1 臨床試驗設計與資料分析 Instructor: 歐士田 (Austin) Date: 2011/02/22 Place: National Taipei University

2 Austin’s resume 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.) Working experience 靜宜應數系 (1994~2000) 淡江統計系 (2000~2003) 醫藥品查驗中心 (CDE, /8) 台北大學統計系 (2005/8~)

3 Austin’s resume Hobbies Reading in Statistics Exercises Basketball Badminton Swimming Jogging Tennis and Table Tennis Life exploration Web site: Office phone numbers ( 三峽 ); ( 台北 )

4 Practical questions for statisticians Do you have the experience on sharing the statistical knowledge with non- statisticians? 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?

5 Expectations learned from this course A. Background for clinical trials B. Statistical principles for clinical trials C. Statistical considerations in clinical trials D. Protocol designs for clinical trials E. Statistical methodologies in clinical trials

6 Course evaluations Attendance (10%) Midterm and final reports (45% for each, team work)

7 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”.

8 Useful web sites ClinicalTrials.gov : clinicaltrials.gov USA Food and Drug Administration (FDA): EMEA: Taiwan FDA:

9 First assignment (team work) Find the paper or report for publishing the results of clinical trials, and have a look at it. Present a report consisting of 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