What does it mean for NIHR Clinical Research Networks?
The new UKCRN Industry Costing Template will:
- Provide a clear methodology to calculate consistent and transparent prices associated with industry-sponsored studies to support both industry and the NIHR Networks
- Ensure all NHS Trusts are fully reimbursed for any activities associated with industry studies
- Identify standard rates for staff time, overheads, capacity building, costs for departments supporting research and investigations, which are acceptable to all parties
- Be facilitated by the NIHR Networks to speed up the negotiation process for costing
- Focus costing negotiations around specific local site issues
- Support rapid identification of anticipated costs for pharmaceutical and biotech studies in secondary care
Over the last eighteen months, the UK Clinical Research Network has been leading on a Costing Project to develop a clear and transparent process which will provide industry and the NHS with a consistent method of costing industry contract research carried out within the NIHR Networks. This version of the UKCRN Industry Costing Template is designed for contract trials of pharmaceutical and biotechnology products conducted in secondary care. Templates suitable for use in primary care and in studies of medical devices are under development and will be released in due course.
Frequently Asked Questions
How was the UKCRN Costing Process developed and who agreed its components? The development of the new UKCRN Costing Process involved extensive consultation and collaboration with key stakeholders to ensure that an appropriate, transparent and fair process of costing Industry sponsored studies was developed. This was achieved with active input from members of the NHS R&D Forum, NHS R&D staff, Pharmaceutical Industry, Contract Research Organisations, Department of Health, University/ academic sector, NIHR Topic and Comprehensive Clinical Research Networks and NHS Pharmacy Services. The Template has been piloted and the UKCRN Costing Group and UKCRC Industry Road Map Group consider it ready for launch.
Who will complete the UKCRN Industry Costing Template?
The UKCRN Industry Costing Template will be completed by the company (either CRO or sponsor) and submitted to the Network with the documents for Adoption. It will then be checked by the appropriate Network Coordinating Centre for accuracy and completeness before it is sent to potential sites/Trusts by the Local Research Network.
How can I check that all appropriate NHS costs are included?
The UKCRN Industry Costing Template has been designed to identify every activity associated with an individual study. There is a full breakdown of all costs so you can identify both the true costs and the final prices of individual activities at each patient visit, as well as the total per patient budget. There should be no hidden costs for either industry or the NHS.
Why were these staff rates chosen? Historically, the APBI/BMA staff rates were widely accepted and used by both Industry and the NHS; these rates incorporated all costs including overheads. Unfortunately, as there was no clear breakdown of these rates some NHS Trusts would add an additional overhead charge on top, resulting in overly inflated prices. The new UKCRN Industry Costing Template provides a full breakdown of all costs and is based on real NHS costs. It clearly demonstrates the direct NHS costs for each activity based upon staff category, to which overheads and capacity building are then added, resulting in a final staff price. During the UKCRN Industry Costing Template Pilot, this transparent system of calculating costs was compared with studies costed using traditional methods with the ABPI/ BMA rates and clearly demonstrated that the UKCRN Industry Costing Template did not inflate prices and ensured full cost recovery to the NHS.
The overhead rate is higher than the local Trust would usually charge. Will this push prices up and make us less competitive?
No. It is essential to understand that a 70% overhead is only added to the
DIRECT NHS STAFF COST NOT to a commercial price. This rate has been chosen as a result of consultation and extensive benchmarking. A six month pilot project, looking at Network adopted Industry studies found that the majority of studies came within 5% of the expected local budget and found that local agreements were confirmed more rapidly between the Trust and the Company.
A breakdown of staff prices are illustrated below:
| Staff | Basic rate | Rate inclusive of Overheads and Capacity Building | Minimum Total hourly rate (with lowest PbR MFF) | Maximum Total hourly rate (with highest PbR MFF) |
| All Medical staff (@Senior Consultant rate) | £68.75 | £130.62 | £130.78 | £163.28 |
| Nursing staff | £25.87 | £49.15 | £49.21 | £61.43 |
| Other professional staff (eg pharmacists) | £25.87 | £49.15 | £49.21 | £61.43 |
| Admin/ data management | £11.79 | £22.40 | £22.42 | £28.00 |
Why are overheads not added to the Investigation Pricing Index in the UKCRN Industry Costing Template?
The price of investigations in the Pricing Index were derived through a benchmarking process from more than 25 Trusts, using provider to provider prices for NHS services. These prices already include overheads, however the capacity building multiplier and the PbR MFF are added by the UKCRN Industry Costing Template.
What is Capacity Building used for? A capacity building rate of 20% is automatically added to direct staff costs and investigation prices. This funding will be ring fenced by NHS Trusts to support local research activities.
Will every NHS Trust be paid the same amount for a study? It would be unreasonable to expect every NHS Trust to have identical costs. The UKCRN have addressed this variation by adopting the Payment by Results Market Forces Factor (PbR MFF) system of measuring costs for NHS service delivery, developed by the Department of Health.
The total per patient budget is multiplied by the PbR MFF for each participating Trust and a local price is calculated. The appropriate PbR MFF multiplier for each Trust can be found on a drop down menu within the UKCRN Industry Costing Template.
TCRN adopted Industry sponsored studies were used to pilot the Costing Template, however when multipliers over 1.25 (i.e. those relating to the inner London NHS trusts) were added to the final price in the UKCRN Industry Costing Template the resulting sum was considered too high by companies. The participating London Trusts also calculated their prices lower than the price generated using 1.44 and agreed that using the maximum multiplier made inner London Trusts too expensive and therefore less attractive to companies. The UKCRN Industry Costing Template will therefore be introduced with a PbR MFF cap at 1.25 and this element will be evaluated on an ongoing basis.
The complete list of NHS Trusts with their PbR MFF multiplier can be found on a drop down menu within the UKCRN Industry Costing Template.
Further information about Payment by Results can be found here Will the UKCRN Costing Process mean there is less incentive for researchers to take part in Industry sponsored studies?
No. The rates and methodology used within the UKCRN Industry Costing Template are a result of consultation and extensive benchmarking. The UKCRN Industry Costing Template provides a tool to support NHS R&D and finance departments in their allocation and reimbursement of funds to researchers and departments supporting research. This cannot be dictated by UKCRN and agreements for funding flow between researchers and the Trust must be decided at a local level.
Will the Network receive any of the fees included in the UKCRN Industry Costing Template? Not directly. The UKCRN Industry Costing Template will inform the financial arrangements documented within the Model Clinical Trials Agreement (mCTA), which Trusts will continue to hold with companies. All identified fees will therefore go directly to the site Trust. Local arrangements and Service Level Agreements should then be agreed between Trusts and Local Research Networks to then transfer the cost of any Network Research Nurse time used. This will not include overheads or capacity building funding.
What happens if the site’s Trust disagrees with the price of a study? The UKCRN cannot set a fixed price for NHS Trusts. However the UKCRN Industry Costing Template has been developed to support rapid local costing negotiation and agreement with sites. Once the study is adopted and the site is confirmed by the Company, the Local Research Networks will provide their sites/Trusts with the UKCRN Industry Costing Template, obtain any feedback or requests for amendments to the proposed costing and provide clear reasons for any changes.
Reasons for amendments might include:
- Insufficient staff time allocated for a particular activity
- A study specific activity missing from the template
- A local requirement to conduct aspects of the study out of hours (e.g. limited availability of equipment)
This will mean that negotiations will be focused on activity rather than prices.
Do we have to use the Costing Template for UKCRN Industry Adopted studies? Yes, the UKCRN Industry Costing Template is an integral part of the Industry study adoption process and will form the basis for any discussions around study fees for UKCRN adopted Industry studies in the NIHR Networks.
Is there any help or advice available about the UKCRN Costing Process? There are UKCRN courses on ‘Working with Industry for Site Staff and also LRN Managers’ which include sessions on the Costing process. An email address has been set up to answer any questions or difficulties you may be having
costinghelp@ukcrn.org.uk or please call the UKCRN Industry team for further advice 0113 343 0341
Is there any way I can feedback on what is or isn’t working within the UKCRN Industry Costing Template?
All elements of the UKCRN Industry Costing Template will be closely monitored over the first 12 months and amendments will be made when required. If you have any concerns, suggestions or points you would like us to investigate then please email us at
costingfeedback@ukcrn.org.uk How can the Networks help? It is important that Network Staff work with the new process and highlight any difficulties they encounter in using the UKCRN Industry Costing Template to their relevant Network Coordinating Centre. Ultimately the Costing negotiation and Trust agreement will be facilitated by the Comprehensive Local Research Network staff for all Industry studies, however the Topic-Specific Networks will be asked to support negotiation with Trusts during the NIHR CCRN implementation period. We will be looking to highlight successes as well as resolve difficulties.
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