How to optimise NIHR support for a large-scale, late-phase trial

Planning your trial: Optimise your protocol prior to seeking regulatory approvals

Investing more time when planning your trial can prevent delays occurring later. Ideally you will contact us before you request regulatory approvals to run your trial, as this provides greater scope to optimise the support available. All you need to get started is a study synopsis or draft protocol.

I’m not familiar with the UK or the NIHR - where do I start?

Our Life Science Industry Information Service is where it all begins. This service is provided by our dedicated Industry team which has extensive knowledge and experience of the UK research landscape. We’ll provide a free, personalised consultation, tailored to your proposed programme of research. This will include information on all the support that is available from the NIHR and advice on when is best to access it. As you are just getting started, you may also find our guide to the UK research ecosystem helpful.

I want help to understand if my research is inclusive

Equality, diversity, and inclusion (EDI) considerations are important for all research. However, if you intend to enrol large numbers of participants, you will want to make sure your research is as inclusive as possible. Through our services and support we can help you to adopt inclusive approaches at different stages of your research journey. It is essential to explore these opportunities in the planning stage of your research so that you can turn your EDI intentions into actions along the way.

I need help to confirm that my research is patient-friendly

If you are planning to deliver a large-scale trial, you also need to be confident that the study activities and requirements will be ‘acceptable’ to participants. You do not want multiple sites on pause while you seek a protocol amendment for an unforeseen barrier to participation.

Our Patient Engagement in Clinical Development service has been designed to help commercial sponsors engage directly with patients, members of the public and carers. We can facilitate engagement activities to obtain patients’ perspectives on your trial protocols, recruitment strategies and patient-facing materials. Learnings from these activities will support your regulatory and ethical approval submissions to run your trial. (This service operates a full cost recovery model - it is not free).

I want clinical and research delivery experts to review and optimise my protocol

In the planning stage we can also help you to access clinical and research key opinion leaders to help develop or optimise your protocol for delivery in the UK. We work across all therapeutic areas and will connect you with experts who can advise on aspects such as care pathways and clinical practice. Our aim is to help you to develop a protocol that will be deliverable in the UK.

If your protocol is already drafted, we can check if your proposed trial is capable of being delivered in the intended health, care or community setting. If your protocol contains aspects that are not compatible with UK clinical or care practice, it may experience delays.

Learn more about acquiring feedback on the feasibility and deliverability of your proposed protocol. 

I want to access data and digital engagement tools to gain further insight into feasibility and for participant recruitment

Still in the planning stage, you now know the protocol is in good shape. But you also want to be confident that the patient populations exist in sufficient numbers for your large-scale trial.

Other questions may spring to mind, such as: Are there any other large-scale trials underway that might compete for the same or similar participants?

We have visibility of UK-wide, real-time research activity through our data and systems. We also have access to digital engagement tools which provide an indication of public appetite for research in certain conditions. These are definitely worth exploring with our dedicated Industry team to see what soft intelligence and insights we can extract.

If you plan to use our tools for recruitment when your study opens, make sure you include this recruitment mechanism in your ethics approval request.

Placing your trial: Optimise your site identification and selection

Site selections are high stake decisions for commercial sponsors. If the recruitment target is in the hundreds, or even thousands, placing your trial at the right sites, in the right locations, is crucial for success.

We understand that site selection strategies often include key opinion leaders or investigators whom you have worked with previously. However, we encourage all commercial sponsors to use our study placement support and consider looking beyond those familiar sites.

The support described below will help you identify and explore new opportunities. It also helps us to achieve better distribution of research, utilise all the capacity in the health research system to deliver research quickly and helps us to widen access to research for patients and the public.

I need to identify investigators and sites to conduct my research

Our site identification service will help you to find and engage investigators and sites for your research. Using our network structure and national systems we can quickly gather expressions of interest from investigators at sites throughout the NHS, including primary care and social care.

Ours is the only UK-wide site identification service. By using this service, you are helping to distribute research equitably; all sites nationwide have equal opportunity to express their interest in bringing your research to their patients. This includes specialist research facilities that are designed to support early-phase and intensive research and our Patient Recruitment Centres which are geared towards delivering late-phase trials.

You can still use this service if you have already identified some - but not all - of your sites.

I need help to understand which sites to select

You’ve now received 30 expressions of interest from sites across the UK. Your budget allows for 15 sites. What criteria do you apply to make your selections?

One option is to consult our national, real-time, research activity data. Visibility of this data may help you to understand which geographical regions might offer the best recruitment potential and help you to avoid hot spots where multiple studies in your target therapeutic area are already underway.

We can also compare external data sets, such as public health data, disease prevalence, and population and socio-economic data against real-time research activity data to generate intelligence to underpin your site selection strategy.

Learn more about real-time, research activity data.

I want to work with up-coming investigators - how can I find and engage them?

At this stage, you may also want to consider registering your study for our Associate Principal Investigator (PI) Scheme. This initiative provides in-work training opportunities for healthcare professionals seeking to gain practical experience in research delivery under the mentorship of existing PIs. If matched to one or more Associate PIs, your study will receive increased support at those sites. Read a peer-reviewed article which reports how the HEAL-COVID trial achieved 3.5 times higher recruitment levels at Associate PI Scheme sites.

I need access to research-ready site personnel who are Good Clinical Practice (GCP) qualified

During your site deliberations, remember that we provide GCP training to a research-ready workforce of 14,000+ personnel embedded throughout health and care services.

We also work beyond the hospital clinic supporting research delivery research in primary care, such as general practice, dentists, pharmacy as well as the wider community including care homes, schools, prisons.

If you are exploring new sites or settings, we can provide free GCP training for all site personnel delivering your research.

Our GCP training programme has been developed with the support of the Medicines and Healthcare products Regulatory Agency. It has also been added to the list of programmes mutually recognised by TransCelerate member companies, so you can feel confident that it meets UK regulatory requirements.

I need to know how much it will cost to conduct my research at NHS and general practice sites

You’re now narrowing down your list of potential sites. At this point the information available via National Contract Value Review (NCVR) - the UK’s unified approach to research costing and contracting - may help you make your final decisions.

Once you have populated the UK interactive Costing Tool (iCT) and completed a study resource review with an NHS costing expert, you will have a clear understanding of the overall cost to run your research. Perhaps your study budget will stretch to 16 sites? Or maybe you need to focus your attention on 14 sites.

If you’re looking for primary care sites, perhaps study set-up will be quicker if you work with GPs accepting NCVR prices?

Don’t forget to inform us of any pre-selected study sites - we will connect them into the UK's interactive Costing Tool for you.

Delivering your trial: Optimise study set-up and monitor progress

You have now selected 15 sites to recruit a target of 1,500 participants. We understand how important it is to open your sites quickly and commence recruitment. Once your study has regulatory approvals in place, we’ll work with you to get your sites up and running and then to stay on track.

I need to open multiple sites quickly and efficiently

Different teams will be responsible for opening your study at different sites. The NIHR works UK-wide, connecting all those sites. We will provide the mechanism for your sites to share challenges and solutions to help streamline your study set-up.

I need to identify suitable participants to take part in my research

Once you have selected your sites the local site teams will begin to identify volunteers who are suitable for your study, and who could benefit from taking part. If you have a specific recruitment strategy, for example to reach and engage the large numbers of potential participants, your site teams may work with our regional support staff. Together we will explore how we can support them to implement your recruitment strategy and achieve your recruitment goals.

If you included digital engagement tools as recruitment mechanisms in your ethics approval request, such as Be Part of Research, and other registries, at this point we can help you to activate this recruitment pathway.

How do I keep you up to date on the progress of my study?

Large-scale trials can quickly fall behind schedule if recruitment issues are not rapidly identified and resolved. Our Sponsor Engagement Tool enables you to work collaboratively with us to monitor study progress. If your study is not meeting its planned milestones on time, we will investigate and help you to understand why.