Quality Assurance in Multi-Modality Oesophago-Gastric Cancer Clinical Trials: Past, Present and Future Perspectives

Abstract

Clinical trials must ensure the quality of both standard and interventional treatments to rigorously evaluate potential benefits, avoid adverse outcomes, and maintain the integrity of results. Quality assurance (QA) endeavours to achieve this and is fundamental to all clinical trial elements, though variation exists between specialties. For radiotherapy (RT) in the UK, the NIHR-funded national Radiotherapy Trials Quality Assurance (RTTQA) group has centralised trial RTQA processes across the RT pathway enabling a robust, consistent, efficient and multidisciplinary approach, replacing piecemeal, trial-by-trial application for QA funding. Meanwhile, the surgical community are moving towards standardised QA processes but has yet to achieve this universally. For SACT, though the importance of QA is recognised, under-reporting persists, and the increasing number and diversity of agents used pose challenges. QA in pathology and radiology is also growing as the complexity of clinical trials increases. Internationally, the EORTC has developed QA processes across domains, but uncertainty and challenges in QA implementation remain. Additionally, while the benefits of trial QA are now recognised, the potential negative effects of QA need to be recognised. Using illustrative examples from contemporary oesophago-gastric cancer studies, we further explore the current status of clinical trial QA across these specialties.