Adapting an Expanded Access program to enable investigational treatments for COVID-19
Retrospective case studies of initiatives supported by the National Institutes of Health’s Clinical and Translational Science Award (CTSA) hubs can be used to identify facilitators and barriers of translational science. This case study investigates how a CTSA Expanded Access program adapted to chang...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2022-01-01
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| Series: | Journal of Clinical and Translational Science |
| Subjects: | |
| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866122004034/type/journal_article |
| _version_ | 1811156518037356544 |
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| author | Elias Samuels Ellen Champagne Misty Gravelin Jamie Racklyeft Kevin Weatherwax |
| author_facet | Elias Samuels Ellen Champagne Misty Gravelin Jamie Racklyeft Kevin Weatherwax |
| author_sort | Elias Samuels |
| collection | DOAJ |
| description | Retrospective case studies of initiatives supported by the National Institutes of Health’s Clinical and Translational Science Award (CTSA) hubs can be used to identify facilitators and barriers of translational science. This case study investigates how a CTSA Expanded Access program adapted to changing FDA guidance issued in 2020 to support clinicians’ treatment of COVID-19 patients in Michigan. We studied how this program changed throughout the pandemic to support physicians’ requests for remdesivir, convalescent plasma, and other uses of unapproved drugs and novel medical devices. A protocol for retrospective translational science case studies of health interventions developed by CTSA evaluators was used for this case study. Data collection methods included seven interviews and a review of institutional data, peer-reviewed publications, news stories, and other public records. The barriers identified include evolving guidance, misalignment of organizational operations, and the complexity of the research infrastructure. The facilitators of translation include collaboration between research and care teams, increasing engagement with a broad network of supporters, and ongoing professional development for research staff. The findings of this case study can be used to inform future investigations of the principles underlying the translational process. |
| first_indexed | 2024-04-10T04:53:01Z |
| format | Article |
| id | doaj.art-cf1793642b4347b9869280f564c0fd79 |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-04-10T04:53:01Z |
| publishDate | 2022-01-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-cf1793642b4347b9869280f564c0fd792023-03-09T12:31:04ZengCambridge University PressJournal of Clinical and Translational Science2059-86612022-01-01610.1017/cts.2022.403Adapting an Expanded Access program to enable investigational treatments for COVID-19Elias Samuels0https://orcid.org/0000-0002-6725-3382Ellen Champagne1Misty Gravelin2Jamie Racklyeft3Kevin Weatherwax4https://orcid.org/0000-0001-6023-1669Michigan Institute for Clinical & Health Research, University of Michigan, Ann Arbor, MI, USAMichigan Institute for Clinical & Health Research, University of Michigan, Ann Arbor, MI, USAMichigan Institute for Clinical & Health Research, University of Michigan, Ann Arbor, MI, USAMichigan Institute for Clinical & Health Research, University of Michigan, Ann Arbor, MI, USAMichigan Institute for Clinical & Health Research, University of Michigan, Ann Arbor, MI, USA College of Pharmacy, University of Michigan, Ann Arbor, MI, USARetrospective case studies of initiatives supported by the National Institutes of Health’s Clinical and Translational Science Award (CTSA) hubs can be used to identify facilitators and barriers of translational science. This case study investigates how a CTSA Expanded Access program adapted to changing FDA guidance issued in 2020 to support clinicians’ treatment of COVID-19 patients in Michigan. We studied how this program changed throughout the pandemic to support physicians’ requests for remdesivir, convalescent plasma, and other uses of unapproved drugs and novel medical devices. A protocol for retrospective translational science case studies of health interventions developed by CTSA evaluators was used for this case study. Data collection methods included seven interviews and a review of institutional data, peer-reviewed publications, news stories, and other public records. The barriers identified include evolving guidance, misalignment of organizational operations, and the complexity of the research infrastructure. The facilitators of translation include collaboration between research and care teams, increasing engagement with a broad network of supporters, and ongoing professional development for research staff. The findings of this case study can be used to inform future investigations of the principles underlying the translational process.https://www.cambridge.org/core/product/identifier/S2059866122004034/type/journal_articleRetrospective case studiesClinical Translational Science AwardCTSAExpanded AccessCOVID-19 |
| spellingShingle | Elias Samuels Ellen Champagne Misty Gravelin Jamie Racklyeft Kevin Weatherwax Adapting an Expanded Access program to enable investigational treatments for COVID-19 Journal of Clinical and Translational Science Retrospective case studies Clinical Translational Science Award CTSA Expanded Access COVID-19 |
| title | Adapting an Expanded Access program to enable investigational treatments for COVID-19 |
| title_full | Adapting an Expanded Access program to enable investigational treatments for COVID-19 |
| title_fullStr | Adapting an Expanded Access program to enable investigational treatments for COVID-19 |
| title_full_unstemmed | Adapting an Expanded Access program to enable investigational treatments for COVID-19 |
| title_short | Adapting an Expanded Access program to enable investigational treatments for COVID-19 |
| title_sort | adapting an expanded access program to enable investigational treatments for covid 19 |
| topic | Retrospective case studies Clinical Translational Science Award CTSA Expanded Access COVID-19 |
| url | https://www.cambridge.org/core/product/identifier/S2059866122004034/type/journal_article |
| work_keys_str_mv | AT eliassamuels adaptinganexpandedaccessprogramtoenableinvestigationaltreatmentsforcovid19 AT ellenchampagne adaptinganexpandedaccessprogramtoenableinvestigationaltreatmentsforcovid19 AT mistygravelin adaptinganexpandedaccessprogramtoenableinvestigationaltreatmentsforcovid19 AT jamieracklyeft adaptinganexpandedaccessprogramtoenableinvestigationaltreatmentsforcovid19 AT kevinweatherwax adaptinganexpandedaccessprogramtoenableinvestigationaltreatmentsforcovid19 |