Table 1.
Characteristics of eligible early phase dose-finding oncology trials.
| Overall (N = 35) | |
|---|---|
| Trial design | |
| Algorithmic | 22 (62.9%) |
| 3 + 3 | 16 (45.7%) |
| Rolling six | 4 (11.4%) |
| Other | 2 (5.7%) |
| Model based | 7 (20.0%) |
| Continual reassessment method (CRM) | 5 (14.3%) |
| Time-to-event continual reassessment method (TiTE-CRM) | 1 (2.9%) |
| Escalation with overdose control (EWOC) | 1 (2.9%) |
| Unclear | 6 (17.1%) |
| Intervention type | |
| Drug | 17 (48.6%) |
| Drug + radiotherapy | 5 (14.3%) |
| Radiotherapy | 13 (37.1%) |
| Number of PRO measures | |
| 1 | 15 (42.9%) |
| 2 | 11 (31.4%) |
| 3 | 8 (22.9%) |
| 5 | 1 (2.9%) |
| Number of PRO assessments | |
| Mean (SD) | 6.31 (4.75) |
| Median [min, max] | 5.00 [2.00, 24.0] |
| Type of PRO analysis | |
| Descriptive | 15 (42.9%) |
| Descriptive & inferential | 11 (31.4%) |
| Inferential | 9 (25.7%) |
| PRO endpoint | |
| Exploratory | 1 (2.9%) |
| Secondary | 23 (65.7%) |
| Tertiary | 1 (2.9%) |
| Unclear | 10 (28.6%) |
A full table presenting a summary of all extracted features is presented in Supplementary Table S2.