Type of biopsy and biomarkers characteristics among studies requiring tissue and studies requiring at least one new biopsy
| Characteristics . | Studies requiring tissue (n = 119) . | Studies requiring new biopsies (n = 59) . |
|---|---|---|
| Archival tissue | ||
| Mandatory | 57 (48) | 13 (22) |
| Optional | 62 (52) | 46 (78) |
| New biopsy | ||
| No | 60 (51) | 0 (0) |
| 1 | 34 (29) | 34 (58) |
| 2 | 23 (19) | 23 (39) |
| >3 | 2 (1) | 2 (3) |
| Timing of new biopsy | ||
| At screening | 0 | 43 (73) |
| Per treatment | 0 | 33 (56) |
| At progression | 0 | 7 (12) |
| Type of biomarkers | ||
| Integral: necessary for inclusion | 35 (29) | 14 (24) |
| Integral: necessary for primary objective | 17 (15) | 5 (8) |
| Nonintegral: necessary for secondary objective | 5 (4) | 4 (7) |
| Nonintegral: necessary for exploratory objective | 62 (52) | 36 (61) |
| Utility | ||
| Expected utility: necessary for inclusion or primary objective | 63 (53) | 36 (61) |
| Potential utility | 12 (10) | 8 (14) |
| Unknown utility | 44 (37) | 15 (25) |
| Participant risk | ||
| Low risk | 4 (3) | 4 (7) |
| High or moderate risk | 11 (9) | 7 (12) |
| Undetermined | 104 (88) | 48 (81) |
| Adherence with the ASCO Ethical Framework | 80 (67) | 23 (39) |
| Characteristics . | Studies requiring tissue (n = 119) . | Studies requiring new biopsies (n = 59) . |
|---|---|---|
| Archival tissue | ||
| Mandatory | 57 (48) | 13 (22) |
| Optional | 62 (52) | 46 (78) |
| New biopsy | ||
| No | 60 (51) | 0 (0) |
| 1 | 34 (29) | 34 (58) |
| 2 | 23 (19) | 23 (39) |
| >3 | 2 (1) | 2 (3) |
| Timing of new biopsy | ||
| At screening | 0 | 43 (73) |
| Per treatment | 0 | 33 (56) |
| At progression | 0 | 7 (12) |
| Type of biomarkers | ||
| Integral: necessary for inclusion | 35 (29) | 14 (24) |
| Integral: necessary for primary objective | 17 (15) | 5 (8) |
| Nonintegral: necessary for secondary objective | 5 (4) | 4 (7) |
| Nonintegral: necessary for exploratory objective | 62 (52) | 36 (61) |
| Utility | ||
| Expected utility: necessary for inclusion or primary objective | 63 (53) | 36 (61) |
| Potential utility | 12 (10) | 8 (14) |
| Unknown utility | 44 (37) | 15 (25) |
| Participant risk | ||
| Low risk | 4 (3) | 4 (7) |
| High or moderate risk | 11 (9) | 7 (12) |
| Undetermined | 104 (88) | 48 (81) |
| Adherence with the ASCO Ethical Framework | 80 (67) | 23 (39) |
Data are shown as n (%)
Abbreviation: ASCO, American Society of Clinical Oncology.
Type of biopsy and biomarkers characteristics among studies requiring tissue and studies requiring at least one new biopsy
| Characteristics . | Studies requiring tissue (n = 119) . | Studies requiring new biopsies (n = 59) . |
|---|---|---|
| Archival tissue | ||
| Mandatory | 57 (48) | 13 (22) |
| Optional | 62 (52) | 46 (78) |
| New biopsy | ||
| No | 60 (51) | 0 (0) |
| 1 | 34 (29) | 34 (58) |
| 2 | 23 (19) | 23 (39) |
| >3 | 2 (1) | 2 (3) |
| Timing of new biopsy | ||
| At screening | 0 | 43 (73) |
| Per treatment | 0 | 33 (56) |
| At progression | 0 | 7 (12) |
| Type of biomarkers | ||
| Integral: necessary for inclusion | 35 (29) | 14 (24) |
| Integral: necessary for primary objective | 17 (15) | 5 (8) |
| Nonintegral: necessary for secondary objective | 5 (4) | 4 (7) |
| Nonintegral: necessary for exploratory objective | 62 (52) | 36 (61) |
| Utility | ||
| Expected utility: necessary for inclusion or primary objective | 63 (53) | 36 (61) |
| Potential utility | 12 (10) | 8 (14) |
| Unknown utility | 44 (37) | 15 (25) |
| Participant risk | ||
| Low risk | 4 (3) | 4 (7) |
| High or moderate risk | 11 (9) | 7 (12) |
| Undetermined | 104 (88) | 48 (81) |
| Adherence with the ASCO Ethical Framework | 80 (67) | 23 (39) |
| Characteristics . | Studies requiring tissue (n = 119) . | Studies requiring new biopsies (n = 59) . |
|---|---|---|
| Archival tissue | ||
| Mandatory | 57 (48) | 13 (22) |
| Optional | 62 (52) | 46 (78) |
| New biopsy | ||
| No | 60 (51) | 0 (0) |
| 1 | 34 (29) | 34 (58) |
| 2 | 23 (19) | 23 (39) |
| >3 | 2 (1) | 2 (3) |
| Timing of new biopsy | ||
| At screening | 0 | 43 (73) |
| Per treatment | 0 | 33 (56) |
| At progression | 0 | 7 (12) |
| Type of biomarkers | ||
| Integral: necessary for inclusion | 35 (29) | 14 (24) |
| Integral: necessary for primary objective | 17 (15) | 5 (8) |
| Nonintegral: necessary for secondary objective | 5 (4) | 4 (7) |
| Nonintegral: necessary for exploratory objective | 62 (52) | 36 (61) |
| Utility | ||
| Expected utility: necessary for inclusion or primary objective | 63 (53) | 36 (61) |
| Potential utility | 12 (10) | 8 (14) |
| Unknown utility | 44 (37) | 15 (25) |
| Participant risk | ||
| Low risk | 4 (3) | 4 (7) |
| High or moderate risk | 11 (9) | 7 (12) |
| Undetermined | 104 (88) | 48 (81) |
| Adherence with the ASCO Ethical Framework | 80 (67) | 23 (39) |
Data are shown as n (%)
Abbreviation: ASCO, American Society of Clinical Oncology.
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