UBC was contracted to provide clinical trial nursing services in a pivotal Phase III autoimmune rare disease clinical trial. As this indication affects less than 2% of the population, ensuring that enrolled patients completed study requirements without loss-to-follow-up was crucial. The study was designed to assess the efficacy and safety of the study drug compared with placebo in adults who had been receiving the study drug via a separate open-label trial.
Patients enrolled in the open-label trial who consented to be enrolled in the Phase III trial were flown to one of two locations and housed at a hotel in close proximity to the study site. The protocol required a separate nurse (outside of the study site) to visit the patient and provide an overview of the study requirements, obtain lab samples and check on the overall health of the patient outside of site visits. Additionally, the designated hotel was to provide 24/7 supplementary emergency health care services.
Challenge or Situation:
The UBC nurse coordinator (NC) received a phone call from the sponsor. The sponsor reported they received their first subject on placebo. The subject experienced immobility and was unable to complete any of their activities of daily living (ADLs). The subject’s caregiver was struggling to provide care for the patient. The designated hotel had stopped providing 24/7 health care services, unbeknownst to the sponsor. The subject was ready to withdraw from the study; desperate to stabilize symptoms by resuming the open-label drug via the separate trial.
The UBC NC identified nursing agencies within the UBC network that could provide 24/7 health care services in conjunction with the assigned home care nurse for the subject for the duration of their stay to facilitate the completion of the remaining study requirements. The sponsor, home care nurse, and NC successfully functioned as a cohesive team to staff the subject with a private duty aide within 45 minutes of the initial phone call from the sponsor.
Outcome: The patient was able to receive the care that was needed to remain on placebo and completed the remaining study requirements. The sponsor did not have to extend the recruitment period, and overall study timelines were not impacted. More importantly, the patient and caregiver needs were addressed, and the intervention positively affected their experience in participating in the trial.
This case study is just one example of the value add to utilizing clinical trial nursing services. Homecare nurses can perform an array of clinical trial activities such as study drug administration and training, blood and other specimen collections, clinical assessments, questionnaires, compliance reviews, data collection, and documentation.
UBC’s Clinical Trial Nursing team provides services in more than 40 countries and has completed 30,000+ clinical interactions in the last year by utilizing our network of more than 2,100 agencies.