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  1. Minority Health and Health Equity Research and Collaboration
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The Office of Minority Health and Health Equity (OMHHE) Research and Collaboration Program works with FDA centers to support research studies about minority health and health disparities. Research under this program provides insight into the scientific basis for individual therapies. Studies also provide future directions for research and aid regulatory decision-making. This program includes:

  • OMHHE Challenge Grants that support FDA research.
Project Awarded To Fiscal Year Status
Examining ethnic and racial disparities in critical care delivery to heart failure patients with artificial intelligence (AI) and real-world data (RWD) NCTR 2022 On Going
Assessment of Racial/Ethnic Diversity in BPCA/PREA Pediatric Clinical Trials Submitted to the US FDA OC 2022 On Going
Minimizing the impact of skin pigmentation in optical diagnostic devices through science-based best practices: literature review and numerical analysis CDRH 2022 On Going
Real-World Evidence Study on the Accuracy of Pulse Oximeters CDRH 2022 On Going
Define and Overcome Gaps Between Clinical Trial Evidence (CTE) And Real-World Evidence (RWE) For Sickle Cell Disease (SCD) Therapy And Outcomes CDER 2021 On Going
Racial and Ethnic Differences in Severe and Critical Hospitalizations and Mortality for COVID-19 Among Adults Under 65 CDER 2021 On Going
Development of Reference Panel for Rh Variants Blood Group Genotyping to Improve Transfusion Outcomes in Sickle Cell Disease Patients CBER 2020 Complete
Validation of Epigenetic Biomarkers in Peripheral Blood Mononuclear Cells From African American and European American Women With Systemic Lupus Erythematosus NCTR 2020 On Going
Phantom-based test methods for evaluating skin pigmentation-based disparities in performance of photoacoustic breast imaging systems CDRH 2020 On Going
Childhood Obesity: A Focus Group Study with English- and Spanish-Speaking Hispanic Low-Income Parents CFSAN 2019 On Going
Identification of genetic determinants of the susceptibility to nonalcoholic fatty liver disease NCTR 2019 Complete
Evaluating the clinical comparability of U.S. vs. non-U.S. clinical trial data for FDA-regulated medical devices CDRH 2019


Evaluation of the correlation of ethnicity-related neuroinflammation differences in Alzheimer’s disease with ER stress-induced endothelial dysfunction in the brain NCTR 2018 Complete
A Pilot Database of Pharmacogenomics Biomarkers for Application to the Minority Groups NCTR 2018 Complete
Evaluating Skin‐Pigmentation‐Based Disparities In Performance Of Nearinfrared Cerebral Oximeters Using Phantom‐Based Test Methods (Year 2: Tissue Phantom Optimization And Confounding Biological Factors) CDRH 2018 Complete
Rapid Message Testing with Consumer Panels CDER 2017 Complete
Evaluating skin-pigmentation-based disparities in performance of near-infrared cerebral oximeters using phantom-based test methods CDRH 2017 Complete
Studying Interactions between hepatitis B vaccines and hepatitis B immune globulin in newborn mice CBER 2017 Complete
Science of Engagement: Advancing Scientific Knowledge and Subpopulation Analysis for Minority Populations by Structuring Stakeholder Data into Meaningful Information and Analyzable Datasets CDER 2017 Complete
An Examination of Advertising and Promotional Labeling in Adult Immunization Disparities CBER 2016 Complete
Molecular Characterization of Racial Disparities and Outcome in Multiple Myeloma CDER 2015 Complete
An Epigenome-Wide Association Study (EWAS) of Peripheral Blood Mononuclear Cells from African American and European American Women With and Without Lupus NCTR 2015 Complete
Investigation of Human Cytomegalovirus Strain-Specific Neutralizing Antibody Responses in Racial/Ethnic Minorities CBER 2015 Complete
Alzheimer’s disease (AD) in African Americans and Caucasians:  Comparisons of biomarkers of inflammation in human tissues NCTR 2014 Complete
The development of anti-drug antibodies to therapeutic-proteins: The Pharmacogenetic basis for poor outcomes in minority populations CBER 2014 Complete
Improving transfusion outcomes through development of blood group genotyping reference panels CBER 2014 Complete



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