|
週次 |
日期 |
單元主題 |
|
第1週 |
9/27 |
Introduction and course overview（請於課前閱讀本篇文章，於課堂中討論） |
|
第2週 |
10/4 |
Randomization and sample size estimation
|
|
第3週 |
10/18 |
End point selection
|
|
第4週 |
10/25 |
Early phase trials I
|
|
第5週 |
11/01 |
Early phase trials II |
|
第6週 |
11/08 |
Comparison group(s)
|
|
第7週 |
11/15 |
Efficient trial designs |
|
第8週 |
11/22 |
Interim analysis and adaptive design, DSMB |
|
第9週 |
11/29 |
Case Report Form and Data Management
|
|
第10週 |
12/06 |
Data analysis and interpretation (I), CONSORT
|
|
第11週 |
12/13 |
Data analysis and interpretation (II)
|
|
第12週 |
12/20 |
Human Subject Protection and Research Integrity |
|
第13週 |
12/27 |
Investigator Initiated Trials
|
|
第14週 |
01/03 |
Quality control and quality assurance
|
|
第15週 |
01/10 |
Safety reporting, Development of Medical Products, Real World Evidence |