Sex Proportionality in Pre-clinical and Clinical Trials: An Evaluation of 22 Marketing Authorization Application Dossiers Submitted to the European Medicines Agency

Sex Proportionality in Pre-clinical and Clinical Trials: An Evaluation of 22 Marketing Authorization Application Dossiers Submitted to the European Medicines Agency

This study assessed to what extent women were included in all phases of drug development; whether the clinical studies in the marketing authorization application dossiers include information per sex; and explored whether there are differences between women and men in the drugs' efficacy and saf...

Full description

Bibliographic Details
Main Authors: Marieke J. H. J. Dekker, Sieta T. de Vries, Carolien H. M. Versantvoort, Ellen G. E. Drost-van Velze, Mansi Bhatt, Peter J. K. van Meer, Ineke K. Havinga, Christine C. Gispen-de Wied, Peter G. M. Mol
Format: Article
Language:English
Published: Frontiers Media S.A. 2021-03-01
Series:Frontiers in Medicine
Subjects:
clinical trials
sex
sex distribution
proportionality
disease prevalence
efficacy
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2021.643028/full

Internet

https://www.frontiersin.org/articles/10.3389/fmed.2021.643028/full

Similar Items