Clinical trial design in head and neck cancer-challenges and opportunities

Abstract Over the last few decades, the treatment of head and neck cancer has evolved in a multidisciplinary approach. While small gains in outcomes have been produced, much more work needs to be done to have achieved significant gains in survival and quality of life. This highlights the importance of carrying out well designed clinical trials. Several accrual hurdles have been identified over the years, including relative low incidences of head and neck cancer, clinician and patient-driven factors, and standardization of available resources. From a trial implementation perspective, appropriate site selection, meaningful endpoints, and trial schemas also contribute to the success of a study. This chapter will discuss the current challenges in head and neck trials implementation and the opportunities available to ensure the execution of meaningful research.