Intramural Research
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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 |
Complete |
| 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 |