a: Sample size re-estimation and enrichment design
b: Fisher exact test was conducted
c: Conditional marketing authorisation, Post-authorisation safety study, Post-authorisation efficacy study
Table 4 provides additional descriptive statistics by study progression. Overall, most studies were completed (24/41, 58.54%) before medicines were approved. Group sequential design dominated the majority of design types (9/17, 52.94%) in those drug were approved but ongoing studies continued. In cases in which the drug was approved and studies had been completed, the proportion of seamless design outweighed group sequential design and became the most popular design type (9/24, 37.50%). Compared with the group of products approved with completed studies, the proportion of orphan drugs (8/17, 47.06%) was largely greater. When comparing the 2 groups of different study progression, there was a statistically significant difference in the proportion of antitumor drugs (P value = 0.0001) as well as those that required CMA, PASS, or PAES (P value = 0.0230).
Table 4. Overview of the study status of approvals