Table 1 Characteristics of the NI trials
From: Phase IV non-inferiority trials and additional claims of benefit
| Â | N (%) |
|---|---|
| Â | (Unless stated otherwise) |
I. Type of Drugs | Â |
 Anti-infective | 9 (22) |
 Cardiovascular system | 9 (22) |
 Systemic hormonal preparations | 5 (12) |
 Vaccines | 5 (12) |
 Musculo-skeletal system | 2 (5) |
 Nervous system | 3 (7) |
 Antineoplastic | 2 (5) |
 Others | 6 (15) |
II. Type of trial initiators | Â |
 Non-pharmaceutical industry | 12 (29) |
 Pharmaceutical industry | 25 (61) |
 Not clear | 4 (10) |
III. Number of trial subjects (median (interquartile range)) | 316 (196–629) |
IV. Type of analysis | Â |
 Both ITT and PP | 19 (46) |
 ITT only | 13 (32) |
 PP only | 8 (20)_ |
 Unclear | 1 (2) |
V. Conclusion of the trial | Â |
 Non-inferiority | 30 (73) |
 Superiority | 2 (5) |
 Inferiority | 6 (15) |
 Others | 3 (7) |
VI. Mentioned additional benefit | 22 (54) |