Randomized controlled trials and alternative study designs in surgical oncology

Abstract

Surgery is central to the cure of most solid cancers and an integral part of modern multimodal cancer management for early and advanced stage cancers. Decisions made by surgeons and multidisciplinary team members are based on best available knowledge for the defined clinical situation at hand. While surgery is both an art and a science, good decision-making requires data that are robust, valid, representative and, applicable to most if not all patients with a specific cancer. Such data largely comes from clinical observations and registries, and more preferably from trials conducted with the specific purpose of arriving at new answers. As part of the ESSO core curriculum development an increased focus has been put on the need to enhance research literacy among surgical candidates. As an expansion of the curriculum catalogue list and to enhance the educational value, we here present a set of principles and emerging concepts which applies to surgical oncologist for reading, understanding, planning and contributing to future surgeon-led cancer trials.