RESCUE CASE STUDY: Study Adaptation During a Global Pandemic
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 the ongoing COVID-19 pandemic. However, doing so, required Stiris and the Sponsor to pivot and take into consideration how to effectively initiate sites, which raised concerns about the risks surrounding potential patient loss due to travel restrictions as well as increased potential for patient safety to be compromised when they come in for required study visits.
In order to protect against patient and data loss, the Sponsor revised their protocol to include home healthcare contingency visits, a mobile eDiary app, inclusion of telehealth visits, and expand conduct of the trial in the Australia-New Zealand (ANZ) region.
These changes prompted a major protocol amendment and Stiris supported the Sponsor in launching this protocol in North America and Supporting the expansion to the ANZ region via a CRO alliance.
SOLUTION: RESPONSIVE COLLABORATION and FORWARD-THINKING
Stiris was key in supporting the Sponsor with the rollout of this new protocol and entry into the ANZ region.
Stiris activated their alliance with an Asia-Pacific CRO and helped the Sponsor with next steps on discussions/quotes to start study start-up work in this region. Stiris and the partner CRO were able to quickly organize a kick-off meeting and start collaborating on the trial.
Over the second and third waves of COVID in the US/Canada, Stiris tracked and created weekly reports detailing the current visitor restrictions at each site. Thus, allowing the Sponsor to effectively prioritize sites for launch as well as determine how best to initiate each site respectively – virtual vs. hybrid. Additionally, a tremendous amount of supplies and equipment were needed to conduct this trial. In order to ensure that start-up happened smoothly and run the amended protocol appropriately, Stiris adjusted release of study materials to accommodate possible shipping delays and then tracked each shipment until receipt could be verified.
The Stiris team was in constant contact with the sites – relaying the current challenges and working together at creative solutions to each site’s unique situation while also keeping the study moving forward.
KEY HIGHLIGHTS
- Stiris/Sponsor collaboration and adaptability in conducting the SIV in a novel way rather than cancelling the visit and delaying the study.
- Each Stiris team member worked closely with one another to successfully initiate and activate these sites.
- Site trainings were approached creatively – working to each site’s unique needs and technological capabilities at times where travel and in-person meetings were just not feasible.
- The Stiris philosophy to all work towards the same “why” – Team members are always ready and willing to pick up the phone, talk to the sites and help navigate questions and logistics.
- All projected enrollment targets were met, enabling subjects to enter a second open-label treatment study without delays.