Invisible Variables: How the Underrepresentation of Women in Clinical Trials Skews Modern Medicine
Aanushree Shrestha, Jay Prakash Jha
Citation: Aanushree Shrestha, Jay Prakash Jha, "Invisible Variables: How the Underrepresentation of Women in Clinical Trials Skews Modern Medicine", OAS Journal of Medical and Health Sciences, Volume 01, Issue 01.
Copyright: This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background: Clinical research has predominantly enrolled male participants throughout the history, often at an expense of women’s representation. Such gender disparity has raised concerns about the generalization of research findings and the safety of pharmacological interventions. This denotes a fundamental flaw in medical research, giving rise to our limited understanding of sex-based medicine.
Objective: This review examines the causes, extent and consequences of the underrepresentation of women in clinical trials, and also highlights recent advancements made towards gender inclusion.
Methods: A narrative review of peer-reviewed literature, regulatory documents, and international policy frameworks was conducted, drawing on evidence from the diverse aspects of medicine, ethics, society and health policy. Thematic analysis of the content was made according to the scope of the review.
Result and Conclusions: Gender disparity in clinical trials has led to significant challenges in drug and vaccine safety, disease diagnosis and management and bias in modern technologies. Equitable representation of women in clinical research is both a scientific, imperative and an ethical obligation. Coordinated regulatory, methodological, and institutional reforms are required to address the underrepresentation and its downstream consequences.
Keywords: Adverse Drug Reactions; Artificial Intelligence; Clinical Trial; Gender Bias; Health Equity; Pharmacokinetics.
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