ECMC Report: Imaging reviews for setting up Early-Phase Oncology Trials
The Experimental Cancer Medicine Centre (ECMC) Network, in partnership with the Health Research Authority (HRA), has been driving a key project to accelerate the setup of commercially sponsored early-phase oncology trials in the UK. This initiative is a priority for the UK, highlighted in the Government’s response to Lord O'Shaughnessy's review of commercial clinical trials and is part of the UK Recovery Resilience and Growth (RRG) programme.
As the ECMC’s central Programme Office we are pleased to share an extensive report detailing the advancements in resolving issues within the national research imaging set-up and at individual sites. While progress has been made, it is important to remain transparent that effective solutions await regulatory changes which will require persistence and a concerted effort from multiple organisations to achieve. Central to this project is ensuring continued collaboration and partnership, working closely with key stakeholders to develop effective solutions. Extensive consultation with Medical Physics Experts (MPEs) and Clinical Radiation Experts (CREs) has been pivotal.
The report (found here) focusses on developments made with regards to Imaging, one of the pivotal themes of this piece of work. It outlines the main challenges in the imaging setup pathway and showcases the efforts made to address these issues. The paper’s aim is to showcase the investigations made by the ECMC Programme Office and stakeholders as well as share the valuable lessons learned during this project accompanied by the rationale for decision making.
These challenges have been identified as six key aspects of the Imaging review process that are causing severe delays for patients to be able to access their treatments promptly. It was found that the challenges being faced are a lack of an established standard of care (SoC) imaging pathway, interpretation of the Ionising Radiation (Medical Exposure) Regulations 2017, specifically in regard to patients with advanced conditions, and accessing necessary information for set-up. Additionally, there is significant variation in the site-level process duration and a reluctance to accept assurances from colleagues. The implementation of an HRA Radiation Assurance service has not streamlined the imaging set-up process as intended.
The report offers detailed information as to why these specific challenges are occurring, offering key recommendations vital to their resolution. It is clear that the ECMC and project stakeholders must now evaluate which challenges warrant further exploration and which, due to constraints in available resources or because they fall outside the Network’s influence, may be deemed impractical or unattainable.
The Department of Health and Social Care (DHSC) has placed clinical research delivery at the forefront of its vision for a healthier future. This commitment is further emphasised by the recent review led by Lord O'Shaughnessy.
The Programme Office, alongside its valued partners, remains dedicated to collaborative action. We recognise the challenges identified in the review, and they will be a top priority for us moving forward. Our approach will be guided by three key principles:
Feasibility: We will ensure proposed solutions are realistic and achievable within the current landscape.
Resource Requirements: We will carefully consider the resources needed to implement effective changes.
Alignment: All actions will be carefully assessed for their alignment with the Network's strategic goals and operational capacity.
Through this collaborative spirit, we are confident in addressing the identified challenges and propelling the UK's clinical research landscape forward.
If you have any questions or would like to contribute to this project, please contact: sharan.sandhu@cancer.org.uk