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

Table 3.

Scientific design characteristics by TA and indication (Phase II and III only)

Means (Coefficients of Variation) Oncology Non-oncology Rare diseases Non-rare diseases
Total Endpoints 15.3 (0.49) 21.4 (0.58) 12.9 (0.46) 21.2 (0.56)
Total Eligibility Criteria 29.8 (0.33) 31.0 (0.37) 28.9 (0.38) 31.1 (0.36)
Number of Distinct Procedures 33.3 (0.45) 34.3 (0.32) 38.1 (0.50) 33.3 (0.32)
Total Procedures Performed 315.0 (0.93) 243.0 (1.09) 301.6 (1.14) 255.6 (1.02)
Non-Core Procedures (% of Total) 24.1% (0.82) 24.9% (0.74) 14.0% (0.83) 26.4% (0.72)
Total Protocol Pages 125.2 (0.23) 107.5 (0.39) 115.3 (0.18) 110.8 (0.39)
Total Case Report Form Pages 175.8 (0.84) 168.7 (0.84) 244.0 (0.74) 158.7 (0.83)
Total Datapoints Collected 2,563,973 (2.13) 2,732,132 (1.60) 1,599,282 (2.69) 2,908,916 (1.59)
Total Data Sources 3.9 (0.45) 4.2 (0.37) 4.2 (0.33) 4.1 (0.41)