These arrangements respond to feedback from companies about the need to speed up and simplify costing and contracting with the NHS for commercial contract research. The new arrangements are mandated through the National Directive on Commercial Contract Research Studies, which forms part of the NHS England standard contract.
The new directive sets out that, from 1 October 2018, NHS organisations in England involved in commercial contract research must:
- use an unmodified model site agreement
- use the standard costing methodology (the NIHR industry costing template).
Confirming these requirements through the NHS England standard contract embeds these tools and means we can now work with NHS England and the NIHR to further harmonise and speed up study site set-up, through a single, fair and binding determination of prices.
HRA Chief Executive, Teresa Allen
By simplifying and improving research arrangements, we can support patients to receive the best care, by speeding up their access to new treatments.
I hope that over the next few years the work we’ve been doing with our partner organisations to facilitate the set-up of commercial contract research will be bedded in, helping to eliminate uncertainties and delays and reduce administration costs for NHS providers and industry.
As partner organisations, we are working collaboratively with NHS providers and industry to ensure that we have up to date and appropriate model agreements that can be used without negotiation between sponsors and sites.
Commercial research applicants should use the current Model Clinical Trials Agreement (mCTA) in unmodified form.
We are asking companies to contact us if and when they feel they require modifications so we can waive the requirement on trusts to accept the template on an individual study basis where justified, or work with the community to iterate the template agreement.
Jonathan Sheffield, Chief Executive of the NIHR Clinical Research Network
Whilst the NIHR has supported strong growth in the delivery of commercial research in recent years, we know that costing and contracting issues are also delaying set-up times, and impacting on patient access to new treatments.
The introduction of a nationwide approach will address this by removing variation across NHS providers, resulting in a consistent and simplified costing and contract process.
We will be working closely with HRA, NHS England and partners over the coming months to implement this work, which will benefit patients, NHS providers and the wider UK economy.
Sam Roberts, Director of Innovation and Life Sciences at NHS England
We have worked with funders, researchers and clinicians across England to develop this new way of working.
Delays in the setting up commercial contract research leads ultimately to delays in new treatments becoming available to patients, so we are determined to eliminate these wherever possible.
In partnership with the research community, we will continue to work as a unified system to ensure the NHS remains at the forefront of worldwide research activity.
More information about NHS costing methodology can be found in this animated video: Supporting research in the NHS: Clinical Contract Research.
The NIHR website, which is regularly updated to provide the latest information, contains further details about the changes to support research in the NHS.