Personalized medicine: challenges in biomarker-related clinical trial design

• DOI: 10.4155/cli.14.123
• Publication Date: 2015-02-13T15:01:19Z
• Authors: Pei He
• Keywords: Personalized Medicine

Personalized medicine becomes an area of great interest following the recent development in human genetics, proteomics and metabolomics. There is increasing need to embed scientific discoveries from basic medical research into real life clinical practices, such that a patient's biological traits can be used facilitate treatment. Those individualized traits, termed as biomarkers, are actively involved developing personalized therefore bring out challenges trial designs. The necessity biomarker validation patient subgroup selection make design more complex. This paper will first introduce different types biomarkers then review with clinical, statistical regulatory perspectives.