BioPETsurv

BioPETsurv evaluates prognostic enrichment biomarkers for time-to-event clinical trials by analyzing biomarker and censored survival data and simulating trial scenarios to inform trial design.

Key Features:

• Biomarker Evaluation: Analyzes candidate biomarkers alongside potentially censored survival times to assess prognostic enrichment potential for time-to-event endpoints such as patient survival.
• Trial Planning and Simulation: Simulates clinical trial scenarios matching specified settings to evaluate the effects of prognostic enrichment strategies on trial outcomes.
• Quantitative Analysis: Estimates trial metrics including sample size, patient screening requirements, total patient screening cost, and per-patient trial expenses to quantify the impact of prognostic enrichment.

Scientific Applications:

• Oncology trial design: Identifies patients at higher risk of events such as disease progression or death to inform prognostic enrichment in oncology time-to-event trials.
• Time-to-event clinical research: Applies to other clinical fields with time-to-event outcomes to improve trial efficiency and resource allocation by focusing on higher-risk populations.

Methodology:

Performs empirical analysis of real-world biomarker and survival-time data (including censored observations) and uses simulation to generate hypothetical datasets that mirror specified clinical scenarios.