ArticleStatistics in medicine2025
Accounting for Carryover Toxicity in Phase I Clinical Trials with Intra-Patient Dose Escalation.
Article in Statistics in medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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2 authors.
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Abstract
Intra-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.
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