Overcoming Global Challenges and Meeting Enrollment on a Phase III cUTI Antibiotic Study

At a Glance

Antibiotic development is notoriously underfunded, so running a pivotal phase 3 study can be a challenge. From the beginning, PSI supported the sponsor by leveraging our global site relationships and experience with pivotal antibiotic trials for the most pragmatic site selection. This helped us enroll the trial at a rate 23% higher than industry metrics in the same indication, with Last Patient In (LPI) occurring during the peak of the first COVID-19 wave. It wouldn’t have been possible without our investment in building close site relationships – because our CRAs act as site ambassadors, sites want to work with PSI and prioritize our studies, even in the midst of a pandemic. 

Antibiotic CS enrollment

Phase 3 study in cUTI - Enrolled 23% above industry metrics in the same indication

Sponsor Challenges

Where did anyone see an easy Phase 3 trial lately: timelines slip, vendors get acquired, standards of care change, interest dwindles, competition doesn’t stand still…the list goes on and on.  These studies are meticulous and require a great amount of time and attention.  With a study of this magnitude, ensuring the quality of data globally was also critical.

PSI Strategy

1) Antibiotic Experience

PSI’s strategy for delivering these studies has been tried and tested, ensuring our sponsors the most effective way to deliver antibiotics to market. We also have experience working with BARDA, so we were able to manage the complexities of working with them on this study.

2) The Right Team

PSI invests time and resources to build close site relationships; we empower our CRAs to go further than is typical across the industry. This means sites want to work with PSI, they prioritize our studies, and we understand their preferred methods of working and individual quirks.  

3) Commitment to Quality

The team understood that delivering the data on time was crucial for the study’s success. PSI used a network of regional microbiology labs to ensure the quality of data globally. Despite COVID-19 lockdowns and limited access to sites and patients, our CRAs were able to work closely with site staff to understand each sites individual needs and processes and ensure that all necessary data was collected and cleaned in time to meet key trial milestones.

Results

  • Enrollment rate 23% higher than industry metrics in the same indication 
  • More than 95% of sites enrolling patients 
  • Enrollment of 1,370 patients delivered in 11 months  
  • Screen failure rate of only 5% 

Learn how PSI can support your antibiotic or infectious disease study at the resources below or contact us today

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Infectious Disease Experience

We are an antibiotic powerhouse. 8 out of 12 novel antibiotics approved by the FDA since 2010 used pivotal clinical data generated by PSI sites.

White Paper

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 

Share