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National Contract Value Review is a step change, not a leap of faith

Dr Pippa Corrie

Published: 18 May 2023

Dr Pippa Corrie is one of the UK’s leading consultant oncologists and clinical researchers. She is the NIHR National Specialty Lead for Late Phase and International Cancer Trials and also chairs the NIHR Cancer Specialty Group. As chief investigator of several melanoma and pancreatic cancer clinical trials, Pippa has extensive experience of leading both academic and commercial-sponsored research.

On 1 October last year (2022) National Contract Value Review (NCVR) was implemented across the UK to facilitate faster costing and contracting between commercial sponsors of clinical research (life science organisations) and NHS sites. Although this new national approach represents a significant step change, it is by no means a leap of faith, according to Dr Corrie. She explains why she thinks the research community can feel confident that this new way of costing commercial research is comprehensive, robust and reliable.

Being a researcher myself, I’m passionate about promoting improvements in the research delivery process. I’m especially keen to support initiatives that seek to increase the speed and efficiency of research and streamline the work involved, as these will ultimately expedite patient access to new treatments.

We all recognise that delays can occur in the administrative side of study-set up and, historically, the costing and contracting phase has been a particular pinch point. So when NCVR landed I was eager to show my support and contribute to its successful implementation.

To summarise why, in the past every site involved in a multi-centre study would assess the resources required to deliver the study and calculate the costs in isolation. So for one study with 10 sites, the same conversation was happening 10 times, each with slight variations in the outcome. NCVR streamlines the process by introducing a ‘do once and share’ approach. For each study the resource requirement negotiations are led by one site, usually where the chief investigator is based, in collaboration with the life science company sponsor. Once agreed, that information is then shared to all the other sites, so the trial is costed once only.

It’s a win-win situation as it saves time and resource for both the company sponsor and the NHS. However, let’s be honest, this is a monumental change in how things are done.

The key is confidence

It's understandable that there would initially be some apprehension. Getting the costings right the first time, to minimise the need for more negotiation, is crucial, and the key to that is to build confidence in the process.

That’s where I felt I could contribute - by providing reassurance that the right expertise and experience is fully embedded in this new way of working. How exactly?

Well, as many people will be aware, the UK’s interactive Costing Tool, formerly known as the ‘NIHR Industry Costing Template’, has been in use for over 15 years. Having been refined, year on year, it provides a great starting point for assessing the resources required to deliver a study at site level. But, as you would expect, this tool has some generic elements whereas there are disease-specific nuances that need to be considered in the costing negotiations. This is especially true in oncology as cancer studies can often be complex.

My contribution has been to bring clinical expertise into those conversations to ensure the new NCVR process confidently captures every single aspect of research delivery time and resource. Making certain that our NHS, a taxpayer-funded system, is fully reimbursed is paramount.

Costing conversations are crucial

One of the ways I have done this is by championing a multidisciplinary approach. This is crucial because practical participation in a trial can look slightly different from an administrative perspective, such as that held by R&D colleagues in an NHS Trust, compared to that from the clinical perspective.

The solution is to ensure all voices are heard in the costing conversation. Clinicians, lead research nurses, site delivery teams, administrative staff, and of course, the company sponsor, all need to have a say. Applying a multidisciplinary approach and capturing those different perspectives from the outset will ensure that the costing is comprehensive and no inappropriate assumptions are made. This will provide confidence to other participating sites that they can accept the central costings and also reduce the need for amendments to the costings further down the line.

To support those conversations with the multidisciplinary team we’ve created a guidance document. It relates specifically to the costing of oncology trials. It includes everything the team needs to consider and provides example timeframes for tasks in an oncology context.

A good example is the concept of principal investigator (PI) oversight - the time it takes for a PI to provide clinical and administrative oversight of the day to day running of an oncology study. It’s a crucial part of delivering a high quality clinical trial, but it’s also really time-consuming. We introduced this new concept and it is now one of the standard costing considerations. Our experience to date is that sponsors have acknowledged the need to reimburse PI oversight fairly and have accepted this new cost.

Making the multidisciplinary approach visible

Once costs are generated by the lead site, it is crucial that all stakeholders can trust the data. Making the multidisciplinary approach visible helps to build that trust. This is accomplished by ensuring all the conversation points are captured and cascaded with the approved costing.

In doing so, the recipients can see that the correct expertise is being integrated into the process and that costs have been checked and cross-checked. By accepting the costing, the teams at supporting sites can then focus their resources on getting the study up and running, a significant chunk of the administrative burden having been removed.

In addition, there is another benefit to consider, particularly for the life science companies seeking to place their studies where the best recruitment potential lies. This may mean working with NHS organisations that they have not worked with previously. The NIHR Clinical Research Network (and devolved nation equivalents) play a pivotal role here as the mechanism for sharing expertise. So if companies choose to work with a new lead site they can be confident that they will experience the same standard of service.

Another step in the right direction

We are now six months on since NCVR became operational, following the NHS England mandate, and positive signs are emerging with the average number of days to complete the resource review being well within the target 30 day period. Indeed, my first-hand experience of the process as a chief investigator of a multi-site oncology study has been positive. The company was very keen to pilot the new way of working and so far it's gone smoothly.

However, there is still work to do and the process of sites signing up to ‘automatically accept’ the approvedcostings is ongoing. This is crucial if we are to achieve our common goal of setting up studies quickly and efficiently, to reduce overalltimelines for research delivery. For those yet to commence study set-up viaNCVR, my advice is to remember that it is by no means a leap of faith, we’ve been talking about implementing this kind of approach for a long time. This is a key step towards streamlining study set-up processes and working towards having a single sign-off for multi-centre studies in the future.

Learn more about how the NIHR is supporting the implementation of the National Contract Value Review process for commercially-sponsored research.

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