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. 2022 Aug 12;57(1):49–56. doi: 10.1007/s43441-022-00438-5

Table 7.

Select protocol performance outcome comparisons (phase II and III combined)

Mean Duration Days and Mean Percents Oncology Non-Oncology Rare Diseases Non-Rare
Diseases
Total Clinical Trial Duration (Final Protocol to DBL) 1,598.7 1,080.9 1,304.8 1,147.4
Study Initiation Duration (Final Protocol to FPFV) 148.4 146.4 173.3 141.2
Enrollment Duration (FPFV-LPFV) 575.2 436.8 603.2 444.2
Study Conduct Duration (LPFV-LPLV) 659.4 334.7 384.1 384.8
Treatment Duration (FPFV-LPLV) 1,327.2 852.0 1,073.6 905.9
Study Close-Out Duration (LPLV-DBL) 68.5 59.9 61.4 61.4
Time to Clinical Report (DBL-CSR) 186.7 154.1 142.5 161.8
Randomization Rate 67.1% 70.9% 76.3% 68.9%
Completion Rate 31.4% 80.0% 50.8% 72.5%