The role of clinical imaging in oncological drug development.

Clinical imaging has the potential to provide key biomarkers to inform decision-making in drug development. There is considerable optimism that emerging functional imaging techniques will substantially add to the conventional morphological depiction of disease. The discovery, development and qualification of clinical imaging biomarkers remain a considerable undertaking. Once an imaging biomarker is developed, it must be implemented with a high degree of consistency to ensure the collection of robust clinical trial data. The aim of such a development and implementation process is to deliver sufficient confidence in an imaging biomarker to support "go/no-go" decisions made in a drug development programme. This article outlines the drug development process, with a focus on the current impact of clinical imaging on drug development and its probable future direction.