Table 1.
Decision boundaries | |||||
---|---|---|---|---|---|
Conclude objective is met and stop study early | Conclude that sample size is sufficient to continue | Determine that sample size is insufficient but elect not to increase sample size | Conclude that sample size must be increased in increments of 175 | Stop study for safety | |
First Interim Analysis | PRR > 0.9 | and | P () 0.90 | ||
Sample Size Re-estimation Phase | N/A | PRR > 0.9 | and | N/A | |
Second Interim Analysis | If neither the outcome in column 2 nor the outcome in column 6 occurs, then the study will continue with the current sample size. | P () 0.90 |
NOTE: See Curtis et al. (2013) for details.