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Design and Analysis of Clinical Trials

Concept Programme

MONDAY 19 APRIL 2027

09:00 Registration
09:10 Introduction
Dr. ir. Nan van Geloven
09:15 Lecture: Design and analysis of clinical trials 1
Prof. dr. Hein Putter
10:15 Coffee break
10:30 Lecture: Design and analysis of clinical trials 2
Prof. dr. Hein Putter
11:45  Lunch break (lunch not covered)
12:45 Practical exercises: Trial analysis
Youngxi Long
14:45

Discussion exercises: Trial analysis
Dr. ir. Nan van Geloven, Yongxi Long

15:00

Lecture: Estimands and sensitivity analyses: ICH E9 Addendum
Dr. Doranne Thomassen

16:00 Coffee break
16:15 Practical exercise: Estimands 
Dr. ir. Nan van Geloven, dr. Doranne Thomassen
16:30 Lecture: Sample Size calculation
Dr. ir. Nan van Geloven
17:15 End of day 1

TUESDAY 20 APRIL 2027

09:00 Registration
09:15 Lecture: A meta look on clinical trials
Dr. Erik van Zwet
10:15 Coffee break
10:30 Practical exercise: Sample size calculation
Yongxi Long
11:45 Lunch break (lunch not covered)
12:45

Discussion exercises: Sample size calculation

Dr. ir. Nan van Geloven, Yongxi Long

13:00 Lecture: Missing data in clinical trials
Dr. ir. Nan van Geloven
14:00 Practical exercise: Missing data
Dr. ir. Nan van Geloven
14:15 Lecture: Interim analyses and DSMB
Dr. ir. Nan van Geloven
15:00 Coffee break
15:15 Lecture: Heterogeneity of treatment effect 
Dr. ir. David van Klaveren 
16:00 Practical exercise: Heterogeneity of treatment effect 
Dr. ir. David van Klaveren, Dr. ir. Nan van Geloven
17:00 Discussion exercise: Heterogeneity of treatment effect 
Dr. ir. David van Klaveren 
17:15 End of day 2

WEDNESDAY 21 APRIL 2027

all day Self study

THURSDAY 22 APRIL 2027

09:00 Registration
09:15 Lecture: Non-inferiority studies
Dr. ir. Nan van Geloven
10:00 Practical exercises: Non-inferiority incl. discussion
Dr. ir. Nan van Geloven
10:30 Coffee break
10:45 Lecture: Medical Ethical Committee
Prof. dr. Olaf Dekkers
11:45 

Evaluation
Dr. ir. Nan van Geloven

12:00 End of course