Table 1.
Characteristics Used to Differentiate Trials of Hypothetical New Drugs, According to Methodologic Rigor.
| Characteristic | Level of Rigor | ||
|---|---|---|---|
| High | Medium | Low | |
| Randomization | Randomized | Randomized | Randomized |
| Blinding | Double-blind | Single-blind | Open-label |
| Comparator | Active | Active | Usual care |
| Dropout rate (%) | <9 | 13 | 19 |
| Sample size (no. of patients) | 5322 | 964 | 483 |
| End point | Mortality | Surrogate | Surrogate |
| Patient population | Representative | Representative | Not representative |
| Length of follow-up (mo) | 36 | 12 | 4 |
| Report of safety | Drug appears to be safe | Drug appears to be safe | No report |