Please use this identifier to cite or link to this item: http://hdl.handle.net/2445/138571
Title: Sex-Divergent Clinical Outcomes and Precision Medicine: An Important New Role for Institutional Review Boards and Research Ethics Committees
Author: Segarra Bañeres, Ignacio
Modamio Charles, Pilar
Fernández Lastra, Cecilia
Mariño Hernández, Eduardo L.
Keywords: Farmacocinètica
Bioètica
Diferències entre sexes
Pharmacokinetics
Bioethics
Sex differences
Issue Date: 2017
Publisher: Frontiers Media
Abstract: The efforts toward individualized medicine have constantly increased in an attempt to improve treatment options. These efforts have led to the development of small molecules which target specific molecular pathways involved in cancer progression. We have reviewed preclinical studies of sunitinib that incorporate sex as a covariate to explore possible sex-based differences in pharmacokinetics and drug-drug interactions (DDI) to attempt a relationship with published clinical outputs. We observed that covariate sex is lacking in most clinical outcome reports and suggest a series of ethic-based proposals to improve research activities and identify relevant different sex outcomes. We propose a deeper integration of preclinical, clinical, and translational research addressing statistical and clinical significance jointly; to embed specific sexdivergent endpoints to evaluate possible gender differences objectively during all stages of research; to pay greater attention to sex-divergent outcomes in polypharmacy scenarios, DDI and bioequivalence studies; the clear reporting of preclinical and clinical findings regarding sex-divergent outcomes; as well as to encourage the active role of scientists and the pharmaceutical industry to foster a new scientific culture through their research programs, practice, and participation in editorial boards and Institutional Ethics Review Boards (IRBs) and Research Ethics Committees (RECs). We establish the IRB/REC as the centerpiece for the implementation of these proposals. We suggest the expansion of its competence to follow up clinical trials to ensure that sex differences are addressed and recognized; to engage in data monitoring committees to improve clinical research cooperation and ethically address those potential clinical outcome differences between male and female patients to analyze their social and clinical implications in research and healthcare policies. Keywords: sunitinib, sex-divergent pharmacokinetics, clinical outcomes, covariate sex, research ethics, IRB, ELSI
Note: Reproducció del document publicat a: https://doi.org/10.3389/fphar.2017.00488
It is part of: Frontiers in Pharmacology, 2017, vol. 8, p. 488
URI: http://hdl.handle.net/2445/138571
Related resource: https://doi.org/10.3389/fphar.2017.00488
ISSN: 1663-9812
Appears in Collections:Articles publicats en revistes (Farmàcia, Tecnologia Farmacèutica i Fisicoquímica)

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