Adapting an Expanded Access program to enable investigational treatments for COVID-19.
J Clin Transl Sci
; 6(1): e77, 2022.
Article
in English
| MEDLINE | ID: covidwho-1867969
ABSTRACT
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.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Type of study:
Case report
/
Experimental Studies
/
Observational study
/
Prognostic study
Language:
English
Journal:
J Clin Transl Sci
Year:
2022
Document Type:
Article
Affiliation country:
Cts.2022.403
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