Cargando…

National landscape assessment of academic medical center support for expanded access to investigational products

Expanded access (EA) provides a pathway for the clinical use of investigational products (drugs, biologics, and medical devices) for patients who are without satisfactory therapeutic options and for whom a clinical trial is not available. Academic medical centers (AMCs) are likely to encounter EA re...

Descripción completa

Detalles Bibliográficos
Autores principales: Gravelin, Misty, Adamo, Joan E., Ellison, Sharon, Segear, Erika, Parrish, Amanda B., Deeter, Christine, Hamill, Jennifer, Rigan, Laurie, Mashour, George A., Weatherwax, Kevin J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cambridge University Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9879891/
https://www.ncbi.nlm.nih.gov/pubmed/36755539
http://dx.doi.org/10.1017/cts.2022.494
_version_ 1784878789404131328
author Gravelin, Misty
Adamo, Joan E.
Ellison, Sharon
Segear, Erika
Parrish, Amanda B.
Deeter, Christine
Hamill, Jennifer
Rigan, Laurie
Mashour, George A.
Weatherwax, Kevin J.
author_facet Gravelin, Misty
Adamo, Joan E.
Ellison, Sharon
Segear, Erika
Parrish, Amanda B.
Deeter, Christine
Hamill, Jennifer
Rigan, Laurie
Mashour, George A.
Weatherwax, Kevin J.
author_sort Gravelin, Misty
collection PubMed
description Expanded access (EA) provides a pathway for the clinical use of investigational products (drugs, biologics, and medical devices) for patients who are without satisfactory therapeutic options and for whom a clinical trial is not available. Academic medical centers (AMCs) are likely to encounter EA requests, but it is unknown what support is available at these institutions for physicians seeking EA for patients. Methods: A landscape assessment was conducted at AMCs, focused on those within the Clinical and Translational Science Awards (CTSA) consortium. Results: Forty-seven responses were evaluated including 42 CTSA hubs. The large majority (43 of 47 respondents) reported using single-patient EA, while 37 reported multi-patient industry sponsored EA and 37 reported multi-patient investigator-initiated EA. Only half reported central tracking of EA requests. Support was available at 89% of sites for single-patient EA but less often for multi-patient EA. Types of support varied and were focused largely on the initial submission to the FDA. Conclusion: Use of and support for EA is widespread at AMCs, with support focused on single-patient requests. Gaps in support are common for activities after initial submission, such as FDA reporting and data collection.
format Online
Article
Text
id pubmed-9879891
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Cambridge University Press
record_format MEDLINE/PubMed
spelling pubmed-98798912023-02-07 National landscape assessment of academic medical center support for expanded access to investigational products Gravelin, Misty Adamo, Joan E. Ellison, Sharon Segear, Erika Parrish, Amanda B. Deeter, Christine Hamill, Jennifer Rigan, Laurie Mashour, George A. Weatherwax, Kevin J. J Clin Transl Sci Special Communications Expanded access (EA) provides a pathway for the clinical use of investigational products (drugs, biologics, and medical devices) for patients who are without satisfactory therapeutic options and for whom a clinical trial is not available. Academic medical centers (AMCs) are likely to encounter EA requests, but it is unknown what support is available at these institutions for physicians seeking EA for patients. Methods: A landscape assessment was conducted at AMCs, focused on those within the Clinical and Translational Science Awards (CTSA) consortium. Results: Forty-seven responses were evaluated including 42 CTSA hubs. The large majority (43 of 47 respondents) reported using single-patient EA, while 37 reported multi-patient industry sponsored EA and 37 reported multi-patient investigator-initiated EA. Only half reported central tracking of EA requests. Support was available at 89% of sites for single-patient EA but less often for multi-patient EA. Types of support varied and were focused largely on the initial submission to the FDA. Conclusion: Use of and support for EA is widespread at AMCs, with support focused on single-patient requests. Gaps in support are common for activities after initial submission, such as FDA reporting and data collection. Cambridge University Press 2022-11-16 /pmc/articles/PMC9879891/ /pubmed/36755539 http://dx.doi.org/10.1017/cts.2022.494 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution and reproduction, provided the original article is properly cited.
spellingShingle Special Communications
Gravelin, Misty
Adamo, Joan E.
Ellison, Sharon
Segear, Erika
Parrish, Amanda B.
Deeter, Christine
Hamill, Jennifer
Rigan, Laurie
Mashour, George A.
Weatherwax, Kevin J.
National landscape assessment of academic medical center support for expanded access to investigational products
title National landscape assessment of academic medical center support for expanded access to investigational products
title_full National landscape assessment of academic medical center support for expanded access to investigational products
title_fullStr National landscape assessment of academic medical center support for expanded access to investigational products
title_full_unstemmed National landscape assessment of academic medical center support for expanded access to investigational products
title_short National landscape assessment of academic medical center support for expanded access to investigational products
title_sort national landscape assessment of academic medical center support for expanded access to investigational products
topic Special Communications
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9879891/
https://www.ncbi.nlm.nih.gov/pubmed/36755539
http://dx.doi.org/10.1017/cts.2022.494
work_keys_str_mv AT gravelinmisty nationallandscapeassessmentofacademicmedicalcentersupportforexpandedaccesstoinvestigationalproducts
AT adamojoane nationallandscapeassessmentofacademicmedicalcentersupportforexpandedaccesstoinvestigationalproducts
AT ellisonsharon nationallandscapeassessmentofacademicmedicalcentersupportforexpandedaccesstoinvestigationalproducts
AT segearerika nationallandscapeassessmentofacademicmedicalcentersupportforexpandedaccesstoinvestigationalproducts
AT parrishamandab nationallandscapeassessmentofacademicmedicalcentersupportforexpandedaccesstoinvestigationalproducts
AT deeterchristine nationallandscapeassessmentofacademicmedicalcentersupportforexpandedaccesstoinvestigationalproducts
AT hamilljennifer nationallandscapeassessmentofacademicmedicalcentersupportforexpandedaccesstoinvestigationalproducts
AT riganlaurie nationallandscapeassessmentofacademicmedicalcentersupportforexpandedaccesstoinvestigationalproducts
AT mashourgeorgea nationallandscapeassessmentofacademicmedicalcentersupportforexpandedaccesstoinvestigationalproducts
AT weatherwaxkevinj nationallandscapeassessmentofacademicmedicalcentersupportforexpandedaccesstoinvestigationalproducts