Case Study: Optimizing Feasibility and Start-Up for a Phase III HemOnc Clinical Trial - PSI CRO

Case Study: Optimizing Feasibility and Start-Up for a Phase III HemOnc Clinical Trial

At a Glance

No trial is ever easy. But with the continued effects of the global pandemic and the war in Ukraine, the sponsor had larger than average challenges. Nonetheless, PSI managed to demonstrate swift feasibility and start-up ahead of schedule, leveraging site relationships, and fostering team consistency and stability. In the end the study completed enrollment of nearly 900 patients on time at as many as 370 sites all around the world. Italy and Australia showed up as the top enrolling countries.

Patient Enrollment Numbers

Sponsor Challenges

Enrolling over 900 patients and in a clinical trial of this complexity would pose a challenge even in the most mundane of years. Add to that continual pandemic consequences and a global conflict, the stage is set for every possible delay and communication breakdown. The sponsor needed a CRO willing to tackle an aggressive recruitment plan and provide a solid partnership in order for the trial to succeed.

Start-Up in Sync

Staying on time means starting on time. Working closely with sites to understand how the pandemic affected their ability to meet site activation, PSI offered them several technical options that allowed for remote site selection visits. PSI managed to identify over 3000 sites and select about 500 sites 3 months ahead of schedule.

Additionally, feasibility projections were actually reflected in enrollment, not merely a best-case scenario or wishful thinking. This is due in large part to knowing the sites. Today, PSI would have also added machine-learning-powered tool, VISIONAL™, to generate the most optimal enrollment scenarios that could potentially further reduce the study time and cost.

Racalibrating the Geo-mix

Not every CRO can offer flexibility and adaptability, especially in a short amount of time. During enrollment, a change of strategy on the sponsor side called for more sites, and swiftly. In order to do this, countries with initially smaller projected sites and patients had to ramp up with little to no interruption. The only way this could be accomplished was with previously established solid global site relationships and coordination and stellar communication on every level of the study team.

Managing Motivation, Staffing, & Velocity

To motivate teams on a country level, PSI staff focused on maintaining a sense of competition between teams. This helped create a friendly sense of excitement as countries saw their recruitment numbers grow.

Continuity of the study team also played an enormous role in the study’s success. This not only helped keep the study on track when the client had changes to their own staff but provided a sense of consistency and reliability throughout the course of the trial at every level. Key roles project supervisor, project manager and other key staff stayed on for the whole of two years of study duration, something almost unheard of in this ever-changing industry. They are still with PSI running the trial as we write these lines.

The PSI Advantage

For the sixth year in a row, PSI CRO has been named a CRO Leadership Award winner in the categories of Expertise, Quality, and Reliability in the Overall (combined Big and Small pharma) respondent group. The CRO Leadership Awards are presented by Life Sciences Leader and Clinical Leader based on research conducted by ISR Reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.

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