Predictive enrichment using biomarkers in studies of critically-ill patients with sepsis: a systematic review
Authors' conclusion
Although the studies were heterogeneous in design and limited in number, those that employed biomarker-based enrichment strategies demonstrate a promising signal for enhanced clinical trial efficiency.
Study context
- Population
- Randomized controlled trials (RCTs) enrolling adults with sepsis that used molecular biomarkers for predictive enrichment12 studies
- Outcome
- Use of biomarkers for predictive enrichment and trial outcomes
Methodological detailsPRISMA-ScR, narrative synthesis without statistical pooling, Cochrane Risk of Bias tool
- PRISMA-ScR
- Narrative synthesis without statistical pooling
- Cochrane Risk of Bias tool
Pooled result
As reported in the abstract
- Studies included (of 1,718 citations)
- 12
- Studies with statistically significant impact on the primary outcome
- Five studies (42%)
- Patient-important benefit (reduced mortality or disease severity)
- three
- Improvement in biomarker-related surrogate outcomes
- two
Original publication
Predictive enrichment using biomarkers in studies of critically-ill patients with sepsis: a systematic review. Crit Care. Published 27 November 2025. doi:10.
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