Journal of Clinical Trials
Open Access

Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, United States

Publications

• Research Article   
  Are Women Underrepresented in Cerebrovascular Disease Clinical Trials? A Systematic Review using the FDA Database
  Author(s): Xiaobo Zhong* and Qing Hao
  
  Background and purpose: Clinical trials provide essential evidence in the US Food and Drug Administration (FDA) drug approval process. Women were underrepresented in the enrollment of clinical trials for many medical conditions other than Cerebrovascular Disease (CVD). We investigated women’s participation in FDA-registered CVD-related interventional clinical trials and assessed whether women CVD patients in the United States were underrepresented. We also evaluated the association between the underrepresentation and the features of design and operation among these trials. Methods: We systematically reviewed the phase 2 and 3 CVD-related interventional trials started in 2002–2017 in the FDA database. The proportions of women enrolled in these trials and the Proportion-to-Prevalence Ratios (PPRs), defined as the r.. View More»
  DOI: 10.36648/2167-0870.21.11.447

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