臨床試驗設計與資料分析
Instructor: 歐士田 (Austin)
Date: 2011/02/22
Place: National Taipei University
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Austin’s resume
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Education
淡江大學數學系數統組 (Bachelor)
 美國德州農工大學統計所 (Master and Ph. D.)
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Working experience
靜宜應數系 (1994~2000)
 淡江統計系 (2000~2003)
 醫藥品查驗中心 (CDE, 2003-2005/8)
 台北大學統計系 (2005/8~)
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Austin’s resume
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Hobbies
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Reading in Statistics
Exercises
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Basketball
Badminton
Swimming
Jogging
Tennis and Table Tennis
Life exploration
E-mail: stou@mail.ntpu.edu.tw
Web site: http://web.ntpu.edu.tw/~stou/
Office phone numbers
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26748189-66765 (三峽);
25024654-18287 (台北)
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Practical questions for
statisticians
Do you have the experience on sharing
the statistical knowledge with nonstatisticians?
 Do you prepare for learning new
knowledge different from statistics?
 Do you have the well communication and
character to deal with people from other
fields?
 Do you read English smoothly?
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Expectations learned from this
course
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B.
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D.
E.
Background for clinical trials
Statistical principles for clinical trials
Statistical considerations in clinical
trials
Protocol designs for clinical trials
Statistical methodologies in clinical
trials
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Course evaluations
Attendance (10%)
 Midterm and final reports (45% for each,
team work)
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References
C.R. Buncher and J.Y. Tsay (1994), “Statistics in
the pharmaceutical industry”, Marcel Dekker.
 S.C. Chow and J.P. Liu (1998), “Design and
analysis of clinical trials”, John Wiley.
 L.M. Friedman, C.D. Furberg, and D.L. DeMets
(1998), “Fundamental of clinical trials”, Springer.
 S. Piantadosi (2005), “Clinical trials- a
methodologic perspective”, Wiley.
 ICH E9, “Statistical principles for clinical trials”.
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Useful web sites
ClinicalTrials.gov : clinicaltrials.gov
 USA Food and Drug Administration
(FDA): http://www.fda.gov
 EMEA: http://www.emea.europa.eu
 Taiwan FDA: http://www.fda.gov.tw/
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First assignment (team work)
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Find the paper or report for publishing
the results of clinical trials, and have a
look at it.
Present a report consisting of
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things appeared in the paper are related to
statistics;
feeling about the clinical trials;
Special or new things to you.
Due date: 2/25/2008
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