Molecular oncology: what is needed to speed access to innovative therapies in clinical research?

Abstract

A better understanding of the biology of cancer cells has led in the past 20 years to more and more molecular and immunological driven treatment strategies impacting both clinical trials and day-to-day practice. The aim of this review is to describe new approaches to conduct clinical trials in this area to speed up drug development and increase access to innovation for cancer patients. The design of an early phase trial has an impact on its clinical benefit. Trials deriving from a specific biomarker or histologic characteristic (also known as enrichment design) are more likely to demonstrate benefit than trials based on a more conventional design. However, the increase of low incidence cancer molecular subtypes poses a major hurdle in the clinical management and drug development research for cancer patients. With the identification of news targets and the subsequent introduction of precision medicine, new strategies and tools are needed to provide access to biomarker identification and target-oriented clinical trials to all cancer patients. We propose to set up a new patient-centered model to conduct clinical trials allowing simply to 'bring the trial to the patient'.