RESCUE CASE STUDY : Study Tracking/Reporting Increase
Background
Stiris Research was brought in to rescue a global phase II/III rare disease clinical trial providing project and TMF management, monitoring, and vendor support and then a few months later the COVID-19 pandemic hit. The study had to keep going, but the way it was to be conducted was going to have to adapt.
Challenge
MAINTAIN REAL-TIME STATUS REPORTS on SITES’ PANDEMIC CAPABILITIES
Due to the COVID-19 pandemic and the need to complete this pivotal rare disease population trial, ways to keep the momentum of the trial going had to be identified, so the Sponsor requested increased study tracking/reporting to include a weekly report on all site activity.
Stiris created a tracking system that detailed the site name, location and contact details and what each site was allowing in regard to patient visits, as well as, whether enrollment was open for existing/new studies, and whether CRAs were permitted on-site for monitoring.
This tracking report was integral in allowing the Sponsor to understand each site’s capabilities, informing the Sponsor’s decisions during COVID, determining the needs and feasibility for remote monitoring, as well as assessing if additional sites needed to be identified and initiated to keep the study on track with regards to enrollment.
This required an increase in communication between the Stiris Clinical Project Associate (CPA) and all of the sites and necessitated that the Stiris team familiarize themselves with all of the COVID-19 guideline updates for each of the institutions.
Solution
RESPONSIVE COLLABORATION and RAPID ADAPTATION
Stiris seamlessly adjusted, listened and collaborated with the Sponsor, understood their pain points, and found solutions.
The sudden upset and resultant delays precipitated by the rapidly-evolving COVID situation, gave the Sponsor the opportunity to review and amend their protocol and, with site feedback, make it COVID-flexible to avoid/reduce data loss.
Stiris supported the Sponsor by reaching out to sites with additional feasibility questions which enabled us to understand how the pandemic was affecting them, learn how they were adjusting, as well as to collect a running list of the additional technologies that were being implemented and utilized at their facilities.
The tracking system created by Stiris and the weekly reporting empowered all the stakeholders and kept everyone informed so that all parties could pivot where needed. Having this constant, in-depth reporting format helped keep the study on track; thus, despite the pandemic, the study was able to hit critical milestones and the Sponsor could ensure all of their decision makers had the information needed to keep the study appropriately budgeted and funded.
This increased and deepened conversation with sites and the Sponsor, allowed Stiris to determine study needs and collaboratively identified new vendors to support study continuity, including direct-to-patient IP delivery, eDiary, and home health care.
Results
- The Stiris PM, CPA and CRAs are strong communicators and exercised their good rapport with sites to identify remote monitoring needs and work efficiently at updating investigational budgets/contracts
- Due to the flexible and scalable nature of Stiris, the project team was able to rapidly evolve to the situation
- Stiris was able to maintain momentum on the study with minimal delays and was able to adjust the study to virtual format
- The Sponsor was able to take information collected by Stiris to ‘COVID-proof’ their protocol to protect against data loss and ensure that the study could open in a timely manner for patients and their caregivers