(F1260) "IT'S REALLY AN ADVENTURE": A QUALITATIVE STUDY EXPLORING EXPERIENCES OF PROFESSIONALS INVOLVED IN WORKING WITH ADVANCED THERAPEUTICS IN THE NETHERLANDS
PhD Student Murdoch Childrens Research Institute Melbourne, Victoria, Australia
Abstract: To date, few clinical studies have been conducted in Australia involving novel cell and gene therapies. Even fewer products have been approved for use. However, as an increasing number are being evaluated across the globe, there is an increasing need and interest to provide Australian patients with access to these products, often referred to as “advanced therapies”. Given the complexity of implementing these therapies, understanding barriers and enablers to implementation in a comparable healthcare system is key to successfully translating these new technologies into clinical practice. In this study we focused on the experiences of professionals in the Netherlands based at a single tertiary hospital who were involved in delivering approved cell or gene therapies, or who were conducting or starting up trials of gene or cell therapies. Particular attention was paid to a current international clinical trial of a genetically modified-cell therapy developed by researchers based at the same tertiary hospital in The Netherlands. Semi-structured interviews were conducted with 11 professionals and explored their experiences including what they found facilitated the process or made it more challenging. Participants were from a range of specialities and roles within the hospital. Therefore it represented a variety of facets of involvement in the implementation process. Inductive Content Analysis was used to identify barriers and enablers. Categories of barriers included the complexity of the regulatory system (particularly for those who were doing this for the first time), and the logistical challenges of implementing such a procedure within an existing hospital structure. Categories of enablers included strong clinic-lab relationships, an institutional investment in appropriate facilities and knowledgeable personnel, and the operational similarity of the novel procedure with existing therapeutic options. This study provides insights into proactive steps that can be taken towards being prepared to offer cell and gene therapies. This is a timely reminder for Australia that attention should be paid to questions of implementation and access to advanced therapies, and provides useful steps that healthcare institutions need to consider as they ready themselves and their workforce to deliver these products.
Funding Source: The Novo Nordisk Foundation Centre for Stem Cell Medicine, reNEW, Novo Nordisk Foundation grant number NNF21CC0073729 The Henry and Rachael Ackman Travelling Scholarship 2024 (UTR6.170)
