Table 2 Overall classification of RCTs reporting interim analysis or DMC use based on trial progress
Trial Progress | Trials reporting interim analysis (with or without specification of a DMC) | Trials identified as having extended use of interim data or DMC recommendations | Trials identified as having extended use of interim data or DMC recommendations with the potential to introduce bias |
|---|---|---|---|
Total (N) | 586 | 74 | 28 |
Continued to or Extended beyond planned conclusion | 457 | 55 | 26 |
Early stop for benefit | 53 | 7 | 1 |
Early stop for harm | 22 | 3 | 0 |
Stopped for futility | 28 | 7 | 0 |
Early stop for other reasons | 26 | 2 | 1 |