Division of Allergy, Immunology, and Transplantation (DAIT), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Radiation and Nuclear Countermeasures Program (RNCP), Rockville, MD, USA.
Office of Research on Women's Health (ORWH), Office of the Director, NIH, Rockville, MD, USA.
Int J Radiat Biol. 2024;100(3):466-485. doi: 10.1080/09553002.2023.2283089. Epub 2023 Nov 27.
The workshop addressed the role of sex as a confounder in radiation research and its implication in real-world radiological and nuclear applications.
In April 2022, HHS-wide partners from the Radiation and Nuclear Countermeasures Program, the Office of Research on Women's Health National Institutes of Health Office of Women's Health, U.S. Food and Drug Administration, and the Radiological and Nuclear Countermeasures Branch at the Biomedical Advanced Research and Development Authority conducted a workshop to address the scientific implication and knowledge gaps in understanding sex in basic and translational research. The goals of this workshop were to examine sex differences in 1. Radiation animal models and understand how these may affect radiation medical countermeasure development; 2. Biodosimetry and/or biomarkers used to assess acute radiation syndrome, delayed effects of acute radiation exposure, and/or predict major organ morbidities; 3. medical research that lacks representation from both sexes. In addition, regulatory policies that influence inclusion of women in research, and the gaps that exist in drug development and device clearance were discussed. Finally, real-world sex differences in human health scenarios were also considered.
This report provides an overview of the two-day workshop, and open discussion among academic investigators, industry researchers, and U.S. government representatives.
This meeting highlighted that current study designs lack the power to determine statistical significance based on sex, and much is unknown about the underlying factors that contribute to these differences. Investigators should accommodate both sexes in all stages of research to ensure that the outcome is robust, reproducible, and accurate, and will benefit public health.
本次研讨会探讨了性别作为辐射研究中的混杂因素的作用及其在实际放射学和核应用中的意义。
2022 年 4 月，来自辐射和核对策计划、美国国立卫生研究院妇女健康办公室研究妇女健康办公室、美国食品和药物管理局以及生物医学高级研究与发展管理局放射和核对策处的 HHS 范围内的合作伙伴进行了一次研讨会，以解决在基础和转化研究中理解性别的科学意义和知识差距。本次研讨会的目标是：检查 1. 辐射动物模型中的性别差异，并了解这些差异如何影响辐射医学对策的开发；2. 生物剂量测定和/或生物标志物用于评估急性辐射综合征、急性辐射暴露的延迟效应以及/或预测主要器官发病率；3. 缺乏两性代表性的医学研究。此外，还讨论了影响将妇女纳入研究的监管政策以及药物开发和设备清除方面存在的差距。最后，还考虑了人类健康场景中的实际性别差异。
本报告概述了为期两天的研讨会，以及学术研究人员、行业研究人员和美国政府代表之间的公开讨论。
本次会议强调，目前的研究设计缺乏根据性别确定统计学意义的能力，并且对于导致这些差异的潜在因素知之甚少。研究人员应在研究的所有阶段都兼顾两性，以确保研究结果具有稳健性、可重复性和准确性，并将有益于公共健康。
