Show simple item record

dc.contributor.authorSegarra, Ignacio
dc.contributor.authorModamio, Pilar
dc.contributor.authorFernandez, Cecilia
dc.contributor.authorMariño, Eduardo
dc.date.accessioned2019-09-10T10:59:32Z
dc.date.available2019-09-10T10:59:32Z
dc.date.issued2017-07-21
dc.identifier.citationSegarra I, Modamio P, Fernández C and Mariño EL (2017) Sex-Divergent Clinical Outcomes and Precision Medicine: An Important New Role for Institutional Review Boards and Research Ethics Committees. Front. Pharmacol. 8:488. doi: 10.3389/fphar.2017.00488es
dc.identifier.urihttp://hdl.handle.net/10952/4060
dc.description.abstractThe 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 sex-divergent 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.es
dc.language.isoenes
dc.publisherFrontierses
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/*
dc.subjectSex differenceses
dc.subjectPharmacokineticses
dc.subjectSunitinibes
dc.subjectEthics Committeeses
dc.subjectPrecision Medicinees
dc.titleSex-Divergent Clinical Outcomes and Precision Medicine: An Important New Role for Institutional Review Boards and Research Ethics Committeeses
dc.typereviewes
dc.rights.accessRightsopenAccesses
dc.description.disciplineFarmaciaes
dc.description.disciplineMedicinaes


Files in this item

This item appears in the following Collection(s)

Show simple item record

Attribution-NonCommercial-NoDerivatives 4.0 Internacional
Except where otherwise noted, this item's license is described as Attribution-NonCommercial-NoDerivatives 4.0 Internacional