Accelerating Study Set Up – An Imaging and Pharmacy Perspective
The ECMC Programme Office has continued to reflect upon Lord O’Shaughnessy’s review of the clinical trial landscape. We have focussed on Lord O’Shaughnessy’s observation that ‘clinical trial set-up and approval processes in the UK are slow and bureaucratic, especially compared to other countries.’ Over the past few months, it has been the Programme Office’s goal to explore this sentiment and work with our network Imaging and Pharmacy colleagues to discuss practical solutions to encourage speedier support department set-up when opening a new trial.
Our Optimal Process Workshop earlier this year created forums for Imaging and Pharmacy colleagues to interrogate current national and site level processes and ask important questions like:
- What constitutes ‘set up’?
- What is the minimum information required to enable set-up, including costings?
- At what point should all information be received in the ‘set-up’ process?
We are also working alongside the HRA to strengthen the HRA Technical Assurances processes for Imaging and Pharmacy review through workshop and discussions. These processes were viewed positively, and work is underway to support the processes to accommodate Early Phase (EP) and Advanced Therapy Medicinal Product (ATMP) oncology studies.
The Programme Office was also fortunate enough to speak with Claire-Louise Chapple, Head of Imaging Physics and Radiation Safety at Newcastle NHS Foundation Trust. Claire-Louise is a certificated MPE in diagnostic radiology and a HRA technical assurance reviewer. Our ECMC working group is collaborating with the HRA to enhance the centralised imaging review process for early phase and ATIMP cancer trials and therefore Claire-Louise’s input has been hugely valuable.
We asked Claire why she feels it’s important to be part of the ECMC working group and optimise the study set-up pathway. The aim of our working group is to bring together experts in Support Department Study Set Up to co-create an optimal process and define the ‘minimum information set’ needed to open the study.
Claire-Louise: ‘I am pleased to be a member of the ECMC Working Group as this is an important initiative to help ensure that the wealth of important medical research that is ongoing, both in the UK and around the world, can be implemented clinically as quickly and safely as possible. This will have great benefit to patients in terms of improved treatment outcomes.’
We asked how Clare-Louise’s area of expertise could contribute to making clinical trials more efficient:
Claire-Louise: ‘As a Medical Physics Expert I represent one of the professional groups that are required to provide input and authorisation to ethical submissions. This process can sometimes give rise to a delay in the approval and commencement of clinical trials so identification of any issues with, and improvements to, this part of the process will improve overall efficiency.’
With the input of experts like Claire-Louise the ECMC Programme Office is optimistic that significant progress can be made in accelerating study set-up. Our learnings from the Working Group have allowed for a proposal to be taken to the broader stakeholder group and regulators for consideration with the hope that this will lead to a re-design of the current process and a pilot being held as soon as possible.
Watch out for further updates on this project on our website and in upcoming newsletters. If you have any questions or would like to contribute discussions, please contact: sharan.sandhu@cancer.org.uk