In cancer drug development, data extracted from medical images are used as surrogate endpoints to determine the efficacy of new drug and innovative therapeutic schemes.
Oncology is the most important therapeutic area in terms of drug industry R&D expenses and represents about 38% of the clinical trials market. In parallel, oncology faces the highest attrition rate among all therapeutic areas, with a huge number of abandonment in late phases, causing substantial financial losses for pharmaceutical companies.
Today, images are used as surrogate endpoints in cancer drug development but their prominent role triggers new clinical and technological challenges: image interpretation should be objective, quantitative and with a low variability, image losses should be prevented.
Images accompany patients in their cancer care and provide valuable personalized information on their treatment effectiveness. Imaging biomarkers provide unparallel information about disease status and evolution.
Images play a pivotal role in cancer care to evaluate the patient response to therapy. Image interpretation and imaging biomarkers assessment provide major information about disease status and evolution over therapeutic cycles. They enable to adapt treatment options offered to the patient, and contribute to the emergence of a personalized and evidence-based medicine, today the reference in oncology.
Nevertheless, medical images interpretation remains subjective; in 30% of cases, two radiologists will have a different interpretation for the same images, with an obvious impact on treatment response evaluation of the patient involved and his care pathway. In order to optimize patient treatments, images must be interpreted in a accurate, objective and reliable manner.
In the near future, new imaging companion tests will evaluate cancer treatment effectiveness in practice on large scale patient population.
Regulatory bodies such as EMA and FDA first, as well as private insurers and cancer patient advocacy groups, are increasingly vigilant about treatment effectiveness evidence. They do not hesitate to re-investigate the risk-benefit balance as well as the cost-benefit of already marketed drugs.
Within this context, definition and use of new imaging companion tests will enable to better qualify benefits related to treatments non-invasively and at low costs. This approach will benefit above all patients and their relatives, but also the insured persons because enabling a better use of funds invested in healthcare coverage. The best-performing pharmaceutical companies will demonstrate their treatments are not only innovative, but also extremely efficient.