Monday
Implementing the CONSORT statement: not as simple as it looks
Jacobus Lubsen
SOCAR Research, Nyon, Switzerland.
Tuesday & Wednesday
Tim Clayton
Department of Medical Statistics
Unit London School of Hygiene and Tropical Medicine, UK
Tuesday
Monitoring trial data and interim analysis.
- To understand the ethical difficulties in deciding whether to stop a clinical trial early based on interim results
- To discuss the role and importance of independent Data Monitoring Committees in monitoring interim trial data
- To explain the difficulties and problems of stopping clinical trials early
Wednesday
Alternative trial designs, and multiplicity and reporting issues.
Wednesday (am):
- To explain the principal design features of factorial, equivalence and crossover trials
- To understand that sample size and analysis methods depend on the design of the trial
- To understand the concept of an adaptive design and give examples of different types of adaptive design
Wednesday (pm):
- To explain what is meant by multiplicity of data
- To understand the problems associated with multiplicity of data in interpreting results
- To understand the importance of maintaining the highest standards in reporting clinical trial results
Thursday
Analysis populations, composite endpoints and estimation of other parameters of treatment effect from published reports
Jacobus Lubsen
SOCAR Research, Nyon, Switzerland
and Erasmus Medical Centre, Rotterdam
Friday
Design and analysis of cluster randomised trials
Mike Campbell
ScHARR University of Sheffield, UK.
Objectives:
- To explain the idea of cluster randomised trials
- Understand the principles of sample size calculations for cluster trials
- To show how to do simple analyses of cluster randomised trials