How to design clinical trials which assess the advantage of new technologies
Price, Gareth J
Price, Gareth J
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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.
Authors
Description
Date
2022
Publisher
Collections
Keywords
Type
Meetings and Proceedings
Citation
Price G. NTCP modelling: A tool for designing clinical trials. Radiotherapy and Oncology. 2022 May;170:S854-S. PubMed PMID: WOS:000806764200487.