Redefining clinical trial strategic design to support drug approval in medical oncology.

Randomized clinical trials represent the gold standard for the introduction of innovative therapies in medical oncology, and they provide the highest level of evidence to ascertain the clinical activity of new drugs or novel combinations. However, the current infrastructure of clinical trials supporting innovative drug approvals is challenged by an increased body of knowledge concerning tumor biology and therapy resistance, a fast-growing armamentarium of novel anticancer compounds, an impressively upscaled data analysis capacity, as well as increasing costs related to clinical trials management. In this scenario, modern clinical trial designs need to evolve to expedite new drug approvals by tailoring patients' treatment strategies according to their medical needs. Balanced, patient-oriented clinical trial designs are eagerly warranted to increase their efficiency, to include the fast pace of technological innovations and scientific discoveries, and, ultimately, to face the challenges of the modern medical oncology field.