Biomarker Prognostic Enrichment Tool

Prognostic Enrichment (Temple, 2010; PMID 20944560) is a clinical trial strategy of evaluating an intervention in a patient population with a higher rate of an unwanted clinical event than the broader patient population. A higher event rate in an enriched study population translates to a lower sample size for the clinical trial. This can have both practical and ethical advantages.

Our methodology evaluates biomarkers for prognostic enrichment of clinical trials. Using information about the biomarker(s) and clinical trial design, our methods calculate clinical trial metrics (event rate, sample size, cost, etc) for different levels of enrichment.

Our methodology is implemented as two webtools: BioPET evaluates biomarkers for trials with dichotomous/binary outcomes; BioPETsurv is for trials with survival/time-to-event outcomes.


Acknowledgement

This work was supported by NIH grant R01085757 (http://tribe.jhmi.edu/)