The successful set-up of the Interactive Response Technology (IRT) is critical to ensure subjects in clinical trials are randomised correctly and receive the correct drug, while maintaining study blinding and data integrity. A poorly configured IRT system can lead to unblinding, incorrect drug dispensation, protocol deviation and even regulatory non-compliance.

This case study highlights how ICON rigorously validated an IRT system for a mid-sized biotechnology sponsor before deployment, identifying and mitigating over 100 critical risks. The sponsor lacked in-house expertise in IRT systems to conduct user acceptance testing and partnered with ICON from the outset to align testing with key study milestones and ensure timely execution.

By reviewing the user requirements specification (URS), developing comprehensive user acceptance testing (UAT) scripts, and executing expert-level testing, the team helped prevent potential catastrophic trial failures and ensured seamless system functionality.

A poorly designed IRT system can compromise trial integrity and patient safety.
Common issues include:

URS misalignment with the protocol

• This can lead to risk of protocol deviations, such as incorrect visit scheduling or dosing outside of pre-defined windows

Unblinding risks

• Data visibility in reports and system notifications could inadvertently reveal treatment assignments to site or study staff

Drug dispensing errors

• Subjects may receive incorrect medication due to system logic flows

Randomisation failures

• Incorrect algorithms or systems malfunctions could lead to subjects being randomised incorrectly

For the sponsor, these risks could translate to delayed timelines, protocol violations, regulatory audits and costly
system rework.

ICON’s UAT Solutions team played a critical role in identifying and resolving these risks before go-live, ensuring a seamless IRT deployment, through:

Comprehensive URS review

• Identified misalignments with the protocol, including incorrect visit schedules and medication checks that led to a visible difference in the treatment of subjects on different treatment arms
• Flagged risks of unblinding due to system generated reports and data inconsistencies
• Recommended corrections to user access levels to prevent unauthorised data visibility

Robust UAT script development

• Designed rigorous test scripts with an independent, unbiased approach to ensure full system coverage
• Focused on high-risk areas including complex and customised functionalities

Expert execution of UAT

• Conducted testing through the lens of an end user, ensuring real-world usability
• Collaborated closely with the vendor to retest and validate corrections, ensuring all issues were resolved before deployment

The UAT execution uncovered over 100 issues before system go-live, preventing potential trial failures.

The findings included:

• 15 major findings, including mis-dispensation and unblinding risks that could have compromised trial integrity
• 20 findings required an update to the URS, ensuring alignment with the protocol requirements
• 40 findings required an update to the system to correct logic errors and prevent critical failures
• 10 findings required both URS and system updates, showcasing the need for rigorous UAT

The remainder of the findings were observations of the core system that did not require a resolution during UAT.

Following the proactive measures taken by the ICON UAT Solutions team, the sponsor successfully deployed their IRT system without further issues, ensuring trial integrity, compliance and patient safety.