Excess Treatment Costs (ETCs) occur when the costs of a drug or treatment are higher in a research study than in routine care. These costs are the responsibility of the NHS.
As of October 1st 2018, NHS England are trialing out a new model of reimbursing ETCs in non-commercial research. They hope to simplify the process, cut delays during study setup, and maximise patient recruitment. The new system includes a threshold under which ETCs will need to be absorbed by non-primary care providers participating in studies.
Under the new system, there will be a single point of access for all proposals involving ETCs, in order to make the process simpler for applying researchers.
The 15 NIHR Local Clinical Research Networks (LCRNs) will help manage the ETC payments from a central fund, on behalf of their local Clinical Commissioning Groups (CCGs) and in collaboration with NHS England’s Specialised Commissioning function.
The NIHR Clinical Research Network (CRN) is supporting the development of this central fund on behalf of CCGs.
The Schedule of Events Cost Attribution Tool (SoECAT)
As part of a six month pilot, researchers applying for Health Research Authority (HRA) approval for clinical research studies taking place in England will need to complete a new form known as a Schedule of Events Cost Attribution Tool (SoECAT).
The SoECAT is a spreadsheet template that calculates the different activities and costs associated with clinical research in a standardised way. Further information about the new system and a preview of the SoECAT can be found on at the following links:
- NIHR Supporting and applying research in the NHS
- Schedule of Events Cost Attribution Tool (SoECAT)
- Supporting guidance for researchers, study teams and sponsors to complete the SoECAT
Sign off requirement by AcoRD specialists
The SoECAT will need to be signed off by an NIHR AcoRD Specialist, who will confirm that the attribution is accurate before submission to the HRA. Sign off is required for the study to be eligible for the NIHR Clinical Research Network Portfolio and associated support.
Local AcoRD Specialists can signpost researchers to AcORD resources and training, provide specialist advice and support for activity cost attribution, and help to resolve queries.
If you are applying for funding for a clinical research project that requires HRA approval, you should engage with AcoRD specialists and let them know support will be required as early as possible. Read the NIHR’s ‘roadmap’ for researchers for more details.
If you are applying for Diabetes UK funding for a study taking place in the NHS, you will need to submit the signed off SoECAT as part of your online application. For any queries, please contact email@example.com.