Table 1.
Study Characteristics | ICT Trials (n=221) |
---|---|
Trial phase designation | |
Phase I | 173 (78%) |
Phase I–II | 23 (10%) |
Phase II | 21 (10%) |
Phase III | 4 (2%) |
Trial source | |
Non-Industry externally funded* | 8 (4%) |
Industry | 133 (60%) |
Institution | 77 (35%) |
National cooperative group | 3 (1%) |
Trial timeframes: median (IQR), months | |
Submission to activation | 4.3 (3.0–6.0) |
Submission to IRB approval | 1.2 (1.0–1.8) |
IRB approval to activation | 2.6 (1.6–4.4) |
Activation to first patient enrolled** | 0.4 (0.1–1.1) |
Trial accrual: median (IQR) | |
Accrual rate: participants/year | 15.3 (9.6–26.1) |
Total accrual: participants | 30 (12–57) |
Trials activated per investigator: median (range) | 16 (6–45) |
Abbreviations: ICT, investigational cancer therapeutics; IRB, Institutional Review Board; IQR, interquartile range
Funding sources include: National Institutes of Health [NIH], Department of Defense [DoD], National Cancer Institute [NCI], and Cancer Therapy Evaluation Program [CTEP].
Includes only trials that accrued at least one participant.