Case Study 3

When a sponsor running a Phase 2 infectious disease study enlisted TruTechnologies to ensure protocol compliance during critical screening visits, they already knew the study would be challenging.

Based on enrollment data from previous, similarly designed studies, the sponsor's expected screen failure rate was set at 75%. The reasoning behind this exceptionally high anticipated screen-fail rate was multifaceted: Not only did the study have incredibly specific inclusion criteria, but determining eligibility also required time-sensitive PBMC samples to be shipped, isolated, and tested off-site, adding another layer of risk.

With the assistance of TruTechnologies' sample management platform, TruLab, however, the actual screen failure rate dropped to 54% – a testament to the power of meticulous study oversight.

Understanding Screen Failure Rates
‍
Screen failure rates can vary significantly depending on various factors such as the type of study, the disease or condition being studied, the inclusion and exclusion criteria, and the target population.

Screen failure rates are also a critical metric in clinical trials, impacting the overall timeline and cost. An unusually high percentage of screen failures is not uncommon, but it highlights the importance of guarding samples, particularly for those patients who do pass the strict requirements.

After all the work to find a patient who passes the strict screening process, it’s not uncommon for that patient to change their mind about participating in a trial. A change of heart can occur for any number of reasons, including:

• Ongoing time required to participate in the trial
• Lost screening samples, requiring redraws by the patient
• And delays in screening sample shipping.

Events

TruLab ensured protocol compliance on the study in two key ways: First, site personnel were provided with step-by-step PBMC sample collection instructions via the TruLab app, including detailed guidance on shipping same-day without the standard on-site centrifugation and aliquoting of samples. TruTechnologies' monitoring team then remotely tracked each visit.

Over the course of a five-week period, the monitoring team intervened in multiple instances involving the handling of PBMC samples collected at screening. Any of these scenarios could have separately ended in the automatic exclusion of the patient regardless of criteria match.

In one instance, the TruTechnologies team noticed that PBMC samples were indeed collected during a screening visit at a California site, but they were not packaged to ship out same-day as per the protocol. Recognizing that this deviation could compromise sample viability, they promptly contacted the site to address the issue.

The study coordinator explained that the samples were unfortunately centrifuged on-site due to an oversight by site staff. However, TruTechnologies’ timely intervention and escalation to the sponsor meant that the participant was able to be rescheduled by the site and brought back in for rescreening just a few days later.

Without this intervention, it could have been weeks before the patient – who did ultimately enroll in the study – was asked to provide another sample, causing them to either fail the screening process at that time or change their mind entirely about participating in the study.

TruTechnologies Prevents PBMC Processing at Site

In another instance, a site coordinator in North Carolina reached out to TruTechnologies with a question about logging samples, which revealed her intention to centrifuge and aliquot the PBMCs prior to shipping. TruLab’s team quickly informed the coordinator that that step wasn’t necessary and instructed the site to ship the samples at ambient temperature in their original collection tubes.

This swift action ensured that this particular patient also wasn’t excluded due to another simple mistake related to the samples.

Conclusion

A 21% improvement between expected and actual screen failure rate was a major win for the sponsor and shows just how critical it is for sites to stick to the study protocol.

Because of TruTechnologies’ platform and monitoring team:
• Multiple protocol deviations were detected and escalated to the sponsor as they happened, allowing for same-day course correction.
• The overall quality of sample handling and protocol compliance improved across the multi-site study.
• The sponsor was able to complete patient enrollment significantly faster than originally anticipated.

Reducing Screen Failure Rates Through Protocol Compliance

When a sponsor running a Phase 2 infectious disease study enlisted TruTechnologies to ensure protocol compliance during critical screening visits, they already knew the study would be challenging.

TruTechnologies Prevents PBMC Processing at Site