Zobrazeno 1 - 10
of 21
pro vyhledávání: '"Misty Gravelin"'
Publikováno v:
Journal of Clinical and Translational Science, Vol 8, Pp 55-56 (2024)
OBJECTIVES/GOALS: The objective of this initiative was to promote MICHR staff’s production of Clinical and Translational Science publications. MICHR leadership approved this initiative, including an evaluation plan with measurable outcomes goals, a
Externí odkaz:
https://doaj.org/article/0e8f8fc4ebea4d68b6bd6f957afc2a78
Publikováno v:
Journal of Clinical and Translational Science, Vol 8, Pp 149-150 (2024)
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 Administ
Externí odkaz:
https://doaj.org/article/c9bcbd00a6904a22abbabafec4093467
Autor:
Misty Gravelin, Laurie Rigan, Joan E Adamo, Sharon Ellison, Erika Segear, Amanda Parrish, Christine Deeter, Jennifer Hamill, Erik Soliz, Ahamed Idris, George A Mashour, Kevin J Weatherwax
Publikováno v:
Journal of Clinical and Translational Science, Vol 8, Pp 150-151 (2024)
OBJECTIVES/GOALS: Physicians can request the clinical use of investigational products for their patients through an FDA pathway called Expanded Access (EA). Most evaluations of EA focus on the FDA submission only. We sought to evaluate these requests
Externí odkaz:
https://doaj.org/article/c1256fd7fe614fc9afbe3824224a7daf
Autor:
Misty Gravelin, Joan E Adamo, Sharon Ellison, Erika Segear, Amanda Parrish, Christine Deeter, Jennifer Hamill, Erik Soliz, Ahamed Idris, George A Mashour, Kevin J Weatherwax, Laurie Rigan
Publikováno v:
Journal of Clinical and Translational Science, Vol 8, Pp 152-152 (2024)
OBJECTIVES/GOALS: The FDA allows physicians to request clinical use of investigational drugs, biologics, and devices for patients with no satisfactory treatment options through a pathway called Expanded Access (EA). TEAMSS (Transforming Expanded Acce
Externí odkaz:
https://doaj.org/article/5ef196caa6b34c8b91bb280627074757
Autor:
Misty Gravelin, Joan E. Adamo, Sharon Ellison, Erika Segear, Amanda B. Parrish, Christine Deeter, Jennifer Hamill, Laurie Rigan, George A. Mashour, Kevin J. Weatherwax
Publikováno v:
Journal of Clinical and Translational Science, Vol 7 (2023)
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 me
Externí odkaz:
https://doaj.org/article/0f8891b01794433285895cb2b0fb2ca8
Publikováno v:
Journal of Clinical and Translational Science, Vol 7, Pp 119-119 (2023)
OBJECTIVES/GOALS: Lack of diversity within clinical trials is well known, but there is little data on the use of investigational products through other pathways, such as expanded access. This project sought to determine the demographic diversity of p
Externí odkaz:
https://doaj.org/article/6400bbe514e143428cb6c67400660ef1
Publikováno v:
Journal of Clinical and Translational Science, Vol 6 (2022)
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
Externí odkaz:
https://doaj.org/article/cf1793642b4347b9869280f564c0fd79
Autor:
Misty Gravelin, Jeanne Wright, M.E. Blair Holbein, Marlene Berro, Jennifer S. Brown, George A. Mashour, Kevin J. Weatherwax
Publikováno v:
Journal of Clinical and Translational Science, Vol 5 (2021)
Abstract Introduction: With no approved treatments for COVID-19 initially available, the Food and Drug Administration utilized multiple preapproval pathways to provide access to investigational agents and/or medical devices: Expanded Access, Emergen
Externí odkaz:
https://doaj.org/article/1230133a4dd1470c8f796da359c760e4
Autor:
M. E. Blair Holbein, Kevin J. Weatherwax, Misty Gravelin, Raymond Hutchinson, George A. Mashour
Publikováno v:
Journal of Clinical and Translational Science, Vol 2, Pp 115-117 (2018)
Externí odkaz:
https://doaj.org/article/96dae814ae954fc6ab9667303a413125
Publikováno v:
Journal of Clinical and Translational Science, Vol 2, Pp 85-85 (2018)
OBJECTIVES/SPECIFIC AIMS: There is no consensus on what constitutes translational research. To effectively support translation of research into practical settings, universities must determine who is involved, in which disciplines, and what results. I
Externí odkaz:
https://doaj.org/article/5b0646f84a1a4ff5a82c7de29ce269dd