A Message from the Connors Center about the NIH Revitalization Act’s 30th Anniversary

June marks the 30th anniversary of the NIH Revitalization Act, which directed the National Institute of Health to establish guidelines for inclusion of women and minorities in clinical research. This marked a turning point, as more organizations and groups across the world implemented similar policies. In the following years, recognition of over-reliance on male animals and cells in preclinical research, as well as a lack of sex- and gender-disaggregated data reporting inspired further policy changes. This includes the NIH Policy on Sex as a Biological Variable, which required the consideration of biological sex in the design, analyses, and reporting of animal and human NIH-funded research since 2016.

Since then, further laws, policies, and guidance, together with rising awareness, and a growing presence of women within the scientific research community, have led to further advances, however, this progress has been uneven. Cardiovascular disease and cancer clinical trials still see lags in women’s participation, pregnant and lactating women are excluded from most clinical trials, and insufficient stratification of results by sex and gender persists. To learn more about the lack of adequate inclusion of women and sex/gender-related data in clinical research, we suggest reading: Sosinsky, et al.,  Montemitro, et al. and Bartz et al.

As a result of the limited inclusion of women and the scant consideration of biological sex and sociocultural gender variables in research and regulatory pathways, there is a dearth of knowledge on how these factors influence the safety and efficacy profiles of medical devices and pharmacotherapies, thus reducing the precision of knowledge for optimized care delivery.

The Connors Center has long advocated for the importance of an adequate inclusion of women and for the consideration of sex/gender-related factors in clinical research. For a description of the critical actions that need to be taken to address these issues we suggest reading, Spagnolo, et al. and Rich-Edwards, et. al.

We work to create awareness of and strategies to counter practices that systematically overlook sex and gender-related factors in clinical trials. The Connors Center achieves this through foundational science and clinical investigation, educational and training programs, and stimulation of discussions amongst the multi-stakeholder community in the bioscience ecosystem (including researchers, regulators, and industry bodies). In the last five years, We have supported over 70 fellows and awardees and over 120 members in conducting studies aimed at uncovering sex-differences in disease etiopathogenesis, course, and outcomes (including treatment response) as well as the development of innovative solutions to improve the health of women. Furthermore, we continue to support interdisciplinary projects that increase sex and gender equity in healthcare.

To mark the importance of the 30th anniversary of the NIH Revitalization Act, Connors Center Executive Director Hadine Joffe, MD, MSc joined WHAM! (Women’s Health Access Matters) at their celebration of the anniversary and participated in a roundtable discussion about how to accelerate research and investment in the health of women. A summary of the event can be found here. Below, we have also outlined some of the Connors Center’s most significant programs and studies which exemplify the Copernican revolution in clinical research initiated by the NIH revitalization act.

This anniversary, however, is also a powerful reminder that further actions are needed to ensure the sex and gender are adequately considered in clinical research. We look forward to continuing to work with you- our friends, colleagues, and supporters- to fund critical research and push for change across the field.  No single solution will be determinative, but a multiplicity of efforts is required to increase the accountability of the clinical research field in achieving the goal of better health for girls, boys, women, men, and gender diverse people worldwide.

ROSA Center:

Through the Office of Research in Women’s Health, which was established after the passing of the NIH Revitalization Act, the Connors Center oversees the Reproductive Outcomes of Stress and Aging (ROSA) Center, one of 11 Specialized Centers of Research Excellence (SCORE) nationwide on Sex Differences. The ROSA Center is a collaborative network of leading investigators examining the role of stress and its neural mechanisms in reproductive aging health outcomes that confer susceptibility to cardiovascular disease and dementia in aging women. Learn more about ROSA here.

First.In.Women® Precision Medicine Platform:

First.In.Women is a translational research platform that advances the inclusion and specific investigation of women in the development and utilization of new drugs, devices and digital therapeutics in order to produce sex-specific and sex-differentiating knowledge about newly developed treatments. FiW focuses on diseases that affect women exclusively, predominantly, or differentially. Through FiW programs like the IGNITE awards, First.In.Women fellowship, and partnerships with stakeholders to support research into sex and gender factors.  Learn more about First.In.Women here.

WHISPR:

Women’s Health Interdisciplinary Stress Program of Research examines the effects of stress on the health of women and convenes a community of stress investigators at Brigham and Women’s Hospital. At the 2023 WHISPR symposium Dr. Cynthia Rogers gave a keynote address entitled “Addressing Social Determinants to Optimize Perinatal and Neonatal Well-Being”, which discussed the importance of diversity and inclusion in research and treatment. Watch the symposium recording here.

Find recent publications related to sex and gender research from Connors Center members here.