ECMC network response to Lord O'Shaughnessy's review into commercial clinical trials in the UK

On Friday 26 May, Lord James O’Shaughnessy published the outcome of his independent review into the commercial clinical trials landscape. The review complements existing commitments in the Clinical Research Delivery Vision which ECMC are a delivery partner for. The ECMC welcomes the review’s recommendations.  Now, more than ever, it is essential that the components of the system are working together to address the current challenges for UK clinical trials. Here we highlight how the ECMC network activities will support our delivery partners in their response to the recommendations highlighted in the review.

 

The ECMC network is a collaborative, internationally competitive national network of centres delivering early phase   cancer trials. These trials accelerate the most promising innovations from the academic and industry sectors into the cancer medicines of tomorrow. The Network is funded through a unique partnership of Cancer Research UK, National Institute for Health and Care Research, The Little Princess Trust, Chief Scientist Office Scotland, Health and Care Research Wales and Health and Social Care in Northern Ireland.

 

We deliver clinical trials across the length and breadth of the UK and we know that clinical trials are facing challenges right now. We will use our expertise to help tackle these challenges and we particularly want to attract more Phase 1 and 2a early-phase commercial trials to the UK.  

 

ECMC Accelerating study set up: The ECMC network has been working in partnership with the Health Research Authority (HRA) to accelerate the set-up of early phase oncology trials with oversight provided by UK Recovery, Resilience and Growth (RRG) Programme. The aim is to create routes that will allow us to compete on set up times internationally and to deliver improvements in trial set-up that could benefit the entire clinical trials portfolio. 

 

We are working with stakeholders across the UK including sponsors, site R&D departments, regulators, clinical teams, and patients, to co-create new ways of working and pilot new approaches around three identified challenges to study set up: 

 

National Contract Value Review (NCVR) expansion pilot: NCVR is a process for standardised, national approach to costing for commercial contract research. A programme to implement this in England is being led by NHS England, alongside equivalent implementation processes in Scotland, Wales and Northern Ireland. The NCVR programme delivery partners, Health Research Authority, National Institute for Health and Care Research (NIHR) and the Department for Health and Social Care (DHSC) are seeking to expand its scope to include early phase studies and advanced therapy medicinal products (ATMPs) and are working with the ECMC network to shape the use of national tools like the industry costing template (iCT) and the NCVR procedure to effectively cost research while also accelerating study setup

 

The ECMC will be ‘early adopters’ of national review standards for early phase oncology, which are currently being generated across specialities and settings. Recently defined review standards include oncology, ATMP and gene therapy. One of the agreed principles for stage 2 of the NCVR programme is that there will be a standardised finance appendix to the mCTA into which the NCVR determined budget will drop.  

 

We look forward to playing our part to support our partners in improving the UK early phase clinical trials ecosystem. If you have any questions or comments, please email Sheona Scales, Head of the ECMC Programme Office at sheona.scales@cancer.org.uk