The FDA Office of Women’s Health (OWH) awards research grants for 1-2 year studies to support FDA regulatory decision-making and advance the science of women’s health. OWH has funded research projects that address health issues affecting women across their lifespan. This page highlights OWH-funded research related to sex differences.
Evaluating Inferior Vena Cava Filter Performance in Women Using Patient-Specific Computational Modeling - Brent Craven, PhD/CDRH (19)
Pulmonary embolism, the blockage of blood flow to the lungs by blood clots, is a leading cause of maternal death. Blood clots originate from the legs and pass through a large vein called the inferior vena cava (IVC) on their way to the heart and lungs. IVC filters are medical devices placed in the IVC to capture clots before they reach the lungs. Approximately 100,000 filters are placed in US patients each year, with filter placement commonly performed in pregnant women because of their 5-fold increased risk of developing clots during pregnancy and 60-fold increased risk postpartum. Commercial IVC filters come in a single size that is meant to accommodate both women and men. Women, however, have a shorter IVC with a smaller diameter compared to men. Additionally, filters are typically placed in a different location in the IVC of pregnant women to avoid potential complications. Such anatomical differences—and placement location in pregnant women—likely influence device performance. Typical laboratory testing performed to evaluate device safety and effectiveness, however, does not account for differences between women and men. In the proposed study we will: (i) develop a free and publicly available database of patient-specific IVC models in women and men, (ii) quantify sex-dependent anatomical differences, and (iii) use patient-specific computational modeling to determine if IVC filter performance (mechanics, blood flow, clot trapping) is sex-specific. We will focus on adult women of childbearing age since they are at an especially high risk of developing clots due to pregnancy and use of oral contraceptives, a group of age-matched men, and a pregnant woman. Our findings will be used to update recommended laboratory testing for IVC filters, and to explore recommendations for IVC filter design, use, and selection criteria for improved performance in women.
Improving FDA Health Communications with Older Women Regarding FDA-Regulated Products. (Cross-Center Collaboration Project) - Marc Kusinitz, MS, PhD/CBER (18)
Nearly one-third of the current U.S. population is aged 50 years or older, and this proportion is expected to increase dramatically by 2050. Half of these older adults are women. Unlike younger women, older women face the increasing burden of chronic health conditions, for which they often use FDA-regulated medical products and recommended diet modifications to maintain their health, or treat or prevent health complications. Many older women also have dual roles, as both patient and caregiver, which compounds the challenges of making health-related decisions. These challenges are further complicated in those 68% or more of older adults who have difficulty using print materials, interpreting numbers, and performing basic calculations. Such limited health literacy among these older adults contributes to health disparities, worse health outcomes, increased use of healthcare facilities and products, and more medication errors. Yet, there has been no research to identify the difficulties that older adults – specifically older women – might face in understanding and using information provided by FDA. Therefore, it is critical for FDA to produce easily understood materials that teach older women how to use FDA-regulated products safely and effectively.
This study aims to collect data that FDA Centers can use to inform the development of more effective health communications related to FDA-regulated products that target older women, defined here as US women aged 50 years and older. In Phase 1 of the proposed study, the investigators will collect information from focus groups composed of older women to better understand the perceptions, including how older women view the adequacy, appropriateness, usefulness, and relevance of health communications associated with FDA-regulated products. In Phase 2, the investigators will conduct a national survey of older women to explore their perceptions of FDA health communications and their health-information seeking behaviors and intentions.
If successful, the proposed research will support efforts to provide effective and easily understood information about FDA-regulated products to older women that can help them use such products appropriately.
In silico research on sex differences in the biological responses and adverse events elicited by implantable devices/biomaterials (Special Funding)- Yelizaveta (Lisa) Torosyan, PhD/CDRH (17)
The current project is aligned with the CDRH’s regulatory science initiatives and it serves the Center’s vision for the National System for Medical Device Evaluation that can provide access to safe and effective devices by accurately characterizing real-world performance throughout the total product life cycle and by delivering “the right device to the right person.” As part of the CDRH's regulatory research efforts aimed at strengthening medical device evaluation, new evidentiary approaches are needed to individualize risk-benefit assessment and facilitate more predictive evaluation of real-world performance. The approaches proposed in this project will utilize a novel in silico framework which harnesses recent advances in bioinfomatics, translational epidemiology, and genetics/genomics. In addition to employing conventional data sources such as device registries, the open-access and other pre-existing biomedical data sources will be explored for possibilities of identifying device-related genetic/genomic evidence and discovering new reliable and measurable study endpoints (e.g., molecular biomarkers) that are more indicative of device performance in patient subsets (e.g., sex-stratified subpopulations). As a result, the project's is expected to enhance regulatory decision-making on long-term device performance and to promote Precision Medicine applications, thereby improving device-related patient outcomes.
Evaluation of the Extent and Impact of Gender Sensitive Advertising and Promotional Labeling of Health Products (Special Funding)- Oluchi Elekwachi, PharmD/CBER (17)
The Effects of Gender Differences in Revision Rates for Spinal Total Disc Replacement Procedures - Srinidhi Nagaraja, PhD, CDRH (13)
Sex differences in biomarkers of kidney injury in patients with metal-on-metal hip implants - Ronald Brown, MS, CDRH (13)
Gender differences in neuronal reward circuit activation by nicotine and tobacco smoke using magnetic resonance spectroscopy - Serguei Liachenko, PhD, NCTR (12)
Sex differences in kidney biomarker response following exposure to an orthopedic alloy: Implications for the safety assessment of metal-on-metal hip implants - Ronald Brown, MS, CDRH (12)
Gender effect on PK/PD of hypnotic drug: Driving impairment and dosing recommendations - Jagan Mohan Parepally, PhD, CDER (12)
Pharmacokinetics (PK) and biomarkers of the medications used to treat multiple sclerosis (MS) – any gender difference? - Wu Ta-Chen, PhD, CDER (11)
A pilot study on performing sex analysis on a vaccine database - Jingyee Kou, PhD, CBER (10)
“Sex Differences in FDA Regulated Products: Research for the Future” seminar series - Beverly Lyn-Cook, PhD, NCTR (09)
Mechanisms of Gender Differences in Aspirin Effects: Metabolizing Enzymes and Therapeutic Targets - Baitang Ning, PhD, NCTR (07)
CYP2B6 Genotype-Phenotype and the Influence of Sex and Ethnicity - Erin G. Schuetz, PhD, St. Jude’s Research Hospital (05)
Gender Differences in the Willingness to Read and Follow Patient Information - Ellen Tabak, PhD, CDER (04)
Gender effect on the assessment of bioavailability and bioequivalence in bioequalence trials - Mei Ling Chen, PhD, CDER (01)
Development and characterization of conditionally immortalized human primary hepatocyte cell lines from female and male donors- Phase I - Angela Harris, PhD, NCTR (02)
Mechanistic basis for gender-dependent differences in pharmacokinetics - Chandra Sahajwalla, PhD, CDER (99)
Gender differences in P450 activities and their implications - Shiew Mei Huang, PhD, Robert Branch, PhD, CDER (98)
Gender differences in perception of risks communicated by prescription and over-the-counter drug labels, Phase I and II - Ellen Tabak, PhD, CDER (95)