Supporting and applying research in the NHS
Supporting research in the NHS - simplifying research arrangements to improve patient care
NHS England and the National Institute for Health Research (NIHR) have published a joint statement committing to 12 actions to support and apply research in the NHS.
In connection with this, NHS England – along with partners including the Department of Health and Social Care (DHSC), the National Institute for Health Research (NIHR), the Health Research Authority (HRA) and NHS Improvement (NHSI) – carried out a public consultation ‘Supporting research in the NHS’ from November 2017 to February 2018. It centred around the first two of the twelve actions: better managing excess treatments costs in non-commercial research, as well as plans to reduce delays and improve commercial clinical research set up and reporting. This focus on simplifying and improving research arrangements, is ultimately intended to improve future health and care for patients.
The consultation gathered views from across the clinical research landscape, which have been captured in the response. Following the publication of the response, there has been a significant amount of work undertaken to address the issues and opportunities identified.
This webpage will continue to be updated regularly to provide the latest information around the actions being undertaken to reduce delays during study set-up and to speed up access for patients.
Better managing excess treatment costs - latest update and clarification 27 September 2018
There has been continued frustration about the complexity and variation in processes for commissioners and providers agreeing excess treatment costs (ETCs).
Scope of the new arrangements
To address the issues identified, the way in which excess treatment costs are met is changing and a trial period for the new arrangements will roll out from 1 October 2018, through to April 2019.
Please note that it was previously stated that the new arrangements will apply to research calls after 1 October 2018 by NIHR and NIHR partners. To clarify, the new arrangements for completing a Schedule of Events Cost Attribution Tool (SoECAT - for more information, see section below) at application stage will apply to:
- New calls for single stage applications issued after 1 October 2018
- Invitations to submit the second and final stage of an application where the invitation is issued after 1 October 2018 (the call for the first stage application may have been issued prior to 1 October 2018)
The AMRC has published a blog on what this means for funders.
Ongoing studies open to recruitment after 1 October 2018 will also be transitioned into the new arrangements ensuring the continuation of existing ETC payments.
The impact of this work will:
- Enable the 15 NIHR Local Clinical Research Networks (LCRNs) to help manage the excess treatment costs process on behalf of their local Clinical Commissioning Groups (CCGs) and in collaboration with NHS England Specialised Commissioning. This single point of access for all proposals for which excess treatment costs may be applicable is designed to make the process much simpler for researchers to navigate.
- Establish a more rapid, standardised and consistent process for the management of excess treatment costs to avoid delays during study set up and to maximise patient recruitment.
- Set a threshold under which excess treatment costs will need to be absorbed by non-primary care providers participating in studies.
Defining ETC values for each study
To underpin the new arrangements, a cost attribution tool has been created in partnership with charity funders and research sponsors. This tool provides a standardised approach for attributing the costs of health and social care research and development (AcoRD) across England. As part of their funding applications, researchers will be required to complete this new tool, known as a Schedule of Events Cost Attribution Tool (SoECAT) for clinical research, which has been developed from the current HRA Schedule of Events. This tool is designed to capture the different costs associated with clinical research and attribute them accordingly.
Non-commercial research sponsors have a responsibility to ensure the study is appropriately costed and attributed
Attribution support is available for investigators, study teams and their R&D offices through AcoRD specialists in the NIHR Local Clinical Research Network. Find out more about how to access this support via the Study Support Service.
Under the new arrangements, sign off via the tool is required to confirm the study attribution complies with the Department of Health and Social Care AcoRD guidance. This early attribution support will underpin the excess treatment cost management process by providing formal sign off, supporting the role of the research sponsor and lead R&D office or Clinical Trial Unit. Completion of the Schedule of Events Cost Attribution Template will be required for studies eligible for the NIHR portfolio and the support this provides, which will include access to excess treatment cost payments under the new arrangements. This ETC value, alongside recruitment activity in the NIHR Central Portfolio Management System, will then be utilised to inform the payments to NHS providers.
A routemap is available to provide an high level overview for researchers and research sponsors accessing ETCs from 1 October 2018.
An animation, ‘Supporting research in the NHS: Excess Treatment Costs’ is available to learn more about these new arrangements.
Eliminating delays and further improving commercial clinical research set up and reporting - latest update 26 September 2018
The consultation also proposed options to streamline and improve the process for commercial contract research. It set out proposals aimed at eliminating uncertainties and delays in site set up for commercial contract research. In implementing the recommendations arising from the consultation, there will be greater certainty and reduce administration costs for NHS providers and industry alike, making the NHS in England a more attractive base for research. This is good news for patients, researchers, providers and the wider UK economy.
While commercial contract research has been continuing to grow steadily, feedback from industry partners continues to highlight that costing and contracting issues are delaying set up times and impacting the speed of access to new treatments.
There are two key elements focused on addressing this and the impact of this work will include:
1. Establishing a standard, binding process for assessing and determining contract values for commercial contract studies in England.
To ensure a fair, transparent and consistent approach to research costing across the country:
- A multi-stakeholder advisory group has been created to inform the approach, which includes participation from NHS representatives (R&D Forum, UK R&D Leaders and the Association of UK University Hospitals AUKUH), research infrastructure groups (UK Clinical Research Facilities Network UK CRF, Experimental Cancer Medicine Centres ECMC and Local CRNs with regional models in place) and industry groups (Association of the British Pharmaceutical Industry ABPI via their Clinical Research Expert Network CREN, the Association of British HealthTech Industries ABHI, Commercial Clinical Operations Group cCOG and Ethical Medicines Industry Group EMIG).
- Access the outline of principles for a single contract review approach for commercial contract studies with clear expectations, roles and escalations.
- An implementation roadmap which includes the development of an online industry costing tool to support a single contract value review process.
Revisions to the NHS Standard Contract as outlined in the consultation response will come into force on 1 October. Details of the requirements that providers, and therefore commercial companies, will subsequently need to adhere to for commercial contract research will be set out in the National Directive, which has been jointly developed by NHS England, HRA and NIHR. The National Directive sets out the nation-wide approaches for commercial contract research set-up which:
- Mandates the use of an unmodified model site agreement from 1 October 2018
- Mandates the use of the standard costing methodology (the NIHR Industry Costing Template) from 1 October 2018
- Introduces the concept of a single contract review process which will be further developed for future implementation.
Further ongoing work includes:
- Ratifying an updated and extended list of investigations and prices working with experts for specific areas across England and the devolved nations. This will be available to view via the NIHR website in the coming weeks.
- Initiating the identification of existing research costing experts across the NHS.
- Working with the NHS R&D Forum to develop a professional training package to recognise this important role with both NHS and industry input.
2. Reaffirming the existing requirement for providers to report and publish clinical trial initiation and delivery data for all clinical trials.
The NIHR website features further information and the updated guidance.
The NIHR Central Commissioning Facility and Clinical Research Network are exploring how to automate performance data collation to reduce the burden of manual collection, reporting and publication.
This study-wide approach is designed to simplify costing and contract processes to attract more commercial research and avoid delays in patient access to research.
An animation, ‘Supporting research in the NHS: Commercial Contract Research’ is available to learn more about these plans.