Design and analysis of clinical studies for personalized medicine

2010 Fiscal Year Final Research Report

• Project/Area Number: 20590599
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Single-year Grants
• Section: 一般
• Research Field: Hygiene
• Research Institution: The Institute of Statistical Mathematics
• Principal Investigator: MATSUI Shigeyuki The Institute of Statistical Mathematics, データ科学研究系, 教授 (80305854)
• Co-Investigator(Kenkyū-buntansha): MORITA Satoshi 横浜市立大学, 医学研究科, 教授 (60362480)
• Co-Investigator(Renkei-kenkyūsha): YAMANAKA Takeharu 九州がんセンター, 臨床研究部, 室長 (00325466) ; DAIMON Takashi 兵庫医科大学, 医学部, 講師 (40372156)
• Project Period (FY): 2008 – 2010
• Keywords: 医学統計 / ゲノム薬理学

Research Abstract

Development of molecular diagnostics is essential for establishing personalized medicine based on genetic characteristics of individual patients. In this research, we studied design and analysis of clinical studies for developing molecular diagnostics. In particular, we developed statistical methods for identifying molecular markers associated with clinical variables such as disease type, response to treatment, and survival outcomes, from a large pool of candidate molecular markers, making prediction systems using the identified molecular markers, and testing their clinical utility.

Research Products

• [Journal Article] Estimation and selection in high-dimensional genomic studies for developing molecular diagnostics. (2011)
  • Author(s): Matsui S, Noma H
  • Journal Title: Biostatistics 12巻 Pages: 223-233
  • Peer Reviewed
• [Journal Article] Optimality of gene ranking based on univariate P-values for detecting differentially expressed genes. (2010)
  • Author(s): Noma H, Matsui S
  • Journal Title: Japanese Journal of Biometrics. 31巻 Pages: 13-21
  • Peer Reviewed
• [Journal Article] Evaluating the impact of prior assumptions in Bayesian biostatistics. (2010)
  • Author(s): Morita S, Thall PF, Muller P
  • Journal Title: Statistics in Biosciences 2巻 Pages: 1-17
  • Peer Reviewed
• [Journal Article] Sample sizes for a robust ranking and selection of genes in microarray experiments. (2009)
  • Author(s): Matsui S, Oura T
  • Journal Title: Statistics in Medicine 28巻 Pages: 2801-2816
  • Peer Reviewed
• [Journal Article] Sample size calculations for controlling the distribution of false discovery proportion in microarray experiments. (2009)
  • Author(s): Oura T, Matsui S, Kawakami K
  • Journal Title: Biostatistics 10巻 Pages: 694-705
  • Peer Reviewed
• [Journal Article] A Bayesian hierarchical mixture model for platelet derived growth factor receptor phosphorylation to improve estimation of progression-free survival in prostate cancer. (2009)
  • Author(s): Morita S, Thall PF, Bekele BN, Mathew P
  • Journal Title: Journal of the Royal Statistical Society(Series C (Applied Statistics)) 59巻 Pages: 19-34
  • Peer Reviewed
• [Journal Article] North East Japan Gefitinib Study Group. First-line gefitinib for patients with advanced non-small-cell lung cancer harboring epidermal growth factor receptor mutations without indication for chemotherapy. (2009)
  • Author(s): Inoue A, Kobayashi K, Usui K, Maemondo M, Okinaga S, Mikami I, Ando M, Yamazaki K, Saijo Y, Gemma A, Miyazawa H, Tanaka T, Ikebuchi K, Nukiwa T, Morita S, Hagiwara K
  • Journal Title: Journal of Clinical Oncology 27巻 Pages: 1394-1400
  • Peer Reviewed
• [Journal Article] Sample size calculations based on ranking and selection in microarray experiments. (2008)
  • Author(s): Matsui S, Zeng S, Yamanaka T, Shaughnessy J
  • Journal Title: Biometrics 64巻 Pages: 217-226
  • Peer Reviewed
• [Journal Article] Clustering of significant genes in prognostic studies with microarrays : application to a clinical study for multiple myeloma. (2008)
  • Author(s): Matsui S, Yamanaka T, Barlogie B, Shaughnessy JD Jr, Crowley J
  • Journal Title: Statistics in Medicine 27巻 Pages: 1106-1120
  • Peer Reviewed
• [Presentation] がんの分子診断マーカーの臨床開発:現状と課題 (2010)
  • Author(s): 松井茂之
  • Organizer: 統計関連学会連合大会
  • Place of Presentation: 早稲田大学(招待講演)
  • Year and Date: 2010-09-07
• [Presentation] Results of a phase II multicenter study of neoadjuvant S-1 and irinotecan in patients with locally advanced gastric cancer. (2010)
  • Author(s): Terashima M, Saze Z, Hosoya A, Takahashi M, Takagane A, Hachiya O, Koeda K, Matsui S, Kusunoki Y, Oohashi W, Fukushima M, Gotoh M
  • Organizer: 2010 Gastrointestinal Cancers Symposium. The American Society of Clinical Oncology
  • Place of Presentation: Orlando, Florida.
  • Year and Date: 2010-01-22
• [Presentation] がんの分子診断研究:FDRは有用か? (2008)
  • Author(s): 松井茂之
  • Organizer: 2008年度日本計量生物学会年会特別セッション
  • Place of Presentation: 筑波大学
  • Year and Date: 2008-06-05
• [Presentation] Gefitinib combined survival analysis of the mutation positives from the prospective phase II trials (I-CAMP). (2008)
  • Author(s): Morita S.
  • Organizer: American Society of Clinical Oncology.
  • Place of Presentation: Chicago.
  • Year and Date: 2008-05-30
• [Remarks] ホームページ等