Inclusion of women in FDA-regulated premarket clinical trials: A call for innovative and recommended action

• Published in: Contemporary clinical trials Vol. 116; p. 106708
• Main Authors: Samaei, Mehrnoosh, McGregor, Alyson J., Jenkins, Marjorie R.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.05.2022
• Subjects: Cardiovascular; Clinical trials; FDA; Gender difference; Health policy; Hematology, Oncology, and Palliative Medicine; Sex based; Clinical trials; Sex based; FDA; Health policy; Gender difference
• ISSN: 1551-7144; 1559-2030; 1559-2030
• DOI: 10.1016/j.cct.2022.106708

Women were historically excluded from clinical trials. Despite numerous guidance and policy, we are still seeing this exclusion throughout the research pipeline more than 40 years later. The progress that has been made to include women in clinical trials and to report data disaggregated by sex continues to be limited due to multiple factors. In this paper, we aim to review some of the current FDA funding, policies, and practice in regard to inclusion of biological sex and sociocultural gender variables. This paper provides some recommendations and actionable policies to ensure that women as well as men can benefit from the updated biomedical research and clinical trials designed to take these variables into account. Strong regulations and mandates should be in place to direct pharmaceutical companies and industry toward the inclusion of women in biomedical research instead of a series of guidelines and recommendations that have not led to sufficient progress. Additionally, regulatory agencies should be completely independent in their decision-making process. Provision of Food and Drug Administration (FDA) funding by industry user fee for instance, might compromise FDA's impartiality in the approval process. Finally, better oversight is needed by the FDA for the labeling of drugs. FDA has made a significant contribution to the progress that has been made to this date, however, some of the current action plans including the Drug Trial Snapshots need to be refined to be more responsive to the current needs.