Programme*

Optional introduction to probability and statistics

Tuesday 14 June 2022

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 15 June 2022

08.30
Discussion of homework from Tuesday
08.50 End of Optional Introduction

Course

Wednesday 15 June 2022

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 Networking reception
18.30 End day 1

Thursday 16 June 2022

Advanced methods for phase III trials

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
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 development, diagnostic tests and gene signatures
16.20
Quiz
Moderator: Murielle Mauer
17.00 End day 2

Friday 17 June 2022

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
Machine Learning for biomarker discovery – a case study from digital pathology
14.00
Stat Clinic III
Parallel workshops on different topics
15.00 Coffee break
15.20
Stat Clinic IV (Workshops)
Parallel workshops on different topics
16.20
Views towards the future
17.00 End of course

* Programme is subject to change