ocular risk factors for choroidal neovascularization in pathological myopia. Investigative Ophthalmology & Visual Science 2010; 51:3721-3725.
Yokoe M, Okuno R, Hamasaki T, Kurachi Y, Akasawa K, Sakoda S. Opening velocity, a novel parameter, for finger tapping test in patients with Parkinson's disease. Parkinsonism and Related Disorders 2009; 15:440-444.
Kitakaze M, Asakura M, Kim J, Shintani Y, Asanuma H, Hamasaki T, Seguchi O, Myoishi M, Minamino T, Ohara T, Nagai Y, Nanto S, Watanabe K, Fukuzawa S, Hirayama A, Nakamura N, Kimura K, Fujii K, Ishihara M, Saito Y, J-Wind Study Group. Human atrial natriuretic peptide and nicorandil as adjuncts to reperfusion treatment for acute myocardial infarction (J-WIND): Two randomised trials.The Lancet 2007; 370:1483-1493.
Sato T, Nakanishi T, Yamamoto Y, Andersen MP, Ogawa Y, Fukada K, Zhou Z, Aoike F, Sugai F, Nagano S, Hirata S, Ogawa M, Nakano R, Ohi T, Kato T, Nakagawa M, Hamasaki T, Shimizu A, Sakoda S. Rapid disease progression correlates with instability of mutant SOD1 in familial ALS. Neurology 2005; 65:1954-1957.
Sugai T, Yamamoto Y, Miyaguchi K, Zhou Z, Sumi H, Hamasaki T, Goto M, Sakoda S. Benefit of valproic acid in suppressing disease progression of ALS model mice. European Journal of Neuroscience 2004; 20:3178-3183.
Study Reporting, Education and Training, and Other Publications (Selected Papers)
Kaur A, Franco C, McMahan C, Mark M, Schmidt AM, Hamasaki T. Statisticians tell of COVID-19 effects around the world. AMSTAT NEWS 2021; 531(September 2021):42-44 Abstract
Hamasaki T, Bretz F, LaVange LM, Müller P, Pennello, Pinheiro JC. Roles of hypothesis testing, p-values and decision making in biopharmaceutical research. Statistics in Biopharmaceutical Research 2021; 13:1-5 Abstract
Hamasaki T, Bretz F, Cooner F, LaVange LM, Posch M. Statistical challenges in the conduct and management of ongoing clinical trials during the COVID-19 pandemic. Statistics in Biopharmaceutical Research 2020; 12:397-398 Abstract
Yin X, Hamasaki T, Follmann D, Evans SR. OutSMARTing Superbugs. CHANCE 2020; 33(3):22-30 Abstract
Dimairo M, Coates E, Pallmann O, Todd S, Julious SA, Jaki T, Wason J, Mander AP, Weir CJ, König F, Walton MK, Biggs K, Nicholl J, Hamasaki T, Proschan MA, Scott JA, Ando Y, Hind D, Altman DG. The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. BMJ 2020;369:m115 Abstract, Trials 2020; 21:528 Abstract,
Dimairo M, Coates E, Pallmann O, Todd S, Julious SA, Jaki T, Wason J, Mander AP, Weir CJ, König F, Walton MK, Biggs K, Nicholl J, Hamasaki T, Proschan MA, Scott JA, Ando Y, Hind D, Altman DG. Development of a consensus-driven CONSORT Extension for randomised trials using an adaptive design. BMC Medicine 2018; 16:210. Abstract
Book Chapters, Textbooks (Selected Publications)
Hamasaki T, Wu YJ, Hsiao CF. Multiple endpoints in multiregional clinical trials, Chapter 17, In Simultaneous Global New Drug Development; Multi-Regional Clinical Trials after ICH E17, eds by: Gang Li et al. London, 2021, CRC Press.
Sakamaki K, Sozu T, Hamasaki T. Multiple Comparison Procedures (Taju Hikaku). Tokyo: Asakura Shotan, 2019. (in Japanese)
Hamasaki T, Asakura K, Ochiai T, Evans SR. Group-Sequential Clinical Trials with Multiple Co-Objectives. Cham/Heidelberg/New York: Springer, 2016.
Sozu T, Sugimoto T, Hamasaki T, Evans SR. Sample Size Determination in Clinical Trials with Multiple Endpoints. Cham/Heidelberg/New York: Springer, 2015.
Hamasaki T. Statistical Essene of Clinical Trials (Rinshousiken no Toukeiteki Essene). Osaka: Osaka University Press, 2010. (in Japanese)
Interviews
Interview of Toshi Hamasaki by BIOP Report. ASA Biopharmaceutical Resport 2020; 27(2):20-22.
Episode 60: Toshimitsu Hamasaki. ASA Biopharm's Pocast, December 31, 2018.
Complete list avaiable in Google Scholar
Complete list available in PubMed