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Sex as a biological variable in early-phase oncology clinical trials: enhancing the path to personalised medicine

Sutherland, Lydia
; 
Carter, Louise
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Abstract
Sex is an essential biological variable that influences the development, progression and response to treatment in cancer. Despite this, early-phase cancer clinical trials frequently neglect to consider sex as a variable, creating a barrier to the development of personalised medicine. This article argues that failure to identify and infer sex differences in early-phase clinical trials may result in suboptimal dosing, underestimation of toxicity, and the failure to identify potential sex-specific responses to new systemic anticancer therapies. There should be a greater focus on sex as a biological variable in drug development so that thoughtful and deliberate study design can bring precision to the development of new systemic cancer therapies.
Authors
Sutherland, Lydia
Carter, Louise
Affiliation
Division of Cancer Sciences, School of Medical Sciences, University of Manchester, Manchester, UK Department of Pharmacy, The Christie NHS Foundation Trust, Manchester, UK Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK
Description
Date
2024
Publisher
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All Christie Publications
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Type
Article
Citation
Sutherland L, Carter L. Sex as a Biological Variable in Early-Phase Oncology Clinical Trials: Enhancing the Path to Personalised Medicine. Heliyon. 2024 JUN 30;10(12).
Journal Title
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Volume Title
URI
http://hdl.handle.net/10541/627120
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