Strict eligibility criteria |
Broaden eligibility criteria |
Well matched |
Extended delays for IRB/site activation |
Activation/IRB approval at planned participating site |
Well matched |
High rate of screen failures |
Promotion of trial – internal |
Potential to influence |
Longer than expected pre-specified halt/change to enrollment due to interim analyses, stopping rules, data review by DMC |
Add new institutions |
Does not match |
Longer than expected pre-specified halt/change to enrollment due to interim analyses, stopping rules, data review by DMC |
No action provided |
Does not match |