Programme*

Optional introduction to probability and statistics

Tuesday 7 December 2021

13.30 Registration
14.00
Introduction to statistical methods (Part I)
15.20 Coffee break
15.40
Introduction to statistical methods (Part II)
17.00 End day 1 of Optional Introduction

Wednesday 8 December 2021

08.30
Discussion of homework from Tuesday
08.50 End of Optional Introduction

Course

Wednesday 8 December 2021

Principles of comparative clinical trials

08.30 Registration and welcome coffee
09.00
Welcome and introduction
09.15
General statistical principles
10.05
Statistical analysis of time to event endpoints
10.50 Coffee break
11.10
The role of competing risks in survival analysis
11.50
Trial endpoints and design of phase III trials
12.40 Lunch
13.30
Sample size for phase III trials
14.20
Problems and pitfalls of data analysis and interpreting results
15.10 Coffee break
15.30
Quality of Life
16.20
Quiz
Moderator: Saskia Litière
17.00 End day 1

Thursday 9 December 2021

Advanced methods for phase III trials

Chair: Jan Bogaerts
08.30
Stat Clinic I
Homework: Paper discussion
09.30
Interim data monitoring and early stopping rules (with discussion)
10.30 Coffee break
10.50
Stat Clinic II
IDMC: What would you recommend?
12.10
Wrap up of Stat Clinic II (IDMC)
Moderator: Jan Bogaerts
12.30 Lunch

Exploratory studies

Chair: Jan Bogaerts
13.30
Design and analysis of phase I studies
14.20
Phase II designs without biomakers
15.10 Coffee break
15.30
Biomarker development, diagnostic tests and gene signatures
16.20
Quiz
Moderator: Jan Bogaerts
17.00 End day 2

Friday 10 December 2021

Exploratory studies and adaptive designs

08.30
Bayesian approach to clinical trial design
09.20
Biomarker based study designs
10.10 Coffee break
10.30
Adaptive trials
11.20
Systematic reviews and meta-analyses
12.10 Lunch
13.10
Stat Clinic III
Parallel workshops on different topics
14.40 Coffee break
15.00
Stat Clinic IV (Workshops)
Parallel workshops on different topics
16.30
Views towards the future (data sharing with or without limits?)
17.00 End of course

* Programme is subject to change