A Data-Driven, Targeted Site Selection Strategy Can Accelerate Cell And Gene Therapy Trials

By Angela Hirst, Director, Site Alliance, Therapeutic Networks, Oncology

The article explores the expansion of cell and gene therapy (CAGT) clinical trials beyond traditional academic centers, addressing challenges such as resource constraints and staffing shortages exacerbated by the pandemic. It highlights the strategic involvement of community-based, non-academic hospitals and clinics in conducting CAGT trials, despite their inherent complexity and resource demands. The motivation of principal investigators (PIs) at these sites is crucial for trial success.

Parexel employs a targeted site selection strategy, aligning trial protocols with site capabilities, including genetic testing resources, trial phase preferences, and previous CAGT experience. This approach aims to integrate both academic and community sites, thereby accelerating trial initiation and completion. By leveraging community sites capable of commencing trials within three months, Parexel seeks to expedite the clinical trial process, reducing wait times and costs for patients and sponsors. The organization's commitment to enhancing patient access to treatments involves profiling and pre-screening sites for CAGT research. Through refined site selection methodologies, Parexel aims to deliver therapeutic benefits more swiftly to a diverse patient population, ultimately improving the efficiency and reach of CAGT clinical trials.