Experimental Design, Randomisation, and Validation: Foundations for Reliable Biomarker Discovery

This review addresses the critical methodological principles underlying reproducible biomarker and omics research, including proper experimental design, randomisation strategies, and validation frameworks. Poor study design has been a recurring source of irreproducible results in high-throughput clinical studies. Rigorous attention to these fundamentals is essential for any mass spectrometry or omics-based discovery programme aiming for clinical translation.