391 Comment: is the title (“Impact on trial and conduct”) correct? ‘sign’ Proposed change: Should be ‘sign’ ‘design’? 393 Comment: Would it only be the primary trial objectives? As stated later in the addendum it is important that the study is designed appropriately for the secondary (including safety) objectives too. Please provide clarity on what is intended by primary objectives We interpret this – to mean primary and key secondary endpoints for which a labelling claim will be made is this correct? – Proposed change (if any): Please clarify that this applies to key secondary endpoints too. 408 assumptions and, depending on the proportion of missing data; this “untestable may undermine the…” Comment: There is a typo (comma, not colon) Proposed change (if any): change to depending on the proportion of missing “and, data, this” 409 Comment: It seems not easy to distinguish events” and “intercurrent “residual missing data”. Proposed change (if any): Consider adding more examples of what would be considered missing data”. “residual
391 Comment: is the title (“Impact on trial ‘sign’ and conduct”) correct? Proposed change: Should ‘sign’ be ‘design’? 393 Comment: Would it only be the primary trial objectives? As stated later in the addendum it is important that the study is designed appropriately for the secondary (including safety) objectives too. Please provide clarity on what is intended by primary objectives – We interpret this to mean primary and key secondary endpoints for which a labelling claim will be made – is this correct? Proposed change (if any): Please clarify that this applies to key secondary endpoints too. 408 “untestable assumptions and, depending on the proportion of missing data; this may undermine the…” Comment: There is a typo (comma, not colon) Proposed change (if any): change to “and, depending on the proportion of missing data, this” 409 Comment: It seems not easy to distinguish “intercurrent events” and “residual missing data”. Proposed change (if any): Consider adding more examples of what would be considered “residual missing data”.
ema-e9-consolidated-feedback-18feb08.docx