Enrichment, Response Amplification, Separation, and Inclusion: Quantifying Trial Design Trade-offs in SLE with QSP SimPops Modeling

Conference: PAGE

Objective

  • Systemic lupus erythematosus (SLE) trials suffer from equivocal or failed trial outcomes.
  • The objective of this work is to use a quantitative systems pharmacology (QSP) model to establish an analysis framework that characterizes trial outcome trade-offs stemming from disease heterogeneity and entry criteria.
  • This framework aims to improve prediction of treatment response to inform trial design and precision medicine.