The role of clinical imaging in oncology drug development: progress and new challenges.

In 2008, the role of clinical imaging in oncology drug development was reviewed. The review outlined where imaging was being applied and considered the diverse demands across the phases of drug development. A limited set of imaging techniques was being used, largely based on structural measures of disease evaluated using established response criteria such as response evaluation criteria in solid tumours. Beyond structure, functional tissue imaging such as dynamic contrast-enhanced MRI and metabolic measures using [F]flourodeoxyglucose positron emission tomography were being increasingly incorporated. Specific challenges related to the implementation of imaging were outlined including standardisation of scanning across study centres and consistency of analysis and reporting. More than a decade on the needs of modern drug development are reviewed, how imaging has evolved to support new drug development demands, the potential to translate state-of-the-art methods into routine tools and what is needed to enable the effective use of this broadening clinical trial toolset. In this review, we challenge the clinical and scientific imaging community to help refine existing clinical trial methods and innovate to deliver the next generation of techniques. Strong industry-academic partnerships and pre-competitive opportunities to co-ordinate efforts will ensure imaging technologies maintain a crucial role delivering innovative medicines to treat cancer.