Association of differential censoring with survival and suboptimal control arms among oncology clinical trials
© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissionsoup.com..
Differential censoring (DC), referring to censoring imbalance between treatment arms, may bias the interpretation of survival outcomes in clinical trials. In 146 phase 3 oncology trials with statistically significant time-to-event surrogate primary endpoints (PEPs), we evaluated the association between DC in the surrogate PEP, control arm adequacy, and the subsequent statistical significance of OS results. Twenty-four (16%) trials exhibited DC favoring the control arm (ConDC), while 15 (10%) exhibited experimental arm DC (ExpDC). Positive OS was more common in ConDC trials (63%) than trials without DC (37%) or with ExpDC (47%; odds ratio [OR] 2.64, 95% CI 1.10-7.20; P=.04). ConDC trials more frequently used suboptimal control arms (46%) compared to 20% without DC and 13% with ExpDC (OR 3.60, 95% CI 1.29-10.0; P=.007). The presence of ConDC in trials with surrogate PEPs, especially in those with OS conversion, may indicate an inadequate control arm and should be examined and explained.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
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| Enthalten in: |
Journal of the National Cancer Institute - (2024) vom: 09. Feb. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Hsu, Eric J [VerfasserIn] |
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Date Revised 08.02.2024 published: Print-Electronic Citation Status Publisher |
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| doi: |
10.1093/jnci/djae028 |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM368208818 |
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| 245 | 1 | 0 | |a Association of differential censoring with survival and suboptimal control arms among oncology clinical trials |
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| 520 | |a © The Author(s) 2024. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissionsoup.com. | ||
| 520 | |a Differential censoring (DC), referring to censoring imbalance between treatment arms, may bias the interpretation of survival outcomes in clinical trials. In 146 phase 3 oncology trials with statistically significant time-to-event surrogate primary endpoints (PEPs), we evaluated the association between DC in the surrogate PEP, control arm adequacy, and the subsequent statistical significance of OS results. Twenty-four (16%) trials exhibited DC favoring the control arm (ConDC), while 15 (10%) exhibited experimental arm DC (ExpDC). Positive OS was more common in ConDC trials (63%) than trials without DC (37%) or with ExpDC (47%; odds ratio [OR] 2.64, 95% CI 1.10-7.20; P=.04). ConDC trials more frequently used suboptimal control arms (46%) compared to 20% without DC and 13% with ExpDC (OR 3.60, 95% CI 1.29-10.0; P=.007). The presence of ConDC in trials with surrogate PEPs, especially in those with OS conversion, may indicate an inadequate control arm and should be examined and explained | ||
| 650 | 4 | |a Journal Article | |
| 700 | 1 | |a Lin, Timothy A |e verfasserin |4 aut | |
| 700 | 1 | |a Dabush, Dor R |e verfasserin |4 aut | |
| 700 | 1 | |a McCaw, Zachary |e verfasserin |4 aut | |
| 700 | 1 | |a Koong, Alex |e verfasserin |4 aut | |
| 700 | 1 | |a Lin, Christine |e verfasserin |4 aut | |
| 700 | 1 | |a Abi Jaoude, Joseph |e verfasserin |4 aut | |
| 700 | 1 | |a Patel, Roshal |e verfasserin |4 aut | |
| 700 | 1 | |a Kouzy, Ramez |e verfasserin |4 aut | |
| 700 | 1 | |a El Alam, Molly B |e verfasserin |4 aut | |
| 700 | 1 | |a Noticewala, Sonal |e verfasserin |4 aut | |
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