Proton Beam Therapy - the Challenges of Delivering High-quality Evidence of Clinical Benefit.

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.