Abstract
The use of proton beam therapy (PBT) offers the opportunity to improve greater conformality of radiotherapy treatment delivery in some patients. However, it is associated with a high capital cost and the need to build new dedicated facilities. We discuss how the global radiotherapy community can respond to the challenge of producing high-quality evidence of clinical benefit from PBT in adult patients. In the UK, the National Cancer Research Institute-funded Clinical and Radiotherapy Translational group has established the PBT Clinical Trial Strategy Group. An eight-point framework is described that can assist the development and delivery of high-quality clinical trials.