Development of a robust clinical research feasability process in a paediatric oncology unit: Quality improvement from the ground up.

Abstract

Monash Children’s Cancer Centre (CCC), including the clinical research space, has been exponentially growing over the past decade. In 2022, an internal business assessment of the CCC clinical research department identified a number of areas for appraisal and improvement, including the site feasibility process. The feasibility stage was identified as a key area of potential risk. The consequences of opening unfeasible studies, or studies without appropriate risk mitigation plans, poses significant ethical, financial, safety, operational, strategic and compliance risk. The need to undertake a full review of the current feasibility processes and develop a robust new system was not only warranted but essential to safeguarding CCC and maintaining and optimising the research reputation of Monash Health.