At a Glance
When a small biotech approached PSI to run a complex UC study, the sponsor’s concerns were clear: streamline initial set-up, avoid complex vendor management, and overcome multiple operational challenges. PSI was up to the challenge, helping the sponsor achieve 50% enrollment five weeks before their goal and complete enrollment more than five months ahead of schedule.
Phase 2 study in UC - Achieved 50% enrollment five weeks before their goal
Clinical trials are inherently uncertain, and this study highlighted the inevitability of unforeseen challenges more than most. Along with the impact of the COVID-19 pandemic, this sponsor encountered challenges such as poor performance of a central lab, issues with their IP supplies vendor, medical staff turnover, site activation delays due to equipment set-up, and the greatest challenge of all, a major study redesign and update post startup following FDA feedback.
1) Identifying the Perfect Geomix and Ensuring Fast Startup
To ensure fast site startup in the US, PSI identified the central IRB sites with both the right experience and the shortest contract finalization timelines from our database of more than 4,000 global sites. Our Site Qualification Specialists also confirmed sites were properly equipped to use study equipment before the Site Initiation Visit to avoid slowdown during activation. Using VISIONAL™, PSI’s proprietary data-driven feasibility and enrollment forecasting tool, the team identified the best country mix and site profile by collating historical enrollment rates in the given patient population from both internal and external data sources.
2) Invested in Communication
Communication with sites was crucial to enroll patients ahead of schedule. The Study Coordinator organized meetings with each site to discuss the study and each site’s immediate next steps. During the startup process, our CRAs began in-depth training and coaching with all relevant site staff on topics such as best practices for patient consent conversations, raising site awareness, study-specific tasks, and developing a site-specific patient flow to understand the referral process. PSI also developed site-facing enrollment boosting materials and contacted sites weekly to maintain investigator motivation, track screening and enrollment, and investigate any challenges with low enrollment.
3) Next-Level Site Support
Dedicated to building site relationships and understanding the dynamics of each site at the local level, PSI’s Site Support Specialists ensured that each site was supported and had the resources necessary to enroll patients effectively and maximize protocol compliance. The team developed and maintained communication pathways between the combination of physicians/departments, lab specialists, and nurses to facilitate the smooth flow of referrals, and utilized a suite of proprietary PSI tools to ensure sites understood individual stakeholder responsibilities and key study strategies.
With the help of our CRAs, site support specialists, and other team members, PSI closed screening due to high volume even while sites had additional patients. We achieved 50% of the enrollment goal five weeks before the sponsor’s goal and completed enrollment more than five months ahead of schedule. The team also worked closely with investigators to ensure activation timelines were met, helping us achieve the first site activation in just 3.5 months.
As the need for clinical trials in Crohn’s disease and ulcerative colitis grows, partnering with the right CRO matters more than ever. 100% of PSI’s GI and IBD studies have enrolled on time or ahead of schedule.
Are Your CRO’s Site Relationships Helping or Harming Your Clinical Trial? Solid site relationships are the backbone of successful clinical trials. Without happy, supported sites, enrollment simply cannot happen predictably or within budgetary constraints