Accounting for Carryover Toxicity in Phase I Clinical Trials with Intra‐Patient Dose Escalation
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| Format: | Artículo Open Access |
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2025
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| _version_ | 1867021426511314944 |
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| author | Chloe E. Falke Joseph S. Koopmeiners |
| author_facet | Chloe E. Falke Joseph S. Koopmeiners Chloe E. Falke Joseph S. Koopmeiners |
| collection | Wiley Open Access |
| contents | Accounting for Carryover Toxicity in Phase I Clinical Trials with Intra‐Patient Dose Escalation Chloe E. Falke Joseph S. Koopmeiners Statistics in Medicine ABSTRACTIntra‐patient dose escalation (IPDE) provides a strategy for more efficient Phase I clinical trials. However, IPDE poses additional challenges due to the need to account for carryover toxicity from previous dosings a patient has received. To that end, we propose two CRM–based approaches to IPDE that incorporate potential carryover toxicity. We compare these methods to the CRM without IPDE and the AIDE‐CRM, an existing Bayesian adaptive approach to IPDE. In simulations across a range of scenarios, we show that our approaches have similar operating characteristics to the CRM without IPDE, but with a 20% reduction in time and participants needed to complete the trial; these results hold even in the presence of strong carryover toxicity that hinders the performance of the AIDE‐CRM. 10.1002/sim.70059 http://creativecommons.org/licenses/by-nc/4.0/ |
| doi_str_mv | 10.1002/sim.70059 |
| format | Artículo Open Access |
| id | wiley_oa_10_1002_sim_70059 |
| institution | Wiley Open Access |
| license_str_mv | http://creativecommons.org/licenses/by-nc/4.0/ |
| publishDate | 2025 |
| publisher | Wiley |
| record_format | wiley_oa |
| spellingShingle | Accounting for Carryover Toxicity in Phase I Clinical Trials with Intra‐Patient Dose Escalation Chloe E. Falke Joseph S. Koopmeiners Statistics in Medicine Accounting for Carryover Toxicity in Phase I Clinical Trials with Intra‐Patient Dose Escalation Chloe E. Falke Joseph S. Koopmeiners Statistics in Medicine ABSTRACTIntra‐patient dose escalation (IPDE) provides a strategy for more efficient Phase I clinical trials. However, IPDE poses additional challenges due to the need to account for carryover toxicity from previous dosings a patient has received. To that end, we propose two CRM–based approaches to IPDE that incorporate potential carryover toxicity. We compare these methods to the CRM without IPDE and the AIDE‐CRM, an existing Bayesian adaptive approach to IPDE. In simulations across a range of scenarios, we show that our approaches have similar operating characteristics to the CRM without IPDE, but with a 20% reduction in time and participants needed to complete the trial; these results hold even in the presence of strong carryover toxicity that hinders the performance of the AIDE‐CRM. 10.1002/sim.70059 http://creativecommons.org/licenses/by-nc/4.0/ |
| title | Accounting for Carryover Toxicity in Phase I Clinical Trials with Intra‐Patient Dose Escalation |
| topic | Statistics in Medicine |
| url | https://onlinelibrary.wiley.com/doi/10.1002/sim.70059 |