What makes a good biomarker?

The last decade has seen an extraordinary amount of effort devoted in biomedical research to the field of biomarkers. There have been some notable successes with novel markers being adopted into clinical practice bringing clear clinical benefit to some patients — particularly with the increasing numbers of medicines being approved with companion diagnostics. However, it is fair to say that there has not yet been the numbers of clinically valuable biomarkers brought to medical practice that the research effort would seem to warrant. This paper evaluates examples of successful biomarkers, markers which might be considered partial successes and a few problematic examples and argues that more effort spent in the validation phase of marker development, and less in the discovery phase might be a more efficient way to allocate research resources.