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A gender-medicine post hoc analysis (MetaGeM) project to test sex differences in previous observational studies in different diseases: methodology

Authors Colombo D, Bellia G, Vassellatti D, Zagni E, Sgarbi S, Rizzoli S

Received 18 May 2014

Accepted for publication 26 June 2014

Published 13 October 2014 Volume 2014:6 Pages 111—116

DOI https://doi.org/10.2147/OAJCT.S67914

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3

Video abstract presented by Delia Colombo

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Delia Colombo,Gilberto Bellia,Donatella Vassellatti,Emanuela Zagni,Simona Sgarbi,Sara Rizzoli2

1
Novartis Farma, Origgio, 2MediData, Modena, ltaly 

Abstract: Only recently has medical research begun to understand the importance of taking sex into account, recognizing that symptoms and responses to medical treatment may be very different between males and females. However, the analyses provided by the pharmaceutical industry to regulatory authorities often do not present safety and efficacy data by sex. Novartis has started a gender-medicine project called MetaGeM, which includes nine observational studies sponsored by Novartis Farma, Italy; conducted in Italy between 2002 and 2013 in a range of different clinical areas. The MetaGeM project aims to analyze and describe by means of post hoc analyses and meta-analyses, clinical outcomes, therapeutic approaches, and safety data of these studies, by sex: PSYCHAE; GENDER ATTENTION in psoriasis; Synergy in psoriatic arthritis; ICEBERG in HBsAg carriers; SURF and CETRA in liver- and renal transplanted patients, respectively; DEEP in Parkinson's disease; and EVOLUTION and AXEPT in Alzheimer's disease. The present paper describes the methodology of the MetaGeM project.

Keywords: gender-medicine, MetaGeM project, methodology

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