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| No. | % | |
|---|---|---|
| Phase III RCT | 14 | 52 |
| NC-RCT | 4 | 14 |
| SAT | 8 | 30 |
| Otherb | 1 | 4 |
RCT=randomised clinical trial; SAT=single-arm trial; NC-RCT=noncomparative RCT.
In at least two cases (docetaxel and doxorubicin pegylated), further comparative RCT were carried out to support preliminary findings.
Approval without empirical data, supported by bibliographic review of nonclinical and clinical data.
