Programme*

Optional introduction to probability and statistics

Tuesday 13 June 2023

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 14 June 2023

08.30
Discussion of homework from Tuesday
08.50 End of Optional Introduction

Course

Wednesday 14 June 2023

Principles of comparative clinical trials

08.00 Registration and welcome coffee
09.00
Welcome and introduction
09.15
General statistical principles
10.15
Statistical analysis of time to event endpoints (I)
10.45 Coffee break
11.05
Statistical analysis of time to event endpoints (II)
11.35
Trial endpoints and design of phase III trials
12.35 Lunch
13.30
Sample size for phase III trials
14.30
Problems and pitfalls of data analysis and interpreting results (I)
15.00 Coffee break
15.20
Problems and pitfalls of data analysis and interpreting results (II)
15.50
Quiz
Moderator: Saskia Litière
16.30 Networking reception
18.00 End day 1

Thursday 15 June 2023

Advanced methods for phase III trials

09.00
Stat Clinic I
Homework: Paper discussion
09.30
Interim data monitoring and early stopping rules (with discussion)
10.30 Coffee break
10.50
Introduction to Stat Clinic II (IDMC)
Moderator: Matthew Sydes
11.10
Stat Clinic II
IDMC: What would you recommend?
12.10
Wrap up of Stat Clinic II (IDMC)
Moderator: Matthew Sydes
12.30 Lunch

Exploratory studies

13.30
Design and analysis of phase I studies
14.20
Phase II designs without biomarkers
15.10 Coffee break
15.30
Biomarker based study designs
16.20
Quiz
Moderator: Murielle Mauer
17.00 End day 2

Friday 16 June 2023

Exploratory studies and adaptive designs

09.00
Stat Clinic II
Homework: Paper discussion
09.30
Quality of life
10.30 Coffee break
10.50
Adaptive trials
11.50
Systematic reviews and meta-analyses
12.50 Lunch
14.00
Stat Clinic III
Parallel workshops on selected topics
15.00 Coffee break
15.20 Stat Clinic IV

Parallel workshops on selected topics
16.20
Views towards the future
16.50
Closing remarks

* Programme is subject to change