Rescuing a Fledgling Parainfluenza Study and Seeing It Through
In 2019, a large, international Phase III study of a treatment for parainfluenza in immunocompromised subjects was underway in the U.S. Unfortunately the study’s sponsor, a small, U.S.-based biopharmaceutical company, was displeased with the existing CRO’s conduct of the trial. The sponsor asked Westat to take over the study’s management – emphasizing its need for an experienced, responsive, flexible project team that could offer creative solutions to accelerate start-up activities on a short timeline. In reality, the study needed to be rescued.
Rising to the Challenge
Immediately, we selected key senior staff to manage the transition and meet with the sponsor to discuss our detailed transition plan. The strategy included using our cost-effective, integrated web-based system to streamline processes and reduce the burden on both sites and staff.
With project management tools and our proprietary standard operating procedures (SOPs) in place, we accomplished the smooth transfer of multiple subcontractors, study materials, and services in just six weeks. There was minimal impact to the project schedule or budget, little burden to participating sites, and no risk to subjects’ safety.
Engaging the Sites with Innovative Resources
To keep the sites engaged both during and after the transition, and especially during COVID-19 when recruitment was low, we added a clinical trial educator (CTE). The CTE supported communications, identified barriers to enrollment, and reinforced and provided specially focused trainings to clinical site staff and large teams of respiratory therapists.
Identifying Areas for Improvement
To pinpoint areas needing improvement, we conducted a gap analysis of the existing study materials and systems and adapted many of the prior CRO’s templates and project plans to accelerate enrollment. We ensured electronic case report forms were Clinical Data Interchange Standards Consortium (CDISC)-compliant and streamlined for data entry at the site and replaced the existing Interactive Web Response System (IWRS) vendor with one aligned with our high-quality standards. When concerns surfaced, we immediately discussed them with the sponsor.
Delivering a Successful Study
For the European Union (EU) study, 19 sites in six countries had been previously selected, but progress was otherwise at a standstill. We promptly leveraged existing partnerships with regulatory and data protection subcontractors who had solid EU experience and presence. With their expertise and our oversight, we collaboratively worked to progress the study in the EU and within three months were able to begin submitting applications for regulatory approvals.
Featured Project Highlights
Launching an Oncology Trial in the Emerging COVID-19 Pandemic
When a small international company approached Westat in 2020 to conduct a phase I solid tumor study, the World Health Organization had just declared the COVID-19 outbreak as a global pandemic. Aggressive actions to contain the spread of COVID-19 were implemented. People were asked to shelter at home, access to all but the most critical medical procedures was restricted, and hospitals implemented strict policies on entrance and admissions. The challenge was to navigate this environment while simultaneously kicking off a rigorous study protocol.
Expediting an Urgent Sub-study for COVID-19 Treatment
During the global pandemic of 2020, Westat pivoted with urgency to help leverage existing infrastructure from an ongoing influenza study toward a sub-study for a COVID-19 treatment. Despite the challenges posed by the pandemic, our experts successfully implemented remote site monitoring and new safety procedures.
Tenaciously Pursuing Approval for Novel Gene Therapy
Westat rescued a Phase I study in progress with flexibility and creativity that enabled our team to see it all the way through to FDA approval. We are proud to have been a part of bringing a treatment to market to help address an inherited condition that can lead to blindness.