ESTRO 2024 - Abstract Book

S5911

RTT - Service evaluation, quality assurance and risk management

ESTRO 2024

1800

Digital Poster

Retrospective analysis of clinical trial patient demographics within a large UK radiotherapy centre

Lee R Whiteside 1 , Clare Hodgson 2 , Gordon Cath 3

1 The Christie, Radiotherapy, Manchester, United Kingdom. 2 The Christie, Digital Services, Manchester, United Kingdom. 3 University of Liverpool, School of Life Sciences, Liverpool, United Kingdom

Purpose/Objective:

Clinical research is a vital source of evidence generation for the safe administration and efficacy assessment of new therapies. However, in order to synthesise valid and reliable data from interventional studies, adequate numbers of volunteers must first be successfully recruited. Clinical trials which recruit at higher rates demonstrate an increase in the speed at which technological advances occur, corresponding to improvements in outcomes. Yet most cancer clinical trials fail to reach enrolment goals (Meyer, Woldu and Sheets, 2021). Diverse groups may be excluded from clinical trial entry and the literature suggests that reasons for this is likely multi faceted. Studies utilising homogenous samples comprising of limited demographics within a diverse population impacts study fidelity, limiting the clinical application of study results. Therefore, enhancing the heterogeneity of trial participants will ensure outcomes generated give parity to minority groups, thus enabling a more accurate representation of the population. The current work aims to provide an analysis of patient demographic features between standard of care (SoC) and clinical trial (CT) patients undergoing radiotherapy treatment across a three-year period. The author studied five domains -inclusive of age, gender, ethnicity, treatment centre and disease site across the two cohorts. The analysis enables exploration of ways in which future recruitment strategies could be optimized to actively recruit underrepresented populations. Local approvals were obtained before commencing the evaluation. A positivistic, longitudinal, quantitative approach was adopted to collate appropriate data to identify comparative trends over a defined period. An in-house report was created using the MOSAIQ radiotherapy record and verify system (V2.83 Elekta, Stockholm) for patients receiving radiotherapy between January 1st 2017 and December 31st 2019. This timeframe was selected to avoid the COVID 19 pandemic which impacted standard trial recruitment practice. This report was combined with the local Master Patient Index data, which fused ethnicity information into the dataset. A Mann-Whitney U test compared patient age between the two cohorts (SoC vs. CT). For the 2 binary variables (gender and location), chi-squared tests were utilised to compare trial and non-trial patients. For the disease site metric, an overall chi-squared test, followed by post-hoc tests were performed. All tests were two-tailed. As multiple comparisons were carried out, a p value of <0.01 was considered statistically significant. For ethnicity, trends were identified, but no statistical analysis was performed due to the large omissions within the data sample. Material/Methods: