Case Study: LG Chem achieves balanced, reliable randomization for complex gout trials with Perceptive's IRT minimization solution

LG Chem Randomization Challenge Resolved by Calyx IRT

LG Chem faced a complex randomization challenge for two gout trials: low recruitment in some strata meant a typical blocked-list design would require an impractically large block size, risk allocation imbalances, potentially exclude treatment arms in small strata, extend timelines and increase cost, and even allow partial unblinding. LG Chem engaged Perceptive to provide IRT/randomization expertise and recommend an alternative RTSM approach.

Perceptive ran simulations and implemented a pre-validated minimization module (Pocock and Simon method with biased-coin assignment) within its IRT, tuning the random element and stratum weights to preserve unpredictability while maintaining balance. The Perceptive solution reduced the risk of allocation imbalance, avoided the need to raise recruitment targets or timelines, and supplied a full audit trail for every assignment—giving LG Chem confidence that the protocol’s complex randomization requirements were met.

LG Chem