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. 2022 Apr 4;56(4):632–636. doi: 10.1007/s43441-022-00401-4

Table 3.

Mean total number of protocol deviations per protocol by major disease category

Combined phase II/III protocols (n = 139) Oncology Non-oncology Rare disease indications Non-rare disease indications
Mean number of protocol deviations 108.8 91.9 78.1 98.7
Proportion of patients with protocol deviations (%) 46.6% 27.4% 27.7% 32.1%