Points to evaluate | Dabigatran | Ipilimumab | Gefitinib | Gefitinib* | Vilazodone | Latrepirdine | Semagacestat |
|---|
1 | 5 [4] | 3 [5] | 5 [6, 7] | 5 [6–10] | 3 [11] | - | 5 [12, 13] |
2 | 5 [4] | 1 [5] | 3 [6, 7, 14] | 4 [6, 7, 10, 14] | 1 [15] | - | 5 [12, 13] |
3 | 3 [16, 17] | 5 [5] | 3 [1] | 5 [1] | 1 | - | 3 [18, 19] |
4 | 3 [20, 21] | 2 [5] | 5 [1] | 5 [1, 10, 22] | 1 | - | 0 [23] |
5 | 1 | 5 [5] | 5 [24, 25] | 5 [8, 9] | 5 [26, 27] | - | 1 [23] |
6 | 10 [20, 21] | 4 [5] | 10 [24, 25] | 10 [8–10, 22, 28] | 6 [26, 27] | - | 0 [23] |
7 | 4 [29] | 5 [5] | 4 [30] | 5 [28, 30] | 1 | - | 1 [23] |
8 | 3 [31] | 4 | 4 | 5 | 1 [32] | - | 5 [33, 34] |
9 | 3 [35] | 4 | 4 | 5 | 1 [32] | - | 4 |
10 | 5 [36] | 5 [1, 5] | 5 [1] | 5 [1] | 5 [11] | - | 4 |
Sum
|
42
|
38
|
48
|
54
|
25
|
0
|
0
|
- *after the development of the pivotal biomarker (EGFR mutation status)
- The leading biomarkers evaluated were: aPTT for dabigatran, immune related response criteria for ipilimumab, effects on tumor growth for gefitinib, tumor growth and mutation status of EGFR for gefitinib, Hamilton Rating scale for depression-17 for vilazodone, none for latrepirdine, and effects on amyloid plaques for semagacestat.
- Points to evaluate:
- 1. Are animal or in vitro data available?
- 2. How many species have been tested positively?
- 3. Are the animal models enough to reflect human disease?
- 4. Is there corresponding clinical data?
- 5. Are human data available?
- 6. Human data classification (2x)
- 7. Does the biomarker represent a pivotal disease constituent?
- 8. What is the statistical predictability?
- 9. What is the accuracy or reproducibility of the assay?
- 10. How accessible is the specimen?
