It is critical to think through and establish the evidence base required for your product or service in clinical practice at an early stage.
This may vary from observational or questionnaire based research, through to full randomised controlled trials, (RCTs). Firstly, distinguish between ‘research’ and ‘clinical trials’. Not all research requires approvals, and knowing this will shorten development timelines. Resources on the HRA website can help in clarifying the differences.
The National Institute for Health Research (NIHR) brings together top UK universities and NHS hospitals to carry out world-class translational research. The NIHR Infrastructure has x7 sub-sections. A coordinating organisation, known as NOCRI, can help you understand whether you need clinical trials or not, and sign-post you to the relevant part of the NIHR infrastructure. NOCRI should be your first port of call when thinking about building your clinical evidence base.
When reaching out to NOCRI, it is important to think about:
- What type of support are you looking for? e.g. collaborative research (with clinical academics), commercial contract research (fully commercially funded), study development, market access, regulatory approval, pre-clinical studies, biomarker development…
- Who are the relevant experts?
- What research questions are you looking to answer? Within what timeline do you need to deliver the research?
- Do you have funding available for this study? If not, what funding routes have you considered?
If you can answer these questions, you may want contact NOCRI by email at email@example.com, or call them on +44 (0)20 3794 7381 for initial guidance.
The NIHR offer the following funding opportunities for digital health solutions (note that time-scales are not adjusted for digital, and these processes can be considered quite slow. Early engagement is encouraged to help combat this issue):
- Invention for Innovation (i4i)
- Healthcare technology assessment (HTA)
- Efficacy and Mechanism Evaluation (EME)
For examples of successful studies, search NIHR journals for the word ‘digital’.
c/o: Health Innovation Network
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