Feasibility: Ask clinical and delivery experts to review your protocol
Get help to confirm your research plans are viable in the UK. This free service is designed for commercial sponsors to support your feasibility processes. We will help you to access relevant clinical, care and research delivery experts to advise how to optimise your research for delivery in the UK health and care system.
Benefits of using this service
- Efficient: minimises the resource required to identify the right experts
- Fast: receive feedback in 10 working days
- Reliable: information relates to current clinical practice
- Pragmatic: sense checking your protocol now can prevent delays later
- Free: all our Study Support Services are free. Learn why this support is free.
When to use this service
We advise all commercial sponsors to use this service before you submit for MHRA and HRA research approvals. This is an essential step in the feasibility process for any study being delivered in the UK. It is especially important if it is a multi-country trial, or if the protocol was written outside the UK.
Get help to develop your protocol
If you are still in the planning stage, or yet to finalise your protocol, we can help you to optimise your protocol for delivery in the most suitable health or care setting and patient population. Acquiring this input at this early stage will help you to develop a protocol that can be delivered quickly and efficiently.
We have a national national network of NIHR-affiliated experts and clinical key opinion leaders (KOLs) working in all therapeutic areas throughout the NHS and wider care environment. We can identify and engage relevant experts to discuss your proposed research. This will include information, advice and guidance on your chosen therapeutic area, for example:
- patient care pathways
- current clinical practice
- potential recruitment strategies and challenges including digital engagement options
This expertise and insight is essential if you are not familiar with the UK health and care environment. You may need to work collaboratively with our experts. Consequently, the duration of this support will vary depending on your requirements.
Get expert feedback on the feasibility of an existing protocol
If your protocol is already developed, we will quickly and efficiently engage relevant UK experts to check that your study is compatible and deliverable in the intended health or care setting and patient population.
The timeline for receiving feedback is 10 working days.
Similar to above, we use our national network of NIHR-affiliated experts and clinical key opinion leaders (KOLs) to acquire expert feedback on your proposed protocol. We include partner organisations in Scotland, Wales and Northern Ireland in this process.
Our experts will feedback on aspects that may affect successful delivery such as:
- study complexity
- compatibility with UK clinical practice
- patient populations
- recruitment strategy and setting
- time lines
- potential impact of competing studies across the UK
You can also add specific questions for feedback, such as, testing the validity of your exclusion and inclusion criteria.
The clinical and care experts providing feedback may also share their contact details as an early expression of interest to become an investigator for your research.
If the feedback indicates your protocol is not viable in the UK, at your request, we will endeavour to connect you with clinical and research experts to advise how to develop your protocol for delivery in the UK (as above).
What happens if I decide not to use this service?
We recommend that commercial sponsors use this service to check if your research is viable, as it may help prevent issues occuring that could result in our support being withdrawn.
If you choose to not use this service, and your protocol contains aspects that are not compatible with UK practice, there is an increased risk that your study will be difficult to deliver and experience delays.
The studies we support must have clear value to the NHS, as explained in our Eligibility Criteria. Studies that are not progressing can have a negative impact on NHS capacity to deliver other research. This can result in a breach of the Eligibility Criteria and NIHR support may be withdrawn. This approach enables resources to be reallocated to ensure the flow of research participation opportunities to patients is maintained.
In the UK new measures (.PDF) have been introduced which help us to work collaboratively with sponsors to monitor the progress of your research.
How to request this service
You will need to provide basic information about your study protocol (which will be covered by our confidentiality agreement). Contact our Industry team for advice if you are using NIHR services for the first time.
If you have used our services before, use your account details to log in to our Central Portfolio Management System (CPMS) and request our 'Early Feedback' service. Alternatively, read our 10 step user guide for our Study Support Service to learn how to access this and other services.
Further feasibility support from the NIHR
Get patient input and feedback on your study design
Our Patient Engagement in Clinical Development Service has been created for the life science industry to help you to engage directly with patients, members of the public and carers. Their feedback will help you to ensure your research design is participant-friendly.
Use our research activity data to inform your feasibility process
The NIHR is the only organisation which collates real-time research activity data from across the UK. It helps us to understand and optimise all the capacity in the system to deliver research quickly and efficiently. Learn how you can use this data to support your study feasibility, planning and placement.
Help to identify investigators and sites for your research
Our UK-wide site identification service enables you to quickly gather expressions of interest from potential sites and investigators for your study.
Query our research registries
Digital engagement tools such as the Be Part of Research registry and Join Dementia Research registry can help us to understand public appetite for research opportunities in specific conditions. These tools can also help promote your study to participants, and directly support recruitment.
The NIHR Study Support Service
Some of the services described here are part of the NIHR Study Support Service - a specific set of these tools and support to help you plan, place and deliver research. This helpful explains how to access the right support, at the right time.
You may also find our Life Sciences Industry Learning Centre on NIHR Learn useful. It contains resources that will help you to understand and optimise support available via the NIHR Study Support Service. Log in to NIHR Learn with your existing Central Portfolio Management System (CPMS) details, or create a CPMS account.
Explore more support from the NIHR
This service is just one of the ways we help life science organisations. Visit our NIHR support for industry page to discover our full range of support or explore all our services and support.
Suggested content
Customers also viewed:
- 10 step guide: Study Support Service for the life sciences industry
- Life Sciences Industry Learning Centre for the Study Support Service (on NIHR Learn)
- Patient Engagement in Clinical Development Service
- Access research activity databases to help plan your trial
- Identify investigators and sites for your research
- Recruit participants using our digital engagement tools
- Case studies of our support for industry
Contact the Industry team
Fill out our contact form to request a chat with our team. We aim to reply as soon as possible and always within two business days.