Table 1.
Factors associated with time to reporting (TTR) from enrollment completion and initiation. Univariate and multiple regression model.
| Factor | No. (%) | Median TTR from Enrollment Completion in Months | Univariate p-Value * | Multiple Regression p-Value | Median TTR from Enrollment Initiation in Months | Univariate p-Value * | Multiple Regression p-Value | |
|---|---|---|---|---|---|---|---|---|
| Overall | 319 | 31.0 (IQR: 22.0–41.0) | - | 60.0 (IQR: 47.0–77.0) | - | |||
| Cooperative-group-sponsorship | No | 259 (81.2) | 31.0 | <0.001 | 0.18 | 56.0 | <0.001 | 0.001 |
| Yes | 60 (18.8) | 37.5 | 81.5 | |||||
| Industry sponsorship | No | 32 (10.0) | 40.0 | 0.005 | 0.006 | 88.5 | <0.001 | <0.001 |
| Yes | 287 (90.0) | 31.0 | 58.0 | |||||
| Trial success ‖ | No | 143 (44.8) | 36.0 | <0.001 | <0.001 | 70.0 | <0.001 | <0.001 |
| Yes | 176 (55.2) | 27.5 | 52.0 | |||||
| Treatment modality ‡ | Chemotherapy | 167 (52.4) | 31.0 | 0.86 | 60.0 | 0.09 | ||
| Targeted therapy | 110 (34.5) | 32.0 | 59.0 | |||||
| Supportive care | 40 (12.5) | 29.0 | 64.0 | |||||
| Radiation therapy | 2 (0.6) | 25.0 | 119.5 | |||||
| Line of therapy | First-line | 155 (55.2) | 33.0 | 0.001 | 0.04 | 63.0 | <0.001 | 0.03 |
| Second-line or later | 126 (44.8) | 28.0 | 53.0 | |||||
| Disease site | Breast | 53 (16.6) | 35.0 | 0.45 | 68.0 | 0.20 | ||
| Genitourinary | 44 (13.8) | 26.5 | 59.0 | |||||
| Gastrointestinal | 64 (20.1) | 31.5 | 58.5 | |||||
| Thoracic | 77 (24.1) | 31.0 | 55.0 | |||||
| Other § | 81 (25.4) | 31.0 | 63.0 | |||||
| Enrollment region | Multinational | 260 (81.5) | 31.0 | 0.30 | 58.0 | 0.001 | 0.003 | |
| USA-only | 38 (11.9) | 32.0 | 77.5 | |||||
| Non-USA single country | 21 (6.6) | 33.0 | 69.0 | |||||
| Primary endpoint ^ | Nonsurrogate | 124 (44.4) | 32.5 | 0.03 | 0.53 | 63.0 | 0.003 | 0.12 |
| Surrogate | 155 (55.6) | 30.0 | 54.0 | |||||
| Study design | Noninferiority | 262 (86.7) | 31.0 | 0.41 | 59.5 | 0.07 | ||
| Superiority | 37 (12.4) | 32.0 | 65.0 | |||||
* Univariate analysis performed with Mann–Whitney U-tests (by cooperative-group-sponsorship, industry-sponsorship, trial success, primary endpoint, line of therapy, and study design) and Kruskal–Wallis tests (by treatment modality, disease site, and enrollment region). ‖ Trial success refers to trials where the primary endpoint was met. ‡ Treatment modality refers to the primary intervention as part of trial randomization. Chemotherapy generally includes cytotoxic agents, whereas targeted therapy includes monoclonal antibodies, small-molecule inhibitors, and similar. § Other disease site trials include single-disease site trials of head and neck, gynecologic, and skin malignancies, as well as trials allowing multiple disease sites. ^ Primary endpoint divided into nonsurrogate and surrogate endpoints; nonsurrogate endpoints include direct measures of quantity or quality of life (such as overall survival), or direct disease-related outcomes (such as disease-free survival). Surrogate endpoints include radiographic or pathologic endpoints (primarily progression-free survival and pathology or radiographic response rates).