|
Drug approved with ongoing studyb
(n = 17)
|
Drug approved with completed studyc
(n = 24)
|
Total
(n = 41)
|
P valued
|
Pivotal trial, n(%) |
|
|
|
0.7113 |
Yes |
14 (82.35) |
18 (75.00) |
32 (78.05) |
|
No |
3 (17.65) |
6 (25.00) |
9 (21.95) |
|
Design types, n(%) |
|
|
|
0.1932 |
Seamless design |
6 (35.29) |
9 (37.50) |
15 (36.59) |
|
Group sequential |
9 (52.94) |
8 (33.33) |
17 (41.46) |
|
Sample size re-estimation |
1 (5.88) |
0 (0.00) |
1 (2.44) |
|
Combined groupa
|
0 (0.00) |
1 (4.17) |
1 (2.44) |
|
Adaptations to treatment arm selection |
0 (0.00) |
1 (4.17) |
1 (2.44) |
|
Adaptive dose-ranging |
0 (0.00) |
1 (4.17) |
1 (2.44) |
|
Basket study |
1 (5.88) |
0 (0.00) |
1 (2.44) |
|
Enrichment design |
0 (0.00) |
4 (16.67) |
4 (9.76) |
|
Orphan drug, n(%) |
|
|
|
0.1887 |
Yes |
8 (47.06) |
6 (25.00) |
14 (34.15) |
|
No |
9 (52.94) |
18 (75.00) |
27 (65.85) |
|
Antitumor drug, n(%) |
|
|
|
0.0001 |
Yes |
14 (82.35) |
5 (20.83) |
19 (46.34) |
|
No |
3 (17.65) |
19 (79.17) |
22 (53.66) |
|
Accelerated assessment, n(%) |
|
|
|
1.0000 |
Yes |
1 (5.88) |
2 (8.33) |
3 (7.32) |
|
No |
16 (94.12) |
22 (91.67) |
38 (92.68) |
|
New active substance, n(%) |
|
|
|
0.2623 |
Yes |
15 (88.24) |
17 (70.83) |
32 (78.05) |
|
No |
2 (11.76) |
7 (29.17) |
9 (21.95) |
|
Additional monitoring, n(%) |
|
|
|
0.1120 |
Yes |
12 (70.59) |
10 (41.67) |
22 (53.66) |
|
No |
5 (29.41) |
14 (58.33) |
19 (46.34) |
|
CMA, PASS, PAES n(%)e |
|
|
|
0.0230 |
Yes |
11 (64.71) |
6 (25.00) |
17 (41.46) |
|
No |
6 (35.29) |
18 (75.00) |
24 (58.54) |
|
System organ class of indications, n(%) |
|
|
|
0.1201 |
Nervous system disorders |
0 (0.00) |
1 (4.17) |
1 (2.44) |
|
Congenital, familial, and genetic disorders |
1 (5.88) |
1 (4.17) |
2
(4.88) |
|
Renal and urinary disorder |
1 (5.88) |
1 (4.17) |
2 (4.88) |
|
Respiratory, thoracic, and mediastinal disorders |
1 (5.88) |
3 (12.50) |
4 (9.76) |
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
6
(35.29) |
1 (4.17) |
7 (18.92) |
|
Blood and lymphatic system disorders |
5 (29.41) |
3 (12.50) |
8 (19.51) |
|
Gastrointestinal disorders |
1 (5.88) |
3 (12.50) |
4 (8.11) |
|
Skin and subcutaneous tissue disorders |
0 (0.00) |
3 (12.50) |
3 (7.32) |
|
Immune system disorders |
0 (0.00) |
2 (8.33) |
2 (4.88) |
|
Vascular disorders |
0 (0.00) |
2 (8.33) |
2 (4.88) |
|
Metabolism and nutrition disorders |
0 (0.00) |
1 (4.17) |
1 (2.44) |
|
Cardiac disorders |
0 (0.00) |
1 (4.17) |
1 (2.44) |
|
Infections and infestations |
2 (11.76) |
0 (0.00) |
2 (4.88) |
|
Psychiatric disorders |
0 (0.00) |
1 (4.17) |
1 (2.44) |
|
Musculoskeletal and connective tissue disorders |
0 (0.00) |
1 (4.17) |
1 (2.44) |
|