Accelerated Pathway for Early Phase Trials: November 2022 Update
15 Nov 2022
In October the Experimental Cancer Medicine Centre (ECMC) programme office held a webinar to outline the ECMC accelerated study set-up pathway project. A recording of this session, including Q&A session can be accessed here. The talk highlighted the urgent need for this project and set the scene for why the ECMC network is the perfect test bed for building efficiencies into the study set-up pathway. Louise Knowles, Deputy Director, Head of Research Capacity and Growth at the Department of Health and Social Care, spoke on behalf of the DHSC to place this project in the UK governments vision for streamlined, efficient and innovative research. Dr Janet Messer, Director of the Approvals Service at the Health Research Authority, spoke on behalf of the HRA to further reiterate the urgent need for reform and to expand on other key initiatives that are taking place in this space.
Over 100 hours of consultation within the ECMC network to define areas of early phase clinical trial set-up for improvement have been completed. This early information collection stage highlighted opportunities for acceleration, which were expanded upon in this webinar:
- availability of robust trial information for support departments to enable capacity and capability assessment and later stage amendments
- study sign off and decision making processes and availability of research experienced and trained resource in both service departments and sponsor organisations
- duplication and prolonged negotiation when finalising costings and contracts.
To allow for creative and collaborative solutions to be generated the ECMC Programme Office will work with the network and key stakeholders to co-create approaches, learning from set up processes in other countries to overcome these challenges A series of roundtable discussions are being arranged to discuss potential solutions to test
To ensure patients have the best clinical trials available to them and to bring sponsors confidence back to the UK we need communication, collaboration and co-creation of solutions. Please contact Sharan Sandhu for further information on how you can get involved. We look forward to collaborating with you on this important project.
Background to the project
The UK's position in the worldwide rankings for industry clinical trial continues to lag behind comparable countries for ability to both initiate and deliver clinical research. A recent report by the ABPI attributes this decline to ‘consistently slow and variable study set-up timelines’. The UK government’s Saving and Improving Lives policy piece highlights the need for improved efficacy of trial set-up and delivery. In response, the ECMC network has set up a project, in partnership with the Health Research Authority (HRA), aiming to develop and pilot revised approaches to set-up and delivery of early-phase clinical oncology trials within the ECMC Network. This service improvement project reports into the Research Recovery, Resilience and Growth (RRG) Programme Board as part of the implementation plan for the UK Vision for Clinical Research Delivery.