Translating innovation in biomedical research: Design and delivery of a competency-based regulatory science course
As the pace of biomedical innovation rapidly evolves, there is a need to train researchers to understand regulatory science challenges associated with clinical translation. We describe a pilot course aimed at addressing this need delivered jointly through the Mayo Clinic Center for Clinical and Tran...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2020-02-01
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| Series: | Journal of Clinical and Translational Science |
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| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866119004321/type/journal_article |
| _version_ | 1811156871222919168 |
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| author | Alexandra J. Greenberg-Worisek Katherine E. Cornelius Luz Cumba Garcia Felicity T. Enders Nilay D. Shah Anthony J. Windebank |
| author_facet | Alexandra J. Greenberg-Worisek Katherine E. Cornelius Luz Cumba Garcia Felicity T. Enders Nilay D. Shah Anthony J. Windebank |
| author_sort | Alexandra J. Greenberg-Worisek |
| collection | DOAJ |
| description | As the pace of biomedical innovation rapidly evolves, there is a need to train researchers to understand regulatory science challenges associated with clinical translation. We describe a pilot course aimed at addressing this need delivered jointly through the Mayo Clinic Center for Clinical and Translational Science and the Yale-Mayo Center for Excellence in Regulatory Science and Innovation. Course design was informed by the Association for Clinical and Translational Science’s Regulatory Science Working Group’s competencies. The course used didactic, case-, and problem-based learning sessions to expose students to regulatory science concepts. Course evaluation focused on student satisfaction and learning. A total of 25 students enrolled in the first two course deliveries. Students represented several disciplines and career stages, from predoctoral to faculty. Students reported learning “an incredible amount” (7/19, 36.8%) or “a lot” (9/19, 47.4%); this was reflected in individual coursework and their course evaluations. Qualitative feedback indicated that assignments that challenged them to apply the content to their own research were appreciated. The heterogeneity of students enrolled, coupled with assessments and course evaluations, supports the statement that there is a growing need and desire for regulatory science-focused curricula. Future research will determine the long-term impact. |
| first_indexed | 2024-04-10T04:57:16Z |
| format | Article |
| id | doaj.art-a7fd22d72ee949f694c431165f72b77c |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-04-10T04:57:16Z |
| publishDate | 2020-02-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-a7fd22d72ee949f694c431165f72b77c2023-03-09T12:29:53ZengCambridge University PressJournal of Clinical and Translational Science2059-86612020-02-01481510.1017/cts.2019.432Translating innovation in biomedical research: Design and delivery of a competency-based regulatory science courseAlexandra J. Greenberg-Worisek0https://orcid.org/0000-0001-5935-3239Katherine E. Cornelius1Luz Cumba Garcia2Felicity T. Enders3Nilay D. Shah4Anthony J. Windebank5Center for Clinical and Translational Science, Mayo Clinic, Rochester, MN, USA Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA Yale-Mayo Center for Excellence in Regulatory Science and Innovation, Mayo Clinic, Rochester, MN, USA Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic, Rochester, MN, USACenter for Clinical and Translational Science, Mayo Clinic, Rochester, MN, USAMayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic, Rochester, MN, USACenter for Clinical and Translational Science, Mayo Clinic, Rochester, MN, USA Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic, Rochester, MN, USADepartment of Health Sciences Research, Mayo Clinic, Rochester, MN, USA Yale-Mayo Center for Excellence in Regulatory Science and Innovation, Mayo Clinic, Rochester, MN, USACenter for Clinical and Translational Science, Mayo Clinic, Rochester, MN, USA Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic, Rochester, MN, USAAs the pace of biomedical innovation rapidly evolves, there is a need to train researchers to understand regulatory science challenges associated with clinical translation. We describe a pilot course aimed at addressing this need delivered jointly through the Mayo Clinic Center for Clinical and Translational Science and the Yale-Mayo Center for Excellence in Regulatory Science and Innovation. Course design was informed by the Association for Clinical and Translational Science’s Regulatory Science Working Group’s competencies. The course used didactic, case-, and problem-based learning sessions to expose students to regulatory science concepts. Course evaluation focused on student satisfaction and learning. A total of 25 students enrolled in the first two course deliveries. Students represented several disciplines and career stages, from predoctoral to faculty. Students reported learning “an incredible amount” (7/19, 36.8%) or “a lot” (9/19, 47.4%); this was reflected in individual coursework and their course evaluations. Qualitative feedback indicated that assignments that challenged them to apply the content to their own research were appreciated. The heterogeneity of students enrolled, coupled with assessments and course evaluations, supports the statement that there is a growing need and desire for regulatory science-focused curricula. Future research will determine the long-term impact.https://www.cambridge.org/core/product/identifier/S2059866119004321/type/journal_articleRegulatory sciencetranslational sciencegraduate biomedical research educationFDA |
| spellingShingle | Alexandra J. Greenberg-Worisek Katherine E. Cornelius Luz Cumba Garcia Felicity T. Enders Nilay D. Shah Anthony J. Windebank Translating innovation in biomedical research: Design and delivery of a competency-based regulatory science course Journal of Clinical and Translational Science Regulatory science translational science graduate biomedical research education FDA |
| title | Translating innovation in biomedical research: Design and delivery of a competency-based regulatory science course |
| title_full | Translating innovation in biomedical research: Design and delivery of a competency-based regulatory science course |
| title_fullStr | Translating innovation in biomedical research: Design and delivery of a competency-based regulatory science course |
| title_full_unstemmed | Translating innovation in biomedical research: Design and delivery of a competency-based regulatory science course |
| title_short | Translating innovation in biomedical research: Design and delivery of a competency-based regulatory science course |
| title_sort | translating innovation in biomedical research design and delivery of a competency based regulatory science course |
| topic | Regulatory science translational science graduate biomedical research education FDA |
| url | https://www.cambridge.org/core/product/identifier/S2059866119004321/type/journal_article |
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