1. Sample Size Estimation and Re- Estimation Break-out Session

2. Format of the Session 14.30 – 14.40 Formation of groups to discuss topics. Identify spokesperson to feedback 14.40 – 15.30 Discussions 15.30 – 16.00 Feedback on issues raised during discussions

3. Topics for Discussion Group 1 (Lucy) Covariate adjustment in sample size estimation Group 2 (Nick) Accounting for missing data or treatment cross-over when sample-sizing Group 3 (Emma) Appropriate techniques for sample-size re- estimation Group 4 (Sue) Sample sizing for multiple endpoints

4. Issues to consider Is additional complexity warranted? Communicating relevant information Simulation versus calculation Need for guidelines? Software