RESCUE CASE STUDY : Creation and Execution of Hybrid Study Initiation Visit
Background
Stiris Research was awarded the rescue work for a global phase II/III rare disease clinical trial providing project and TMF management, monitoring, and vendor support only to then have to navigate the COVID-19 pandemic. The Sponsor had to keep the study moving forward, but the way it was to be conducted was going to have to adapt.
Challenge
LAUNCH A RARE DISEASE TRIAL IN THE MIDDLE OF A PANDEMIC
Due to the need for this pivotal trial within this rare disease population as well as internal company milestones, the Sponsor wanted to launch the study despite being in the middle of the COVID-19 pandemic.
The requirements of this study design necessitated an onsite Study Initiation Visit (SIV) in order to facilitate training on equipment, tour the site’s facilities, and train the site’s team. The qualification visit was performed by the Sponsor just prior to the pandemic, but the SIV was imperative as the site/PI was new to both the project and Sponsor/Stiris Research.
The CRA scheduled a 2-day visit with the site for December 2020: the first day was to be in person, the second virtual. As time passed and the visit grew closer, the second wave of the pandemic grew more intense and the site’s COVID restrictions tightening, forcing the SIV to be either cancelled or modified to be conducted as virtually as possible.
The new restrictions meant that:
- Only one Sponsor representative allowed on site per hospital COVID restrictions
- PPE equipment was needed for Stiris CRA (Sponsor shipped the CRA an N95)
- Scheduled time on site to be limited and tours were minimized
These restrictions resulted in very limited face-to-face time with site personnel for SIV tasks including demonstrating the study’s physiotherapy equipment.
With the use of technology, additional hurdles presented themselves:
- Most of the SIV was done virtually, and some site team members could not use cameras
- Technical glitches with zoom – Sponsor was unable to play an IP preparation video over zoom
- Difficult to build site relations – SIVs are usually a great opportunity to get to know the Team
- No access to lab kits – CRA could not inventory them (this is usually done)
Solution
RESPONSIVE COLLABORATION, RAPID ADAPTATION and RESILIENCY
Stiris/Sponsor combined collaboration and flexibility to define a novel way to conduct the SIV in the ever-changing COVID landscape so that the SIV could still occur rather than cancelling the visit.
The CRA was able to confirm key site areas while on site (pharmacy, imaging, etc.) as well as demonstrate the use of some of the physiotherapy equipment during their limited time on-site. The remainder of the training and SIV requirements were accomplished via a series of virtual sessions including training with the eDiary vendor, screensharing for neuropsych assessment trainings, and additional meetings to inventory lab kits and review study supplies. SIV attendance logs were issued for each virtual session.
The result was that the site was successfully initiated via a hybrid SIV approach over 2 days.
When there was an additional delay in site activation post-SIV to start screening, the Stiris team held an additional protocol refresher call with the site to ensure that the site’s team were confident that they were up-to-date, familiar, and comfortable with the study design prior to recruitment.
Results
- Stiris/Sponsor collaboration and adaptability in conducting the SIV in a novel way rather than cancelling the visit
- Flexibility with change/adaptability, resilience, experience with rescue studies, fortitude and professionalism of the CRA to travel during the pandemic, CPA who was ready and available to assist with tech support issues during SIV and readily assist in any questions related to vendors and ancillary supplies.
- Stiris was able to maintain momentum on the study with minimal delays and was able to adjust the study to virtual format.
- Successful initiation of a Children’s’ hospital site for a rare disease study in a therapeutic area that no other Sponsors are pursuing at this time.