Table 5.
CSSEC discussion issues and impact on proposal outcome.
| CSSEC Discussion Issue | Times Discussed | Times Affected Approval Decision |
|---|---|---|
| Design, including randomization and stratification | 27 | 6 |
| Primary endpoints/outcome measures | 26 | 10 |
| Secondary endpoints | 19 | 0 |
| Assumptions about event rate/effect size | 17 | 4 |
| Assumptions about subject recruitment | 17 | 2 |
| Study importance/generalizability | 16 | 6 |
| Site execution/event adjudication | 15 | 1 |
| Safety and adverse event reporting | 14 | 2 |
| Inclusion/exclusion criteria | 12 | 1 |
| Length of follow-up | 9 | 1 |
| Drug dosing | 9 | 1 |
| Blinding | 9 | 0 |
| Bias | 9 | 0 |
| Power analysis | 6 | 3 |
| Missing data | 6 | 1 |
| Will results be made obsolete by practice changes? | 6 | 0 |
| Cost-effectiveness analyses | 2 | 1 |