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Controlled clinical trials (CCTs) have traditionally been limited to urban academic clinical centers. Implementation of CCTs in rural setting is challenged by lack of resources, the inexperience of patient care team members in CCT conductance and workflow interruption, and global inexperience with remote data monitoring.
We report our experience during the coronavirus disease 2019 (COVID-19) pandemic in activating through remote monitoring a multicenter clinical trial (the Study of Efficacy and Safety of Canakinumab Treatment for cytokine release syndrome (CRS) in Participants with COVID-19-induced Pneumonia [CAN-COVID] trial, ClinicalTrials.gov Identifier: NCT04362813) at a rural satellite hospital, the VCU Health Community Memorial Hospital (VCU-CMH) in South Hill, VA, that is part of the larger VCU Health network, with the lead institution being VCU Health Medical College of Virginia Hospital (VCU-MCV), Richmond, VA. We used the local resources at the facility and remote guidance and oversight from the VCU-MCV resources using a closed-loop communication network. Investigational pharmacy, pathology, and nursing were essential to operate the work in coordination with the lead institution.
Fifty-one patients with COVID-19 were enrolled from May to August 2020, 35 (69%) at VCU-MCV, and 16 (31%) at VCU-CMH. Among the patients enrolled at VCU-CMH, 37.5% were female, 62.5% Black, and had a median age of 60 (interquartile range 56–68) years.
Local decentralization of this trial in our experience gave rural patients access to a novel treatment and also accelerated enrollment and more diverse participants’ representative of the target population.
This chapter talks about a 45-year-old right-handed woman who was admitted to a Neurology clinic with several years of cognitive difficulty. She has a long-standing history of depression, which has been fairly well-controlled on sertraline 100mg daily. There are no other chronic medical problems or regular medications. CT of the head demonstrated very mild generalized atrophy with more pronounced atrophy of the head of the caudate nucleus. The initial diagnostic impression was Huntington disease, despite the lack of a clear family history. Genetic testing was performed, which demonstrated an expansion of the CAG repeat region in the huntingtin gene on chromosome 4. Additionally, a more thorough family history revealed that her father and several of his relatives had involuntary movements. Huntington disease (HD) is a neurodegenerative disease characterized clinically by the triad of a movement disorder, dementia, and behavioral disturbances.