FDA Office of Minority Health and Health Equity Research Projects and Publications
Find research projects the FDA Office of Minority Health and Health Equity (OMHHE) supports, along with publications and supporting information when available.
Research studies under this program aim to advance our understanding of differences minority groups experience in disease prevalence and response to therapy.
Lupus affects African American women more often than European American women. FDA approved the Lupus drug Benlysta in 2011, however data from the clinical trials showed that the drug performed better on European American women. Therefore this study investigates a potential molecular basis for why the drug performed better on European American women than African American women.
African Americans have a higher prevalence of Alzheimer’s disease and more severe consequences of the disease. If researchers can identify the inflammatory biomarkers that are specific to African Americans, health providers could diagnose Alzheimer’s earlier and more accurately. They could also develop more therapies that are more effective for this population.
Alzheimer’s Disease (AD) in African Americans: Comparisons of Biomarkers of Inflammation in Human Tissues (Intramural, 2014)
By: Sherry Ferguson, PhD, National Center for Toxicological Research, FDA
Research aims to create the initial dataset for a knowledge base of potential race-related differences in inflammation-related biomarkers measured in different post-mortem human tissues with Alzheimer's disease in African American and Caucasian groups.
Integrated Analysis of miRNA Expression and Copy Number in Triple Negative Breast Cancer of African American Women (Extramural, 2013)
By: Luciane Cavalli, PhD, Georgetown University
Research aims to conduct genomic profiling of African Americans to better understand the biology of triple negative breast cancer and identify markers to develop diagnostics and targeted therapies.
Investigating Factors Associated with Participation of Racial & Ethnic Minority Populations in FDA-Regulated Research (Extramural, 2012)
By: Sandra C. Quinn, PhD & Natasha Brown, PhD, MPH, University of Maryland, College Park
Researchers conduct key informant interviews with FDA staff, industry investigators, and clinical research organizations to understand and document current practices, and facilitators and barriers to successful inclusion of minorities in regulated trials.
Awareness, Willingness, and Barriers to Clinical Trial Participation, Biospecimen/Tissue Donation, Ethical Considerations Including Consent and Privacy Preferences (Extramural, 2012)
By: Claudia R. Baquet, MD, MPH, University of Maryland, Baltimore
Research examines factors and barriers related to clinical trial participation and tissue (or biospecimen) donation for research in minority, urban, and rural communities.
Genes, Culture, and Health Report (Extramural, 2012)
By: National Alliance for Hispanic Health
Research updates and revises the Genes, Culture, and Health report, which was first released in 2004, on the topics of Hispanic health disparities, genetic admixture, inclusion in genetic studies, and personalized medicine.
Reducing Disparities in Diabetes Treatment and Outcomes for Asians and Pacific Islanders Living in Hawaii (Extramural, 2012)
By: Daniel Y. Hu, PharmD, University of Hawaii, Hilo
Research examines perceptions and factors affecting pharmacological treatments and outcomes among Asian Americans/Native Hawaiians/Pacific Islanders with Type 2 diabetes and identifies if pharmacists and pharmacy schools play a role in reducing disparities.
Rapid Message Testing with Consumer Panels (Intramural, 2017)
By: Brian Lappin
This pilot study will use consumer panels similar to FDA’s target audiences, including lower literacy groups and racial/ethnic minorities, to view draft communications and provide feedback for improving them.
Science of Engagement: Advancing Scientific Knowledge and Subpopulation Analysis for Minority Populations by Structuring Stakeholder Data into Meaningful Information and Analyzable Datasets (Intramural, 2017)
By: Christine Lee, PharmD, PhD
This pilot study will analyze unstructured FDA data, as well as social media data, to better understand patients’ and caregivers’ perspectives on diabetes. The study will also assess the number and percentage of drug labels containing information on minorities as part of the Agency’s commitment under the FDASIA 907 Action Plan.
An Examination of Advertising and Promotional Labeling in Adult Immunization Disparities (Intramural, 2016)
By: Oluchi Elekwachi, PharmD
This pilot study will examine elderly (age 60 and over) patients understanding and perceptions of vaccinations, and assess the health literacy and cultural competency of advertising and promotional labeling for the Shingles vaccine, to better understand the differences in vaccination rates among whites and ethnic/racial minorities.
Assessing Dissemination of Health Information among Hispanics with Limited English Proficiency Accessing Rural Community Health Centers in the Midwest (Extramural, 2014)
By: Armando De Alba, MD, MPH, University of Nebraska Medical Center
Research aims to identify strategies for communicating health promotion/disease prevention information, safety alerts, and additional important information on medical products among Hispanics with limited English proficiency accessing healthcare in community health centers in urban and rural settings in the Midwest.
Re-Designing Electronic Health Records and Personal Health Records for Improved Chronic Care (Extramural, 2014)
By: Monifa Vaughn-Cooke, PhD, University of Maryland, College Park
Research uses a patient-centric design methodology to develop a database of information architecture and interface prototype focusing on the chronic disease information needs, requirements, and limitations of the minority patient population. The database will consist of design preferences that can be used by designers and personal health record vendors to insure that the system meets the usability needs of minority populations.
Health Literacy on Medical Products Supporting Aging in Place (Extramural, 2013)
By: Pamela A. Saunders, PhD, Georgetown University
Research aims to examine how older adults living in the community obtain and trust the information viewed on traditional and electronic media regarding medical products for individuals “aging in place” (i.e., in their own homes).
The Means by which the Mexican Immigrant Community of Douglas County, NE. Obtains its Health Education for Disease Prevention (Extramural, 2012)
By: Armando De Alba, MD, MPH, University of Nebraska Medical Center
This is a cross sectional study assessing health literacy and examining means by which Spanish speaking Mexican citizens living in the United States access health information.
Improving Health Literacy and Cultural Competence of FDA Consumer Materials (Extramural, 2012)
By: Olivia Carter-Pokras, PhD, University of Maryland, College Park
Study provides analysis and recommendations to the Food and Drug Administration (FDA) for improving communication and understanding of consumer information on webpages pertaining to HIV/AIDS prevention and treatment.
The Effects of Bacterial Vaginosis on Vaginal Epithelium HIV Infectivity: Implications for Mechanisms Linked to Health Disparities in HIV/ AIDS (Extramural, 2012-13)
By: Mack Hall III, PhD, Meharry Medical College
Research aims to establish an in-vitro vaginal epithelial cell infection model to examine the role of abnormal vaginal bacteria on increased risk for HIV-1 acquisition.
Disparities In Performance Of Near-Infrared Tissue Oximeters: Testing Device Sensitivity To Epidermal Melanin And Adipose Tissue (Intramural, 2017)
By: Joshua Pfefer
This study will determine the accuracy of near-infrared spectroscopy (NIRS)-based tissue oximeters when used with highly pigmented skin, and develop standardized testing methods for use during FDA review of these devices.
Improving Transfusion Outcomes Through Development of Blood Group Genotyping Reference Panels (Intramural, 2013-14)
By: Zhugong Liu, PhD, CBER
Research extended RBC matching is an effective strategy to reduce alloimmunization in patients with Sickle Cell Disease. The use of molecular typing kits will assist in developing extensively genotyped donor pools that allow for enhanced matching.
Safer Labeling of Pediatric Medications: Reducing Clinically Significant Disparities in Label Understanding among Chronically Ill Youth and their Families (Extramural, 2015)
By: Lee Sanders, MD, Stanford University
Research aims to apply existing validated tools to assess the literacy/readability/suitability and numeracy appropriateness of medication labels, and accompanying information, for medications commonly used by children with chronic conditions.
Racial/Ethnic Differences in Pediatric Antipsychotic Use by FDA Labeled Status (Extramural, 2013)
By: Julie M. Zito, PhD, University of Maryland, Baltimore
Research aims to learn whether labeled use of antipsychotics compared with usage for off-label conditions, (e.g. ADHD or disruptive disorders) differ with respect to race/ethnicity and type of insurance (private vs. public).
Knowledge Regarding Antidepressant Medication among Depressed Latino Patients in Primary Care (Extramural, 2013)
By: Bonnie L. Green, PhD, Georgetown University
Research aims to assess knowledge about antidepressant medication, and the source of that knowledge, among depressed Latino immigrants in primary care.
Effects of Menthol on Disparities in Tobacco Use for Native Hawaiians and Other Pacific Islanders Living in Hawaii (Extramural, 2012)
By: Elise Davis, MPH, University of Hawaii, Manoa
Research aims to assess knowledge, attitudes, and practices toward mentholated tobacco products among Native Hawaiians who have ever smoked tobacco.
Studying Interactions Between Hepatitis B Vaccines And Hepatitis B Immune Globulin In Newborn Mice (Intramural, 2017)
By: Marian Major
This study will analyze the response to the co-administration of Hepatitis B Immune Globulin (HBIG) and Hepatitis B Vaccines (HepB) in new-born mice, to better understand the response in human infants.