Abstract

Biomarkers play a pivotal role in modern drug development by providing critical insights into disease mechanisms, patient stratification, and therapeutic efficacy. This review examines the evolving landscape of biomarkers, highlighting their utility in transforming clinical trials through enhanced patient selection, optimized dosing regimens, and real-time monitoring of treatment responses. The integration of biomarkers in clinical trials not only accelerates the drug approval process but also improves the likelihood of successful outcomes by enabling more precise and personalized therapeutic strategies. Furthermore, we discuss the challenges associated with biomarker validation and implementation, as well as future directions for research aimed at expanding the application of biomarkers in diverse therapeutic areas. This comprehensive understanding of biomarkers will ultimately enhance the drug development pipeline, leading to more effective and safer treatments for patients.