Transforming Health Care through Innovative and Impactful Research

August 26, 2024

Today marks 104 years since the passage of the 19^th Amendment granting women in the United States the right to vote. The Congressionally Directed Research Programs honors this milestone by celebrating the historic journey towards women's equality overall, including health equality.

In FY24, the CDMRP received over $1.5 billion in congressional appropriations for research to enhance the lives of Service Members and their Families, Veterans, and the American public. This funding targets critical gaps in research by focusing on innovative, high impact projects that will lead to cures or improvements in patient care, or breakthrough technologies and resources for clinical benefits.

CDMRP-funded research spans medical specialties, including those conditions unique to women, like endometriosis and maternal mental health; conditions that affect women disproportionately, like lupus and Alzheimer's disease; and conditions that may impact women differently, like PTSD, heart disease and musculoskeletal injuries.

"CDMRP is rooted in women's health," Gayle Vaday, Ph.D., CDMRP Civilian Deputy Director, said. "The organization is devoted to advancing the inclusion of women in medical research and understanding of women's health."

SEX-BASED GAPS IN MEDICAL RESEARCH

In 1985, the U.S. Public Health Service Task Force on Women's Health Issues recommended increased women's participation in clinical trials, and indicated that research should focus on conditions that are more common in women. In response, the National Institutes of Health, the leading federal organization responsible for medical and public health research, adopted a policy to require the inclusion of populations underrepresented in clinical research, including women and racial and ethnic minorities. Congress then passed the National Institute of Health Revitalization Act of 1993 requiring the inclusion of women and minorities in all NIH-sponsored clinical trials.

COLLABORATION DRIVES RESEARCH IMPACT AND INNOVATION

The FY19 Senate Report 115-290 directed the Department of Defense to develop a plan, in coordination with the NIH, to ensure appropriate representation of women and minorities in clinical research. Per the congressional direction, the CDMRP collaborated with the NIH and in 2021 established a policy on the Inclusion of Women and Minorities as Subjects in Clinical Research. This policy requires all CDMRP-funded clinical research to appropriately include women and individuals from minority groups, unless there is a clear, justifiable rationale not to include them.

In July 2024, the CDMRP established a policy on Sex as a Biological Variable in Research. The new policy, which is effective beginning with FY25 applications and awards, expects researchers to study both males and females across the full spectrum of basic, translational and clinical research, unless there is a strong justification for only studying one sex. The CDMRP also implemented language in FY24 funding opportunity announcements to encourage research in areas and conditions that impact women disproportionately, uniquely or differently than men. This includes studies to understand sex as a biological variable. Incorporating sex as a biological variable in research can improve the understanding of how and why males and females experience various health conditions and may respond to treatments differently.

Both policies advance the goal of improving the understanding of women's health.

CDMRP AWARDS WITH EMERGING OUTCOMES

Endometriosis, a condition that causes tissue like the lining of the uterus to grow outside of the uterus, impacts millions of women in the United States. This condition is linked with increased rates of autoimmune disorders, certain cancers and heart disease.

With funding from the CDMRP, Amy DiVasta, M.D., and her team at Children's Hospital, Boston, is investigating the use of a non-surgical, non-hormonal treatment for persistent pain caused by endometriosis. Pain management for endometriosis is challenging and insufficient. A cure for endometriosis is not currently available, and women affected by endometriosis must undergo long-term disease management that includes effective pain management medications safe for long-term use. Knowing endometriosis relies on the development of new blood vessels, DiVasta's team believes drugs that slow the growth of blood vessels are a promising treatment option and plan to repurpose an existing drug to treat chronic pelvic pain in women with endometriosis. To date, this clinical trial recruited a sufficient number of participants needed for clinical significance; participant recruitment and experimental treatment are ongoing, with results anticipated in the near future.

Heart disease and other cardiovascular diseases are the leading cause of death for women in the United States. PTSD is known to impact twice as many women as men. Some studies suggest that PTSD, a potentially debilitating psychological condition, is associated with, and may contribute to cardiovascular disease.

A study, led by Ramin Ebrahimi, Ph.D., and his team at the University of California, Los Angeles, focuses on how PTSD may be related to heart disease and other cardiovascular conditions in women Veterans, how common PTSD is in these women, and how other factors, such as environmental exposures and behaviors impact the development of heart conditions in women after their military service. To date, the research team identified an association between PTSD and the incidence of stroke and heart disease, and is examining trends for cardiac disease mortality for women Veterans compared to civilians.

RECENTLY FUNDED AWARDS - PROMISING OUTCOMES ON THE HORIZON

Nearly 1 in every 7 women will develop postpartum depression as the most common complication after childbirth. Maternal mental health impacts the mother and the new baby. The current standard of care for identifying postpartum depression is self-reporting and physicians responding to the reported symptoms. There are no biological tests to predict or treat postpartum depression in women.

Zachary Kaminski, Ph.D., and his team at Dionysus Digital Health, Inc., believe that incorporating a biological test into standard blood tests for pregnant women early in the third trimester may enable early detection, improve prevention, and lead to the development of interventions to improve maternal and child health outcomes.

Lack of sleep is a well-known, yet overlooked, contributor to postpartum mood disorders. Michele Okun, Ph.D., and her team and the University of Colorado, Colorado Springs, will investigate the use of a smart bassinet to decrease the risk of postpartum mood disorders for military-affiliated mothers compared to those who use a standard commercial bassinet. The smart bassinet aims to increase infant sleep while reducing nighttime disruption, thereby improving maternal sleep quality.

"Increased attention on women's health will lead to better, longer lives for women," Vaday said. "Improving women's health can not only lead to an increase in saved lives, but a reduction in health care costs."

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