ISSN: 2167-0870
Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, United States
Dr. Qing Hao is currently working in Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, United States. He has published numerous research papers and articles in reputed journals and has various other achievements in the related studies. He has extended his valuable service towards the scientific community with his extensive research work.
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
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DOI:
10.36648/2167-0870.21.11.447