505 Use of Expanded Access at Michigan Medicine and Associations with Neighborhood Factors
OBJECTIVES/GOALS: Socioeconomic status (SES) affects risk of disease and access to therapies. The expanded access (EA) pathway allows for the clinical use of investigational products for patients who have serious illness but no Food and Drug Administration (FDA)-approved therapeutic options. The SES...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2024-04-01
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| Series: | Journal of Clinical and Translational Science |
| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866124004291/type/journal_article |
| _version_ | 1827296118903406592 |
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| author | Misty Gravelin Jeanne Wright Shokoufeh Khalatbari Matheos Yosef Vikas Kotagal |
| author_facet | Misty Gravelin Jeanne Wright Shokoufeh Khalatbari Matheos Yosef Vikas Kotagal |
| author_sort | Misty Gravelin |
| collection | DOAJ |
| description | OBJECTIVES/GOALS: Socioeconomic status (SES) affects risk of disease and access to therapies. The expanded access (EA) pathway allows for the clinical use of investigational products for patients who have serious illness but no Food and Drug Administration (FDA)-approved therapeutic options. The SES of patients who receive EA is unknown. METHODS/STUDY POPULATION: We reviewed the patients who were approved for treatment through a single-patient EA pathway between 2018 and 2023. Using Michigan Medicine (MM) DataDirect software linked to the MM electronic medical record system, we linked the EA pathway patients to neighborhood data from the National Neighborhood Data Archive (NaNDA) to compare neighborhood related markers of affluence among EA patients and others treated at MM. We used descriptive statistics to compare variables between EA pathway patients and residents of the state of Michigan or the local county surrounding MM (Washtenaw County), using US Census tract data to provide context for these findings. RESULTS/ANTICIPATED RESULTS: MM patients who received EA treatments were more likely to come from neighborhoods that showed markers of high SES compared to residents of the state of Michigan but not Washtenaw County. This includes the proportion of persons living in poverty (12.5% EA / 13.4% Michigan / 12.4% Washtenaw) and education in the form of a bachelor’s degree or higher (32.2% / 30.6% / 57.2%). This varied by the disease being treated. Oncology patients were more likely to be from areas with less poverty and more education (12.4% / 76.8%) than the EA average. EA patients being treated for infectious diseases were from areas with more poverty and less education (13.5% / 26.7%). DISCUSSION/SIGNIFICANCE: Patients treated at Michigan Medicine using treatments obtained through the EA pathway came from areas that were, on average, more affluent than residents of the state of Michigan as a whole. This finding warrants more research to ensure equitable access to these therapies for patients in disadvantaged neighborhoods. |
| first_indexed | 2024-04-24T14:33:38Z |
| format | Article |
| id | doaj.art-c9bcbd00a6904a22abbabafec4093467 |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-04-24T14:33:38Z |
| publishDate | 2024-04-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-c9bcbd00a6904a22abbabafec40934672024-04-03T02:00:00ZengCambridge University PressJournal of Clinical and Translational Science2059-86612024-04-01814915010.1017/cts.2024.429505 Use of Expanded Access at Michigan Medicine and Associations with Neighborhood FactorsMisty Gravelin0Jeanne Wright1Shokoufeh Khalatbari2Matheos Yosef3Vikas Kotagal4University of Michigan – Michigan MedicineUniversity of Michigan – Michigan MedicineUniversity of Michigan – Michigan MedicineUniversity of Michigan – Michigan MedicineUniversity of Michigan – Michigan MedicineOBJECTIVES/GOALS: Socioeconomic status (SES) affects risk of disease and access to therapies. The expanded access (EA) pathway allows for the clinical use of investigational products for patients who have serious illness but no Food and Drug Administration (FDA)-approved therapeutic options. The SES of patients who receive EA is unknown. METHODS/STUDY POPULATION: We reviewed the patients who were approved for treatment through a single-patient EA pathway between 2018 and 2023. Using Michigan Medicine (MM) DataDirect software linked to the MM electronic medical record system, we linked the EA pathway patients to neighborhood data from the National Neighborhood Data Archive (NaNDA) to compare neighborhood related markers of affluence among EA patients and others treated at MM. We used descriptive statistics to compare variables between EA pathway patients and residents of the state of Michigan or the local county surrounding MM (Washtenaw County), using US Census tract data to provide context for these findings. RESULTS/ANTICIPATED RESULTS: MM patients who received EA treatments were more likely to come from neighborhoods that showed markers of high SES compared to residents of the state of Michigan but not Washtenaw County. This includes the proportion of persons living in poverty (12.5% EA / 13.4% Michigan / 12.4% Washtenaw) and education in the form of a bachelor’s degree or higher (32.2% / 30.6% / 57.2%). This varied by the disease being treated. Oncology patients were more likely to be from areas with less poverty and more education (12.4% / 76.8%) than the EA average. EA patients being treated for infectious diseases were from areas with more poverty and less education (13.5% / 26.7%). DISCUSSION/SIGNIFICANCE: Patients treated at Michigan Medicine using treatments obtained through the EA pathway came from areas that were, on average, more affluent than residents of the state of Michigan as a whole. This finding warrants more research to ensure equitable access to these therapies for patients in disadvantaged neighborhoods.https://www.cambridge.org/core/product/identifier/S2059866124004291/type/journal_article |
| spellingShingle | Misty Gravelin Jeanne Wright Shokoufeh Khalatbari Matheos Yosef Vikas Kotagal 505 Use of Expanded Access at Michigan Medicine and Associations with Neighborhood Factors Journal of Clinical and Translational Science |
| title | 505 Use of Expanded Access at Michigan Medicine and Associations with Neighborhood Factors |
| title_full | 505 Use of Expanded Access at Michigan Medicine and Associations with Neighborhood Factors |
| title_fullStr | 505 Use of Expanded Access at Michigan Medicine and Associations with Neighborhood Factors |
| title_full_unstemmed | 505 Use of Expanded Access at Michigan Medicine and Associations with Neighborhood Factors |
| title_short | 505 Use of Expanded Access at Michigan Medicine and Associations with Neighborhood Factors |
| title_sort | 505 use of expanded access at michigan medicine and associations with neighborhood factors |
| url | https://www.cambridge.org/core/product/identifier/S2059866124004291/type/journal_article |
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