Analytics Enable Post-Hoc Signal Review for Evidence-Based Decision Making
In a critical Phase II neurology trial, a pharmaceutical sponsor faced a challenging R&D decision when efficacy signals showed contradictory results between site and central raters for key clinical outcome assessments, including the primary endpoint.
This complex situation created significant uncertainty around the true treatment effect, making go/no-go pipeline decisions extremely difficult when site rater data suggested treatment-placebo separation, while central rater assessments failed to demonstrate this effect.
The solution? Signant's PureSignal Analytics performed a comprehensive post-hoc analysis to investigate the source of discrepancies across 20+ sites and 90+ patients, utilizing proprietary algorithms specifically tailored to study endpoints.
The results? Evidence-based insights that identified scoring patterns, inter-rater variability, and site-level trends explaining the contradictory findings, enabling confident decision-making for the drug development program.
The approach also helped validate the use of specialized analytics in resolving complex efficacy signal discrepancies, proving that data-driven investigation can transform uncertain trial outcomes into actionable development insights.
Discover how Signant's PureSignal Analytics solution delivered detailed investigation of contradictory findings, provided evidence-based decision support, and enabled sponsors to make confident go/no-go determinations even when faced with conflicting efficacy signals.
