The use of biomarkers which assist in understanding various therapeutic medical diseases has applications in observational, randomised clinical trials, screening and diagnosis and prognosis of the particular disease. Biomarkers offer the means for homogeneous classification of a disease and risk factors and enhance primary information across the board of underlying pathogenesis of disease. Biomarkers can also reflect the entire spectrum of disease – from the earliest signs to the end stages of the disease process. Christene Leiper of Onorach explores the future of biomarkers in clinical trials.