ArticlemedRxiv : the preprint server for health sciences2025
A Proof-of-Concept Clinical Trial Design for Evolutionary Guided Precision Medicine for Cancer.
Article in medRxiv : the preprint server for health sciences, 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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Authors and funding
7 authors.
Funding
Abstract
Current Precision Medicine (CPM) matches cancer therapies to consensus molecular characteristics at one or more timepoints. However, cancers contain extensive subclonal heterogeneity leading to dynamic evolution in response to therapy. Mathematical modeling has the potential to optimize timing and sequencing of therapies in a more effective and personalized manner than CPM. Clinical trial designs testing Evolutionary Guided Precision Medicine (EGPM) strategies for preventing or delaying relapse to improve outcomes, are needed. In a simulation, we evaluated Dynamic Precision Medicine (DPM), an EGPM, in a stratified randomized design based on whether the patient was predicted to benefit from DPM, using an evolutionary classifier. We present this new proof-of-concept clinical trial design and perform simulations which show high power, control of false positive rates, and robust performance in the face of anticipated challenges to clinical translation. The design is distinct from common biomarker-driven designs and can provide a robust evaluation of EGPM.
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Registered trials
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