Specialized Analytics Ensure Adherence to Entry Criteria to Drive Signal Detection

In a Phase II mood disorder trial, a pharmaceutical company faced the critical challenge of baseline score inflation and patient eligibility issues that commonly compromise signal detection in psychiatry studies.

This complex situation threatened endpoint data reliability, as mood disorder trials frequently struggle with the inclusion of patients who may not fully meet diagnostic criteria for study entry, significantly impacting study outcomes and the ability to detect true treatment effects.

The solution? Signant's PureSignal Analytics deployed proprietary algorithms to map clinical outcome assessment responses to DSM-5 Major Depressive Episode criteria, enabling continuous monitoring of patient screening patterns across 50 sites and 250+ patients in real-time.

The results? Systematic detection of potential eligibility issues and targeted site interventions that protected endpoint data reliability while maintaining efficient patient recruitment throughout the study.

The approach also helped validate the use of specialized analytics in addressing baseline score inflation, proving that rigorous adherence to entry criteria can be systematically monitored and optimized without compromising recruitment efficiency.

See how Signant's PureSignal Analytics solution enabled continuous monitoring of screening patterns, provided targeted rater- and site-level interventions, and delivered evidence-based protection against baseline inflation risks in this challenging mood disorder trial environment.