ESTRO PT 2018

Sheehan M, et al. J Med Ethics 2014;40:572–575. Cont….

Methodological and evidential considerations

… . Where the dose distribution with CPRT is substantially improved and suggests substantial superiority to other treatments and existing clinical results suggest significant superiority, a RCTwould be neither necessary nor appropriate. …. In some cases, there is a need for more definitive phase I/II studies. In other cases, where there is more compelling evidence from phase II trials, there is an important need for further research progression into definitive phase III studies in order to demonstrate therapeutic outcomes. …..These treatment modalities are complex interventions, which must be adequately reflected in the design and conduct of research studies. ……Where the results of phase II studies are inconclusive, there are clear indications for definitive phase III trials (as eg, in early stage peripheral lung cancer).