survGenesInterim

survGenesInterim simulates survival studies and analyzes gene expression-based biomarkers to support interim analyses and control false discovery rates in high-dimensional microarray survival experiments.

Key Features:

• Simulation Capabilities: Generates synthetic gene expression data and associated patient information to simulate survival studies for sample size planning and study design evaluation.
• Interim Analysis Support: Performs interim analyses for survival studies while addressing biases from multiple testing.
• False Discovery Rate Control: Maintains pre-specified false discovery rate levels across interim analyses in high-dimensional microarray settings.
• Power Rate Estimation: Implements a novel estimator of average power rates that quantifies the proportion of true positives detected and may slightly deviate from the true power rate while remaining comparable to existing methods.
• Early Stopping Evaluation: Evaluates early stopping criteria based on achieved power rates to determine whether a study can be concluded before its planned endpoint.

Scientific Applications:

• Oncology biomarker discovery: Identifies and validates gene expression biomarkers linked to patient survival in oncology using simulated microarray experiments and interim analyses.
• Study planning and interim decision-making: Supports planning of microarray survival studies, sample size determination, and interim decisions including early stopping based on power and FDR criteria.

Methodology:

Uses a simulation framework that generates synthetic gene expression and patient data for comprehensive sample size planning and study design evaluation, supports analysis of high-dimensional microarray data, controls false discovery rates across interim analyses, and employs an estimator for average power rates.