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 women in clinical trials.
Evaluating the clinical comparability of U.S. vs. non-U.S. clinical trial data for FDA-regulated medical devices for obesity treatment - Dongyi (Tony) Du, PhD/CDRH (19)
In the U.S., obesity is of epidemic proportions and has been on the rise increasing from 20.9% of the population being obese to 33.8% in the last ten years. Obesity has been combatted using various methods including bariatric surgery, drugs, behavior modification, as well as medical devices. As one of the treatment options for weight loss, medical devices intended for obesity treatment must be deemed to be safe and effective, which is often assessed in clinical studies, in which participants are assigned to receive one or more treatments. These studies would enable the direct comparison of different treatment options. However, they can also be time consuming and costly. ClinicalTrials.gov contains information on clinical trials, many of which take place in the U.S. However, there are other sources of data on clinical trials that are not U.S. based, which may provide additional information on the safety and effectiveness of FDA-regulated medical devices. The proposed study aims to compare clinical trials from U.S. vs. non-U.S. clinical trials (specifically participant characteristics) to potentially identify supplementary information to what is known and potentially aid in regulatory decisions. Data will be used from ClinicalTrials.gov for U.S. clinical trials and from 22 foreign and international clinical trial registries previously identified by the U.S. Department of Health and Human Services (HHS). Specifically, we will examine clinical trials for the following obesity treatment devices that have received FDA approval: gastric bands, vagus nerve modulator, intragastric balloons, and gastric emptying systems.
Plasma Biomarkers in Perimenopause-Onset Depression - Gioia Guerrieri, DO/CDRH (18)
The transition into menopause can be a time when a woman is at risk for a first episode of depression or when a depression might recur in a woman who had a depression when she was younger. There are multiple theories about what might cause that risk. One of those theories considers that increased blood levels of inflammation, called biomarkers, or other metabolic biomarkers might contribute to that increased risk of depression. The aim of this study was to evaluate those markers of inflammation in two groups of women: women who enter the menopause transition and have no mood symptoms of depression symptoms (and never had them) and women who enter the menopause transition who are starting to have symptoms of depression. These women are between the ages of 40 and 60 years and started having irregular menstrual cycles but haven’t stopped having menstrual cycles completely. This study included 150 women with confirmed depression symptoms and were in the menopause transition and 100 women without depression who were also in the menopause transition. All women were medically healthy. By trying to find differences in the biomarkers of the two groups, scientists might be able to better determine the triggers of depression in women as they get older.
Individual patient-data meta-analysis and postmarket analysis as a method for improving data quality in demographic subgroups (Support for implementation of FDASIA Section 907 Action Plan) - Daniel Canos, PhD/CDRH (15)
Women have been underrepresented in clinical trials for medical devices and cardiovascular devices in particular. Therefore, the results of these trials primarily reflect outcomes in men. Directly addressing the FDASIA 907 Action Plan priorities of improving the quality and public availability of demographic subgroup data the current project will combine clinical trial data submitted to the FDA as part of pre-market approval applications. This allows for the analysis of sex-differences in medical devices, hereby leveraging existing clinical data and improving methodology for performing sex-specific analysis as individual clinical trials are often underpowered to detect potential sex-differences. Furthermore, a second step this project will pool pre-market and post-market data to assess sex-differences in real-world use thereby strengthening the system to make better use of data once medical products are available on the market. By combining already existing pre-market clinical trial data and assessing post-market real-world performance this study will be able to quickly evaluate device performance in demographic subgroups. Next to recommendations for future individual-patient data meta-analyses as a result of this project, this will also lead to rapid implementation into the regulatory review process and guidance documents, better clinical trial designs, and improve women’s health supporting multiple FDASIA priorities and action items.
Evaluation of gender-related clinical pharmacology information in the labeling on adverse events and outcomes - Lei Zhang, PhD, CDER (10)
Identification of Sex Differences in Adverse Outcomes for New Molecular Entities (NMEs) Approved from 2000-2002 - Yongsheng Yang, PhD, CDER (07)
Participation of Women in Clinical Trials and Gender Analysis in Original NDAs Approved 2000-2002 - Yongsheng Yang, PhD, CDER (06)
Women in HIV Trials: A comprehensive Review and Meta-analysis - Greg Soon, PhD, CDER (06)
Gender Differences and Impact of Pharmacogenomics in Rheumatoid Arthritis - Shashi Amur, PhD, CDER (06)
Impact of Gender Analysis and Pharmacogenomics on Clinical Efficacy, Safety, and Pharmacokinetics of Drugs Used for the Treatment of Alzheimer's Disease - Angela Men, PhD, CDER (06)
Statistical analysis of gender specific data from New Drug Application (NDA) submissions - Ohidul Siddiqui, PhD, CDER (06)
Evaluation of Availability and Quality of Information Available on Females Included in Mechanical device Implant Trials - Kathryn O'Callaghan, CDRH (06)
Women’s participation in clinical drug trials for unstable angina and myocardial infarction - Ann Farrell, MD, CDER (00)
FDA Scholarship in Women’s Health Program: Participation of Females in Clinical Trials and Gender Analysis of Data in Biologic Product Applications - Marion Gruber, PhD, CBER (2000)
Development and expansion of a pilot tracking system for monitoring the barriers to the enrollment of women in clinical trials - Toigo, Teresa, OC/OEA (95)