Table 3.

Features of clinical trials leading to oncologic drug approvals.

Characteristic	Item	Number	Percentage (%)
Phase	I	3	2
	I–II	9	7
	II	21	16
	II–III	2	2
	III	97	73
Hypothesis	Superiority	100	76
	Non-inferiority	6	5
	Superiority and non-inferiority	2	1
	Exploratory/descriptive/NA	24	18
Mean sample size (range)	-	603.5 (12–4805)	-
Randomization	Yes	109	82
	No	23	18
Control arm	Active treatment with PL	24	18
	Active treatment without PL	62	47
	PL/BSC	23	17.5
	No control arm	23	17.5
Experimental arm	Monotherapy	77	58
	Combo	55	42
Crossover	Yes	15	11
	No	117	89
Primary Endpoint
Advanced disease	OS	51	42
	PFS	42	35
	ORR	26	22
	Other outcomes	1	1
Non advanced	OS	1	8
	Other survival outcomes	9	75
	PK/pCR	2	17
Quality of life
Evaluated by trial	Yes	107	81
	No	25	19
Reported in EPAR	Yes	88	67
	No	44	33
Descriptive	No difference between EX and CT arm	55	42
	In favor of EX arm	21	16
	In favor of CT arm	3	2
	Not applicable	53	40

PL: placebo; EX: experimental; CT: control.