Table 2. Evaluation of anticancer drugs by EMEA from 1995 to 2004: summary of the 48 studies used as basis for approval.
Clinical trial design (48 trials) | Type of end point (primary) (48 trials) | Difference in survival, when available (13 trials) |
---|---|---|
RCT 25 | Survival 4 | Range 0–3.7 months |
SAT 19 | Resp. rate 30 | Mean 1.5 (months) |
NC-RCT 4 | TTP/PFS 14 | Median 1.2 (months) |
RCT=randomised clinical trial; SAT=single-arm trial; NC-RCT=noncomparative RCT; TTP=time to progression; PFS=progression-free survival.