Table 1.

Summary statistics for CTEP-sponsored phase I, I/II, II, and III trials

Phase I (n = 143)Phase I/II (n = 36)Phase II (n = 192)Phase III (n = 48)Total (n = 419)
Trial characteristics
    Minimum projected accrual (median, IQR)18 (9-25)20 (12.3-35)21 (16-34)638 (402-1,323)21 (15-38)
    Development time, mo (median, IQR)13.5 (10.9-18.0)13.9 (11.0-17.6)13.9 (11.5-17.3)17.9 (14.2-23.8)14.2 (11.3-18.5)
All trials1433619248419
    Attainment of accrual goal*103 (72.0%)20 (55.6%)123 (64.1%)14 (29.2%)260 (62.1%)
        Development time, mo (median, IQR)12.9 (10.5-17.9)11.5 (9.0-14.8)13.0 (11.1-15.8)17.8 (11.7-19.8)13.1 (10.9-17.3)
    Nonattainment of accrual goal*40 (28.0%)16 (44.4%)69 (35.9%)34 (70.8%)159 (37.9%)
        Development time, mo (median, IQR)15.8 (12.2-20.2)14.8 (12.5-18.5)15.0 (12.2-19.1)18.1 (15.2-26.9)15.8 (10.9-17.3)
Trial closed to accrual98 (68.5%)30 (83.3%)151 (78.6%)29 (60.4%)308 (73.5%)
    Attainment of accrual goal (no. of trials with ≥100% of accrual goal)65 (66.3%)16 (53.3%)96 (63.6%)11 (37.9%)188
    Nonattainment of accrual goal (no. of trials with <100% of accrual goal)33 (33.7%)14 (46.7%)55 (36.4%)18 (62.1%)120
    Accrual period, mo (median, IQR)38 (28-52)31 (25-49)32 (22-41)32 (23-39)33 (23-47)
Trials open to accrual45 (31.5%)6 (16.7%)41 (21.4%)19 (39.6%)111 (26.5%)
    Attainment of accrual goal (no. of trials with ≥75% of accrual goal)38 (84.4%)4 (66.7%)27 (65.9%)3 (15.8%)72
    Nonattainment of accrual goal (no. of trials with ≥75% of accrual goal)7 (15.6%)2 (33.3%)14 (34.1%)16 (84.2%)39
    Accrual period, mo (median, IQR)50 (39 63)54 (40-61)45 (40-56)52 (43-60)47 (41-58)
  • *Success and failure of a study is defined by the accrual performance of studies closed to accrual and studies that are opened to accrual at the time of sampling.

  • Accrual period for studies opened to accrual reflects the time that the study was opened at the time of study sampling. Actual accrual periods may be longer than observed.