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
Chair: Saskia Litière
| 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
Chair: Murielle Mauer
| 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
Chair: Murielle Mauer
| 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
Chair: Xavier Paoletti
| 09.00 | |
| 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