Course with Prof. Stephen Senn

The Czech National Group

of the International Society

for Clinical Biostatistics

In cooperation with

the Institute of Computer Science AS CR in Prague, and

Faculty of Mathematics and Physics at the Charles University in Prague

is delighted to invite you to attend

a 1-day course on

„Cross-over Trials“

presented by

Prof. Stephen Senn, Ph.D.

Head of the Competence Centre

for Methodology and Statistics at CRP-Santé,

Luxembourg

Where: Institute of Computer Science AS CR (in Czech: Ústav informatiky AV ČR)

Room # 318

Pod Vodárenskou věží 2

Prague 8 - Ládví (Metro red line "C", exit "Ládví")

Czech Republic

When: May 3, 2012

Registration deadline: April 15, 2012 (payment needs to be received by this date)

REGISTRATION IS NOW CLOSED!!

- Registration rates

- Payments only via bank transfer (*** all international payments need to be made in EUR ***)

All domestic (CZK) and international transfers (EUR), except Slovakia

Account number 2100009829 / 2010

Transfers from Slovakia only (EUR)

Account number 2100009829 / 8330

IBAN CZ3820100000002100009829

BIC code/SWIFT FIOBCZPPXXX

Bank name and address: Fio banka, a.s., V Celnici 1028/10, Praha 1, Czech Republic

Important!!: When you make the payment, please, send your contact information via e-mail to the address shown below for confirmation. The number of course participants is limited to 30. Should the course reach its capacity, a notification will be placed here.

Course Venue

Institute of Computer Science AS CR

Pod Vodarenskou vezi 2

182 07 Prague

Czech Republic

Contact information

Ms. Lenka Semeráková

Dept. of Medical Informatics

Institute of Computer Science AS CR

Tel. +420 266 053 640

E-mail: semerakova@cs.cas.cz

Course Outline

Cross-over Trial in Clinical Research: An Introduction

Stephen Senn, CRP-Santé, Luxembourg

Abstract

This course is based one the book with the same name and is designed to provide the attended with a basic grounding in the techniques used for analysing cross-over trials although, in fact, some of the course will cover design also. The course will be firmly practical with the emphasis on using cross-over trials to say something about the effects of treatments rather than as some sort of mathematical guinea pig. Controversies and issues will be covered as well as techniques.

1. Introduction

a. Nature and uses of cross-over trials

b. Philosophy and approaches to analysis

c. Some examples

2. The AB/BA design

a. The basic estimator approach

b. Adjusting for period effects

c. The problem of carry-over

d. Problems with the two-stage analysis

e. Analysis using proc glm and proc mixed

f. Use of baselines

3. Normal data from designs with three or more treatments

a. The degrees of freedom problem

b. Basic estimator approach

c. Analysis using proc glm and proc mixed

4. Various design issues

a. Sample size determination

b. Choosing sequences

c. Incomplete block designs

5. Mathematical approaches to carry-over

a. Reason why the simple carry-over model is not useful

b. How to adjust if you must

c. Analysis using proc glm and proc mixed

Course schedule:

8:00-9:00 Registration

9:00-12:00 Morning session (part 1-3, includes 15 min coffee break)

12:00-13:00 Lunch break

13:00-16:00 Afternoon session (part 4-5, includes 15 min coffee break)

16:10-16:30 Course evaluation