2023 Volume 33 Issue 1 Pages 33-40
In May 2021, it was reported that unexpectedly-large amount of case on menstrual modulation after COVID-19 vaccination were gathered in the UK Yellow Card Reporting. In October 2022, the European Medicines Agency recommended that a side effect of unknown frequency for severe menstrual bleeding be added to the product information of the mRNA-based COVID-19 vaccine. In Japan, nearly 90% of post-vaccine anaphylaxis cases up to April 2021 were female. The articles reviewing clinical studies on COVID-19 from a sex/gender perspective cited the failure to analyze and report data based on sex/gender. These “unanalyzed risks” and “quality of life reductions that cannot be addressed or claimed” may affect not only the individual's quality of life but also the public health. This situation has led to a (renewed) focus on the issues regarding sex and gender in clinical and biomedical research.
Research funding agencies and other organizations in Europe and the U.S. have mandated a balance between both sexes as clinical research subjects, and a meaningful analysis based on sex and gender. A guideline has also been developed by the European Association of Science Editors to guide researchers in writing articles. In Japan, the national research funding agency (The Japan Society for the Promotion of Science) states that, “...from the perspective of considering the diversity of review committee members, efforts will be made to appoint female researchers and researchers from public and private universities, independent administrative institutions, and private companies.” However, no action regarding clinical research itself has been taken. As a reference for actions to consider in Japan, this research paper introduces educational and other materials for researchers that are made available by various agencies, and suggests measures necessary to promote gender-inclusive clinical research.
