Yasuo Ohashi
Professor of Biostatistics/Epidemiology and Preventive Health Sciences, School of Health Sciences and Nursing, Graduate School of Medicine, University of Tokyo
Hideki Origasa
Professor of Biostatistics, Faculty of Medicine, Toyama Medical and Pharmaceutical University
Seiichiro Yamamoto
Researcher, Statistics and Cancer Control Division, Research Center for Cancer Prevention and Screening, National Cancer Center Research Institute
Naoki Ishizuka
Head of Preventive Medicine Research Institute, Department of Community Health and Medicine, International Medical Center of Japan
Hiroshi Nagai
Chief Researcher, Department of Clinical Study Management, Translational Research Informatics Center, Foundation for Biomedical Research and Information
Hideyo Oda
Chief Researcher, Department of Clinical Study Management, Translational Research Informatics Center, Foundation for Biomedical Research and Information
Takeharu Yamanaka
Chief Researcher, Department of Clinical Study Management, Translational Research Informatics Center, Foundation for Biomedical Research and Information
Takashi Daimon
Researcher, Department of Clinical Study Management, Translational Research Informatics Center, Foundation for Biomedical Research and Information
Masanori Fukushima
Professor of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital
Shigeyuki Matsui
Associate Professor of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University
Michael LeBlanc
SWOG & Fred Hutchinson Cancer Research Center (FHCRC), Senior Statistician
Donna Pauler- Ankerst
SWOG & FHCRC, Senior Statistician
Ping-Yu Liu
SWOG & FHCRC, Senior Statistician
Catherine Tangen
SWOG & FHCRC, Senior Statistician
Jacqueline Benedetti
SWOG & FHCRC, Coordinating Statistician
Kenneth Kopecky
SWOG & FHCRC, Senior Statistician
William Barlow
CRAB, Senior Biostatistician
Barry Storer
FHCRC Division of Public Health Sciences, Associate member
Johanna Hardin
Pomona College
John Shaughnessy
University of Arkansas for Medical Sciences
Charles Coltman Jr.
and twenty others
SWOG & Cancer Therapy and Research Center, Chairman
| 8:30am | INTRODUCTORY REMARKS
John Crowley, PhD, Masanori Fukushima, MD, Charles A Coltman Jr, MD
|
GENE EXPRESSION PROFILING ANALYSIS |
| 9:00am | Gene Expression Profiling
John Shaughnessy, PhD
| |
| 9:30am | Statistical Issues in the Analysis of GEP Data
William Barlow, PhD
| |
| 10:00am | Break | |
| 10:30am | Predicting Patient Survival from Gene Expression Data
Shigeyuki Matsui, PhD
| |
| 11:00am | Application of Microarray Analysis Methods to Epidemiological Data
Seiichiro Yamamoto, PhD
| |
| 11:30am | Using Robust Measures to Describe Distributions and Similarities of Microarray Data Johanna Hardin, PhD
| |
| 12:00pm | Lunch on your own | |
| CLINICAL TRIALS — PHASE I | ||
| 1:00pm | An Overview of Phase I Designs
Barry Storer, PhD
| |
| 1:30pm | An Application of the Continual Reassessment Method to a Study of Interferon in Patients with Adult Leukemia
Naoki Ishizuka, PhD
| |
| CLINICAL TRIALS — PHASE II | ||
| 2:00pm | Phase II Study Designs in the Southwest Oncology Group
Catherine Tangen, DrPH
| |
| 2:30pm | Phase II Selection Designs
Ping-Yu Liu, PhD
| |
| 3:00pm | Break | |
| CLINICAL TRIALS — PHASE III | ||
| 3:30pm | A Randomized Controlled Trial of a Non-Platinum Triplet for Non-Small Cell Lung Cancer
Hideki Origasa, PhD
| |
| 4:00pm | Analysis of QOL Data in Cancer Clinical Trials
Yasuo Ohashi, PhD
| |
| 4:30pm | Japan/US Common Arm Trials
John Crowley, PhD
| |
| PROGNOSTIC FACTORS AND BIOMARKERS | ||
| 9:00am | Tumor Down-Staging as an Endpoint for Evaluating Neoadjuvant Chemotherapy in Invasive Bladder Cancer
Satoshi Teramukai, PhD
| |
| 9:30am | Prediction of Skin Adverse Events due to Radiation Therapy in Breast Cancer Patients using SNPs
Eisei Oda, PhD
| |
| 10:00am | Extreme Regression
Michael LeBlanc, PhD
| |
| 10:30am | Break | |
| 11:00am | Bagging Trees with Application to Analysis of Peripheral Blood Stem Cell
Donor Data
Takashi Daimon, PhD
| |
| 11:30am | Longitudinal Analysis of Biomarker Data
Donna Pauler, PhD
| |
| 12:00pm | Closing Remarks
John Crowley, PhD, Masanori Fukushima, MD
|
Session 1: Gene Expression Profiling Analysis
A recent and important theme is to develop an analytical procedure of studies designed to determine disease type, predict prognosis and predict responses to treatments by utilizing genetic information of cancer patients. Although many biostatisticians have developed analytical procedures, there is no established one as yet. In this session, multiple myeloma and bladder cancer cases were used to provide examples of data analysis. These examples raised a common awareness among statisticians from the U.S. and Japan about the development of analytical procedure, including associated problems. In addition, Dr. Matsui obtained a certain degree of approval for his analytical procedure of genetic screening.
Session 2: Clinical Trials
Participants from the U.S. presented an overview of phase I and II clinical trials. From Japan, Dr. Ishizuka introduced the latest design of phase I trial using leukemia cases, and Dr. Ohashi referred to many analytical cases of QOL (Quality of Life) data in clinical trials. These analytical approaches seemed to provide seminar participants with much valuable information. In addition, Dr. Origasa from Japan and Dr. Crowley from the U.S. each gave a presentation on the Common Arm Trial of lung cancer conducted in SWOG and Japan (JMTO). The results, particularly those relating to adverse effects, were compared. It became clear that variation exists in the frequency of a range of adverse events between Japan and the U.S. The necessity for further studies including those focusing on genetics was commonly recognized among the participants in order to investigate reasons for these differences.
Session 3: Prognostic Factors and Biomarkers
Based on the clinical trial conducted by SWOG, Teramukai made a statement about the evaluation procedure of the preoperative chemotherapy for bladder cancer and future goals, and suggested the possibility of international studies in Japan and the U.S. for some tasks, such as development of new cancer treatments. Dr. Oda proposed his own approach to analyzing the correlation between the incidence of adverse events induced by radiotherapy and SNPs, and it was highly evaluated. Dr. Daimon proposed a computer intensive analytical method for exploring the risk groups for adverse drug effects. Dr. LeBlanc and Dr. Pauler from the U.S. introduced the latest original analytical methods. Based on the relevance of their work, it seems sufficiently feasible to develop new approaches in collaboration with them in the future.
As a whole, this seminar was a great success as the participants were able to engage in active and meaningful discussions. The seminar was extremely significant for the ongoing development of clinical research/trials in cancer and biostatistics in Japan.
September 22, 2004 18:00~ Reception Dinner (Number of participants from Japan:10/U.S:15)
September 23, 2004 18:00~ Dinner (Number of participants from Japan:11/U.S:15)
September 24, 2004 12:00~ Study Tour to Cancer Research and Biostatistics (CRAB) (Number of participants from Japan: 6)
September 24, 2004 16:30~ Dinner Event (Number of participants from Japan:10/U.S:10)