Nagoya University Graduate School of Medicine
Education: Bachelor of Engineering, Dept. of Transportation Engineering, Tokyo Univ. of Sci.,
Master of Engineering, Dept. of Civil Engineering, Tokyo Univ. of Sci., 1993
Degree: Doctor of Engineering, Tokyo Univ. of Sci., 1999, Title of the Thesis: Design and
analysis of randomized clinical trials with recurrent events.
Employment: 1993.4-1995.3, Biostatistician, Rhone-Poulenc Rorer, Inc.
1998.4-2001.3, Research Associate, Department of Health Sciences, Oita University
2001.4-2002.4, Assistant Professor, Department of Health Sciences, Oita University
2002.5-2008.6, Associate Professor, Department of Pharmacoepidemiology, Kyoto
2008.7-2009.9, Associate Professor, Department of Data Science, The Institute of
2009.10-2013.3, Professor, Department of Data Science, The Institute of Statistical
2013.4-present, Professor, Department of Biostatistics, Nagoya University Graduate
Research Themes: Design and analysis of clinical studies, Analysis of genomic data
Research on biostatistical methodologies:
1. Matsui S, Ohashi Y. (1999). Analysis of recurrent events: Application to a clinical trial of colony
stimulating factor with the endpoint of febrile neutropenia. Statistics in Medicine, 18,
2. Matsui S, Miyagishi H. (1999). Design of clinical trials for recurrent events with periodic
monitoring. Statistics in Medicine, 18, 3005-3020.
3. Matsui S. (2004). Analysis of times to repeated events in two-arm randomized trials with
noncompliance and early withdrawal. Biometrics, 60, 965-976.
4. Matsui S. (2005). Sample size calculations for comparative clinical trials with over-dispersed
Poisson process data. Statistics in Medicine, 24, 1339-1356.
5. Matsui S. (2005). Stratified analysis in randomized trials with noncompliance. Biometrics, 61,
6. Matsui S. (2006). Reducing false positive findings in statistical analysis of pharmacogenomic
biomarker studies using high-throughput technologies. Current Drug Safety, 1, 135-141.
7. Matsui S. (2006). Predicting survival outcomes using subsets of significant genes in prognostic
marker studies with microarrays. BMC Bioinformatics, 7, 156.
8. Matsui S, Ito M, Nishiyama H, Uno H, Kotani H, Watanabe J, Guilford P, Reeve A, Fukushima
M, Ogawa O. (2007). Genomic characterization of multiple clinical phenotypes of cancer using
multivariate linear regression models. Bioinformatics, 23, 732-738.
9. Matsui S, Zeng S, Yamanaka T, Shaughnessy J. (2008). Sample size calculations based on
ranking and selection in microarray experiments. Biometrics, 64, 217-226.
10. Matsui S, Yamanaka T, Barlogie B, Shaughnessy J, Crowley J. (2008). Clustering of significant
genes in prognostic studies with microarrays: application to a clinical study for multiple
myeloma. Statistics in Medicine, 27, 1106-1120.
11. Matsui S, Oura T. (2009). Sample sizes for a robust ranking and selection of genes in microarray
experiments. Statistics in Medicine, 28, 2801-2816.
12. Oura T, Matsui S, Kawakami K. (2009). Sample size calculations for controlling the distribution
of false discovery proportion in microarray experiments. Biostatistics, 10, 694-705.
13. Noma H, Matsui S, Omori T, Sato T. (2010). Bayesian ranking and selection methods using
hierarchical mixture models in microarray studies. Biostatistics, 11, 281-289.
14. Noma H, Matsui S. (2010). Optimality of gene ranking based on univariate P-values for
detecting differentially expressed genes. Japanese Journal of Biometrics, 31, 13-21.
15. Matsui S, Noma H. (2011). Estimation and selection in high-dimensional genomic studies for
developing molecular diagnostics. Biostatistics, 12, 223-233.
16. Matsui S, Noma H. (2011). Estimating effect sizes of differentially expressed genes for power
and sample size assessments in microarray experiments. Biometrics, 67, 1225-1235.
17. Noma H, Matsui S. (2012). The optimal discovery procedure in multiple significance testing: an
empirical Bayes approach. Statistics in Medicine, 31, 165-176.
18. Matsui S, Simon R, Qu P, Shaughnessy J, Barlogie B, Crowley J. (2012). Developing and
validating continuous genomic signatures in randomized clinical trials for predictive medicine.
Clinical Cancer Research, 18, 6065-6073.
19. Noma H, Matsui S. (2013). Empirical Bayes ranking and selection methods via semiparametric
hierarchical mixture models in microarray studies. Statistics in Medicine, 32, 1904-1916.
20. Mori K, Oura T, Noma H, Matsui S. (2013). Cancer outlier analysis based on mixture modeling
of gene expression data. Computational and Mathematical Methods in Medicine, Article ID:
21. Noma H, Matsui S. (2013). An empirical Bayes optimal discovery procedure based on
semiparametric hierarchical mixture models. Computational and Mathematical Methods in
22. Matsui S. (2013). Genomic biomarkers for personalized medicine: development and validation
in clinical studies. Computational and Mathematical Methods in Medicine, Article ID: 865980.
23. Shinohara M, Toyokuni S, Morimoto T, Matsui S, Honjo T, Shinohara T. (2003). Functional
assessment of self-renewal activity of male germline stem cells following cytotoxic damage and
serial transplantation. Biology of Reproduction, 68, 1801-1807.
24. Matsui S, Sadaike T, Hamada C, Fukushima M. (2005). Creutzfeldt-Jakob disease and cadaveric
dura mater grafts in Japan: an updated analysis of incubation time. Neuroepidemiology, 24,
25. Sakai R, Matsui S, Fukushima M, Yasuda H, Miyauchi H, Miyachi Y. (2005). Prognostic factor
analysis for plaque psoriasis. Dermatology, 211, 103-106.
26. Watanabe D, Suzuma K, Matsui S, Kurimoto M, Kiryu J, Kita M, Suzuma I, Ohashi H, Ojima T,
Murakami T, Kobayashi T, Masuda S, Nagao M, Yoshimura N, Takagi H. (2005). Erythropoietin
as a retinal angiogenic factor in proliferative diabetic retinopathy. New England Journal of
27. Manzoni P, Maestri A, Gomirato G, Takagi H, Watanabe D, Matsui S. (2005). Erythropoietin as
a retinal angiogenic factor. New England Journal of Medicine, 353, 2190-2191; author reply
28. Nishimura T, Tada H, Nakagawa M, Teramukai S, Matsui S, Fukushima M. (2006). Lessons
from gefitinib-induced interstitial lung disease in Japan and proposal for the prevention of
serious drug-induced suffering: Problems in approval, pharmacovigilance, and regulatory
decision-making procedures. Pharmacy Practice, 4, 168-178.
29. Ito M, Nishiyama H, Kawanishi H, Matsui S, Guilford P, Reeve A, Ogawa O. (2007).
P21-activated kinase 1: a new molecular marker for intravesical recurrence after transurethral
resection of bladder cancer. Journal of Urology, 178, 1073-1079.
30. Tada H, Matsui S, Kawahara M, Hosoe S, Hamada C, Fukushima M. (2008). Efficacy, toxicity
and cost analysis for non-platinum triplet (gemcitabine and vinorelbine followed by docetaxel)
vs. platinum-based chemotherapy in IIIB/IV non-small cell lung cancer: Single institution
experience. European Journal of Cancer Care, 17, 120-126.
31. Tsubouchi M, Morishita R, Tabata Y, Matsui S, Kawakami K. (2008). Critical issues for
effective collaboration between academia and industry in the field of regenerative medicine in
Japan. Regenerative Medicine, 3, 497-504.
32. Tsubouchi M, Matsui S, Banno Y, Kurokawa K, Kawakami K. (2008). Overview of the clinical
application of regenerative medicine products in Japan. Health Policy, 88, 62-72.
33. Yamashita S, Hbujo H, Arai H, Harada-Shiba M, Matsui S, Fukushima M, Saito Y, Kita T,
Matsuzawa Y. (2008). Long-term probucol treatment prevents secondary cardiovascular events:
a cohort study of patients with heterozygous familial hypercholesterolemia in Japan. Journal of
Atherosclerosis Thrombosis, 15, 292-303.
34. Yamaguchi K, Mandai M, Oura T, Matsumura N, Hamanishi J, Baba T, Matsui S, Murphy SK,
Konishi I. (2010). Identification of an ovarian clear cell carcinoma gene signature that reflects
inherent disease biology and the carcinogenic processes. Oncogene, 29, 1741-1752.
35. Yoshimura K, Kamoto T, Ogawa O, Matsui S, Tsuchiya N, Tada H, Murata K, Yoshimura K,
Habuchi T, Fukushima M. (2010). Medical mushrooms used for biochemical failure after radical
treatment for prostate cancer: An open-label study. International Journal of Urology, 17,
36. Matsumura N, Mandai M, Okamoto T, Yamaguchi K, Yamamura S, Oura T, Baba T, Hamanishi
J, Kang HS, Matsui S, Mori S, Murphy SK, Konishi I. (2010). Sorafenib efficacy in ovarian
clear cell carcinoma revealed by transcriptome profiling. Cancer Science, 101, 2658-2663.
37. Sugano K, Matsumoto Y, Itabashi T, Abe S, Sakaki N, Ashida K, Mizokami Y, Chiba T, Matsui
S, Kanto T, Shimada K, Uchiyama S, Uemura N, Hiramatsu N. for the Lansoprazole Ulcer
Prevention Study Group (Low-Dose Aspirin Therapy). (2011). Lansoprazole for secondary
prevention of gastric or duodenal ulcers associated with long-term low-dose aspirin therapy:
Results of a prospective, multicenter, double-blind, randomized, double-dummy, active-control
trial. Journal of Gastoroenterogy, 46, 724-735.
38. Shoji S, Suzuki M, Tomono Y, Bockbrader HN, Matsui S. (2011). Population pharmacokinetics
of pregabalin in healthy subjects and patients with postherpetic neuralgia or diabetic peripheral
neuropathy. British Journal of Clinical Pharmacology, 72, 63-76.
39. Sugano K, Kontani T, Katsuo S, Takei Y, Sakaki N, Ashida K, Mizokami Y, Asaka M, Matsui S,
Kanto T, Soen S, Takeuchi T, Hiraishi H, Hiramatsu N. (2012). Lansoprazole for secondary
prevention of gastric or duodenal ulcers associated with long-term non-steroidal
anti-inflammatory drug (NSAID) therapy: Results of a prospective, multicenter, double-blind,
randomized, double-dummy, active-controlled trial. Journal of Gastroenterology, 47, 540-552.
40. Negoro H, Kanematsu A, Doi M, Suadicani SO, Matsuo M, Imamura M, Okinami T, Nishikawa
N, Oura T, Matsui S, Seo K, Tainaka M, Urabe S, Kiyokage E, Todo T, Okamura H, Tabata Y,
Ogawa O. (2012). Involvement of urinary bladder Connexin43 and the circadian clock in
coordination of diurnal micturition rhythm. Nature Communications, 3: 809.
41. Ishiguro M, Mochizuki H, Tomita N, Shimada Y, Takahashi K, Kotake K, Watanabe M,
Kanemitsu Y, Ueno H, Ishikawa T, Uetake H, Matsui S, Teramukai S, Sugihara K. (2012). Study
protocol of the SACURA trial: a randomized phase III trial of efficacy and safety of UFT as
adjuvant chemotherapy for stage II colon cancer. BMC Cancer, 12:281.
42. Sakaki N, Ashida K, Mizokami Y, Asaka M, Matsui S, Kanto T, Hiraishi H, Hiramatsu N,
Sugano K. (2012). Endoscopic evaluation of non-steroidal anti-inflammatory drug
(NSAID)-induced gastric and duodenal ulcers during prophylaxis with lansoprazole. Journal of
Gastroenterology and Hepatology Research, 1, 260-265.
43. Kokubo T, Matsui S, Ishiguro M. (2013). Meta-analysis of oro-cecal transit time in fasting
subjects. Pharmaceutical Research, 30, 402-411.
44. Atagi S, Katakami N, Yoshioka H, Fukuoka M, Kudoh S, Ogiwara A, Imai M, Ueda M, Matsui
S. (2013). Nested case control study of proteomic biomarkers for interstitial lung disease in
Japanese patients with non-small-cell lung cancer treated with erlotinib: a multicenter phase 4
study (JO21661). Clinical Lung Cancer, 14, 407-417.
45. Tsuchiya N, Matsui S, Narita S, Kamba T, Mitsuzuka K, Hatakeyama S, Horikawa Y, Inoue T,
Saito S, Ohyama C, Arai Y, Ogawa O, Habuchi T. (2013). Distinct cancer-specific survival in
metastatic prostate cancer patients classified by a panel of single nucleotide polymorphisms of
cancer-associated genes. Genes & Cancer (In press).
1. Matsui S. (2006). Statistical applications using DNA microarrays for cancer diagnosis and
prognosis, Handbook of Statistics in Clinical Oncology, 2nd edn. (eds J.J. Crowley and D.P.
2. Matsui S, Noma H. (2012). Analysis of DNA microarrays, Handbook of Statistics in Clinical
Oncology, 3rd edn. (eds JJ. Crowley and A Hoering), CRC Press, Boca Raton.
3. Noma H, Matsui S. (2012). Bayesian Ranking and Selection Methods in Microarray Studies,
Statistical Diagnostics for Cancer. (eds M. Dehmer and F. Emmert-Streib), Wiley.
4. Matsui S, Nonaka T, Choai Y. (2013). Design of phase III clinical trials with predictive
biomarkers for personalized medicine. Developments in Statistical Evaluation of Clinical Trials,
5. Hirakawa A, Matsui S. (2013). Dose-finding for two-agent combination phase I trials.
Developments in Statistical Evaluation of Clinical Trials, Springer. (In press)
6. Matsui S, Buyse M, Simon R. Design and Analysis of Clinical Trials for Predictive Medicine.
International Biometric Society, American Statistical Association, Japan Statistical
Society, The Biometric Society of Japan, Japanese Society of Applied Statistics,
Visiting Researcher, Translational Research Informatics Center, Foundation for
Biomedical Research and Innovation (2002-present)
The International Biometric Society, Representative Council Member (2011-2014),
Current Drug Safety Editorial Board (2005-present)
Japanese Journal of Clinical Oncology Review Board (2005-present)
The Biometric Society of Japan, Director (2007-2014)
Japanese Journal of Biometrics, Editor-in-chief (2009-2014)
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Bramford to Twinstead Tee Connection Project Notes to accompany Biodiversity baseline information The biodiversity information consists of two sets of plans. The first set of plans (G1980.297d – 302d) illustrates the findings of the habitat survey work undertaken by TEP along the preferred route corridor. This survey has been carried out using a combination of access to land (where this has b