Protocol development and feasibility review
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
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 we 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).
First time user?
Contact us for advice if you are using NIHR services for the first time:
Already used this service?
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 guide for our Study Support Service to learn how to access this and other services.
Related services
This service is just one of the ways we help life science organisations.
Life Sciences Industry Learning Centre
Our Life Sciences Industry Learning Centre 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.
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Contact the Industry team
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Contacts for specific sites or studies
If you need help with a specific site or study that is already underway, contact your local or lead site support team: Regional Research Delivery Network contact details for life science industry