Imaging in clinical trials.

Drug development continues to face challenges to successfully progress the most promising drug candidates through the stages of clinical trials. Given the increasing cost to develop a drug, methods are required to characterise early drug efficacy and safety. Imaging techniques are increasingly used in oncological clinical trials to provide evidence for decision making. With the application of conventional morphological imaging techniques and standardised response criteria based on tumour size measurements, imaging continues to be used to define key study end points. However, functional imaging techniques are likely to play an important role in the evaluation of novel therapeutics, although how these methods are to be optimally applied has yet to be clearly established. The specific challenges of standardising multi-centre imaging in the context of clinical trials are highlighted, including the processes for image acquisition, data analysis and radiological review.