It is critical to think through and establish the evidence base required for your product or service in clinical practice at an early stage.
DigitalHealth.London can signpost you to organisations that can support you through this process. This may vary from observational or questionnaire based research, through to full randomised controlled trials. Firstly, distinguish between ‘research’ and ‘clinical trials’. Not all research requires approval, and knowing this will shorten development timelines. Resources on the HRA website can help clarify 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 7 sub-sections. The NIHR Office for Clinical Research Infrastructure (NOCRI) is one of these, and can help you understand whether you need clinical trials or not. NOCRI should be your first port of call when thinking about building your clinical evidence base.
When reaching out to NOCRI, think about:
- What type of support you are looking for e.g. collaborative research (with clinical academics), commercial contract research, study development, market access, regulatory approval, pre-clinical studies
- What research questions you are looking to answer, and within what timeframe
- Funding routes
Contact NOCRI by email at firstname.lastname@example.org, or call +44 (0)20 3794 7381.
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’.