New processes that will simplify arrangements for both commercial and non-commercial research in the NHS will start on 1 October.
This follows the publication of the 12 actions to support and apply research in the NHS on 4 May 2018, which recognise that while the NHS is a vibrant research environment, more should be done to facilitate research and innovation.
This phase focuses on:
- better management of excess treatments costs in non-commercial research
- reducing delays and improving commercial clinical research set up and reporting.
The action was prompted by a public consultation by NHS England – which ran from November 2017 to February 2018 – and was undertaken in partnership with a number of organisations including ourselves, the Department of Health and Social Care (DHSC), the National Institute for Health Research (NIHR), Health and Care Research Wales (HCRW) and NHS Improvement (NHSI).
The emphasis on simplifying and improving research arrangements is ultimately intended to improve future health and care for patients.
Excess treatment costs in non-commercial clinical research
There has been continued frustration about the complexity and variation in processes for commissioners and providers agreeing excess treatment costs (ETCs).
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 full implementation in April 2019.
This change is being managed through a partnership of organisations across the research landscape, ensuring a consistency of approach and a more streamlined process.
More information
The NIHR website, which is regularly updated to provide the latest information, contains more information about the changes.
This includes the Schedule of Events Cost Attribution Tool (SoECAT) and supporting guidance for researchers, study teams and sponsors. The tool has been developed from our own current Schedule of Events, and is designed to capture the different costs associated with clinical research and attribute them accordingly as part of the application for research funding.
Applicants for HRA Approval who have not completed and submitted a SoECAT during their application for research funding may continue to use our existing Schedule of Events, which is available on our preparing study documentation page. Applicants with NIHR portfolio eligible studies may wish to seek advice on this from their local AcoRD specialist prior to submission, as it may be more appropriate to submit a SoECAT where such studies will incur NHS Excess Treatment Costs.
Other resources
- Association
of Medical Research Charities blog on changes to the way excess treatment costs
are paid
- Research and Development Forum briefing note on managing excess treatment costs in non-commercial research.
Reducing delays and improving commercial clinical research set up and reporting
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.
In implementing the recommendations arising from the consultation, there will be greater certainty and reduced 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.
The key elements focused on addressing this and the impact of this work will include:
- Establishing a standard, binding process for assessing and determining contract values for commercial contract studies in England.
- Reaffirming the existing requirement for providers to report and publish clinical trial initiation and delivery data for all clinical trials.
- Requiring NHS providers in England to only agree unmodified model agreements as directed by HRA Approval, unless otherwise specified.
More information on eliminating delays and further improving commercial clinical research set up and reporting can be found on the NIHR website.