EORTC AISBL / IVZW
Avenue Mounierlaan, 83/11
Brussel 1200 Bruxelles • Belgie Belgique
+32 2 774 16 11

  EORTC course on: CLINICAL TRIAL STATISTICS FOR NON STATISTICIANS
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11 - 14 June 2013
Crowne Plaza Brussels - Le Palace
3 rue Gineste, 1210 Brussels, Belgium


 
Program
  
OPTIONAL  INTRODUCTION
 
Tuesday 11 June 2013
  13.30 - 14.00 Registration
  14.00 - 15.20
Introduction to statistical methods (Part I); S. Litière
  15.20 - 15.40
Coffee break
  15.40 - 17.00
Introduction to statistical methods (Part II); S. Litière
  Wednesday 12 June 2013
  08.30 - 08.50 Discussion of homework from Tuesday; S. Litière
 
COURSE
  Wednesday 12 June 2013: Principles of comparative clinical trials (Chair: L. Collette)
 

08.30 - 09.00

Registration and welcome coffee

 


12.30 - 13.30


Lunch
 
09.00 - 09.10
Welcome and intoduction
L. Collette
 
13.30 - 14.20
General statistical principles II (bias, ITT, multiple tests)
T. Gorlia
 
09.10 - 09.40
General statistical principles I (clinical trials, hypothesis tests)
S. Collette
 
14.20 - 15.10
Sample size for phase III trials
C. Legrand
 
09.40 - 10.40
Statistical analysis of time to event endpoints
H. Putter
 
15.10 - 15.30
Coffee break
 
10.40 - 11.00
Coffee break  
15.30 - 16.30
Reporting and interpreting results
L. Collette
 
11.00 - 12.00
Trial endpoints and design of phase III trials
J. Bogaerts
 
16.30 - 17.00
Moderated discussion with audience II
Moderators: J. Bogaerts, S. Collette
 
12.00 - 12.30
Moderated discussion with audience I
Moderator: L. Collette
     
           
  Thursday 13 June 2013: Advanced methods for phase III trials (Chair: J. Bogaerts)
 

08.30 - 09.30


Practical examples: Reporting of results

T. Gorlia, C. Coens

 

12.30 - 13.30

Lunch
 
09.30 - 10.20
Prognostic factor models
D. Rizopoulos
 
13.30 - 14.20

Interim data monitoring and early stopping rules
(with discussion); M. Sydes

 
10.20 - 10.40
Coffee break  
14.20 - 15.20
Quality of Life (with discussion);
C. Coens
 
10.40 - 11.25
Diagnostic tests and gene signatures
S. Michiels
 
15.20 - 15.40
Coffee break
 
11.25 - 12.10
Predictive factors & targeted agent phase III studies
S. Michiels
 
15.40 - 17.40
Workshop I
IDMC: What would you recommend?
M. Sydes, L. Collette, J. Bogaerts
 
12.10 - 12.30
Moderated discussion with audience III
Moderator: J. Bogaerts
 
19.30

Course dinner (optional)

  Friday 14 June 2013: Exploratory studies and adaptive designs (Chair: M. Sydes)
 

08.30 - 09.00

Exploratory versus confirmatory studies

J. Bogaerts
 

12.30 - 13.30

Lunch
 
09.00 - 10.00
Design & analysis of phase I studies
S. Zohar
 
13.30 - 14.00
Bayesian approaches to phase I & II
S. Zohar
 
10.00 - 10.30
Coffee break  
14.00 - 15.00
Workshop II
Topics to choose from:
 
10.30 - 11.15
Classical phase II designs, binary endpoints
C. Fortpied
    A. Phase I / II trials; S. Zohar, J. Paul
B. Prognostic / Predictive factors; S. Litière, M. Mauer, L. Slaets
 
11.15 - 12.00

Novel phase II designs using biomarkers
J. Paul

 
15.00 - 15.20
Coffee break
 
12.00 - 12.30

Moderated discussion with audience IV
Moderator: L. Collette

 
15.20 - 16.20
Adaptive trial designs
M. Mauer
       
16.20 - 16.30
Conclusions and close
Chairs
     Conflicts of Interest Disclosures are available here
 

Last update: 8 February 2013