ABSTRACT
The favourable beam properties of protons over photons can be translated into clinical benefits in two ways. First, protons can be used to escalate the dose to the target with limited or no excess dose deposition to the normal tissues, with the aim to improve loco-regional tumour control without enhancing radiation-induced side effects. This chapter discusses some problems and pitfalls of randomised controlled trials (RCTs) when comparing radiation technologies when radiation-induced side effects are used as the primary end point. It examines a rapid learning health care (RLHC) system and provides major opportunities for continuous improvement and subsequent evaluation of the beneficial effects of new radiation technology. In addition, the different aspects of the model-based approach, an alternative evidence-based methodology for RCTs, is discussed. The model-based approach requires continuous prospective assessment of radiation-induced toxicity over time, in which every patient treated with any form of radiotherapy is included.
