How to design clinical trials which assess the advantage of new technologies

Abstract

Abstract Text Much of the improvement in radiotherapy care witnessed seen over the last few decades has been driven by the clinical adoption of technical innovations. However, the well-known phase I-III randomised controlled trial framework used to assess new drug treatments is often not well suited to the evaluation of such innovations. As a result, many technical changes in radiotherapy practice are implemented without robust evidence of their impact on clinical outcome. In this presentation we use historic and contemporary examples to explore the need for such evidence, the reasons conventional clinical trials can be inappropriate for the evaluation of new techniques and technologies, and some of the approaches used and proposed to address this unmet need in clinical oncology. The talk will cover novel trial designs that are finding use in radiotherapy centres, the potential of pragmatic evaluations, and the advantages and disadvantages of observational studies, including prospective registries (e.g. MOMENTUM). We will introduce frameworks developed by investigators and regulatory bodies to draw on data from different study types when introducing and evaluating new technologies (e.g. R-IDEAL), and the impact that newly emerging analytical techniques such as causal inference and in-silico trials may have on these approaches in the future. Lastly, we will discuss whether the Leaning Healthcare System concept, that combines digital healthcare initiatives and clinical studies with the continuous improvement approaches used in Quality Improvement, might have a role in the introduction, evaluation, and potential optimisation of technical changes in radiotherapy practice.