Adapting an Expanded Access program to enable investigational treatments for COVID-19.
Elias M SamuelsEllen ChampagneMisty GravelinJamie RacklyeftKevin J WeatherwaxPublished in: Journal of clinical and translational science (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 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.
Keyphrases
- quality improvement
- public health
- sars cov
- healthcare
- coronavirus disease
- mental health
- palliative care
- electronic health record
- cross sectional
- primary care
- big data
- health information
- randomized controlled trial
- social media
- emergency department
- physical activity
- health promotion
- current status
- deep learning
- risk assessment
- respiratory syndrome coronavirus
- human health
- pain management
- drug induced
- chronic pain
- affordable care act