EMA’s Approach to Biomarker-Based Trials
EMA’s Approach to Biomarker-Based Trials How EMA Regulates and Supports Biomarker-Based Clinical Trials Biomarker-based clinical trials are transforming drug development by enabling precision medicine, patient stratification, and improved therapeutic outcomes. In the European Union (EU), the European Medicines Agency (EMA) plays a pivotal role in guiding the design, validation, and regulatory acceptance of biomarkers in…