Feasibility: Ask clinical and delivery experts to review your protocol

This free service enables commercial sponsors to access clinical, care and research delivery experts to help ensure that your study is feasible in the UK. 

Support to develop a protocol

If you are still in the planning stage, or yet to finalise your protocol, we can connect you with clinical and care key opinion leaders (KOLs) who can provide advice and guidance to develop or optimise your protocol for delivery in the UK.

We have a national Network of NIHR-affiliated experts 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 general information and advice on your chosen therapeutic area, for example, providing insight into UK patient care pathways, current UK clinical practice and potential recruitment strategies and challenges.

Our aim is to help you to develop a protocol that will be deliverable in the UK. Acquiring this expertise and insight at an early stage can prove invaluable. To access this support contact our Industry team.

Check an existing protocol is deliverable

If your protocol is already fully developed, we offer a more defined service - a quick and efficient way of engaging relevant UK experts to check that your study is capable of being delivered in the intended health or care setting.

We advise all commercial-sponsors to use this service before you submit for MHRA and HRA research approvals. This is a crucial step in the feasibility process for any study or trial being delivered in the UK, and is especially important if it is a multi-country trial, or if the protocol was written outside the UK.

Sense-checking your protocol now could prevent delays occurring later. Sometimes something as simple as targeting the wrong care setting can undermine your study’s ability to succeed.

Similar to above, we use our national Network of NIHR-affiliated clinical and care experts and work with partner organisations in Scotland, Wales and Northern Ireland to acquire feedback on your proposed protocol.

You will need to provide basic information about your study protocol (which will be covered by a confidentiality agreement). Our experts will feedback within 10 working days 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).

How to request this support

Both types of support are free. (Learn more about why this service is free.)

Contact our Industry team if you want to connect with clinical and care experts to develop or optimise your protocol.

If you are already working with the NIHR your can use your account details to log in to our study support system (CPMS) and request our 'Early Feedback' service. Alternatively you can read our 10 step user guide for our Study Support Service to learn how to access our protocol feedback service.

What happens if I decide not to use this service?

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 experience delays. In the UK new measures have been introduced which improve visibility of studies that are not progressing to planned time lines and potentially holding up the flow of research opportunities to patients. If delivery issues cannot be resolved, NIHR research delivery resources could be redirected to support studies that are considered deliverable. This ensures that we can continue to provide patients with opportunities to participate in research.