TABLE 4.
Minimal, mean, and maximal study durations (treatment plus recruitment) for Phase 1, Phase 2, and Phase 3 trials of DMT biologics, DMT small molecules, cognitive enhancing agents, and drugs for neuropsychiatric syndromes (prevention trials not included).
| Therapeutic purpose | Relative duration | Phase 1 | Phase 2 | Phase 3 | Total; weeks | Total; years |
|---|---|---|---|---|---|---|
| DMT; biologic | Minimal | 49.0 | 47.9 | 104.3 | 201.2 | 3.9 |
| Mean | 141.9 | 218.9 | 302.3 | 663.1 | 12.7 | |
| Maximal | 286.3 | 635.0 | 773.9 | 1695.2 | 32.5 | |
| DMT; small molecule | Minimal | 74.6 | 58.6 | 43.7 | 176.9 | 3.4 |
| Mean | 124.7 | 184.5 | 195.8 | 505.0 | 9.7 | |
| Maximal | 191.3 | 495.9 | 291.7 | 978.9 | 18.8 | |
| Cognitive enhancing agent | Minimal | 53.9 | 52.1 | 156.6 | 262.6 | 5 |
| Mean | 136.8 | 178.9 | 206.7 | 522.4 | 10 | |
| Maximal | 219.7 | 446.0 | 243.7 | 909.4 | 17.4 | |
| Drugs for NPS | Minimal | 191.9 | 52.3 | 79.0 | 323.2 | 6.2 |
| Mean | 194.3 | 165.6 | 219.5 | 579.4 | 11.1 | |
| Maximal | 196.7 | 378.3 | 500.0 | 1075.0 | 20.6 |
Abbreviations: DMT, Disease‐modifying therapy; NPS, neuropsychiatric symptoms.