統計生活專題

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臨床試驗設計與資料分析
Instructor: 歐士田 (Austin)
Date: 2011/02/22
Place: National Taipei University
1
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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2
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: [email protected]
Web site: http://web.ntpu.edu.tw/~stou/
Office phone numbers
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26748189-66765 (三峽);
25024654-18287 (台北)
3
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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4
Expectations learned from this
course
A.
B.
C.
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
5
Course evaluations
Attendance (10%)
 Midterm and final reports (45% for each,
team work)
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6
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
9
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