5 questions SMEs should ask about clinical trials and regulations

How do you ensure that your innovation is safe and effective and that you can demonstrate this to payers, practitioners, regulators and the patient? It’s all about generating the right evidence whilst developing your innovation, and getting the right clinical and infrastructure support to carry out the research.

As we know, the digital health space is fast-moving and needs are continuously evolving.  The organisations that are responsible for providing research expertise and regulation are also transforming to meet the needs of digital innovation.  I recently chaired a workshop with DigitalHealth.London to connect innovative SMEs with key research and regulatory organisations, such as National Institute of Health Research (NIHR) and NICE, to help them navigate the clinical trials and regulatory landscape. This was also an opportunity for the organisations to understand the challenges SMEs face and develop their guidance in line with this.

Here are five questions companies should consider about clinical trials and regulations:

1. Is my innovation a medical device?

Daniella Smolenska, Regulatory Affairs Manager at the MHRA expressed the importance of finding out if your healthcare app or software is classified as a medical device. The MHRA has guidance to help you identify this and make sure it is safe and complies with regulations.

Their updated guidance helps developers to navigate the regulatory system so they are aware what procedures they need to have in place to get a CE mark and what their reporting responsibilities are if things change or go wrong.

2. Does my innovation require research or clinical trials?

SMEs can often be under the impression that randomised controlled trials are mandatory in their development plan. However; this may not be the case and is dependent on the research question that they are trying to solve.

Will Bowen from the Health Research Authority (HRA) shared some resources from the HRA website which can help to clarify whether research or clinical trials are needed.

3. Does my research require approval?

Often companies think that all new innovations must have approval by the Medicines and Healthcare Regulations Agency (MHRA) but this might not be necessary. Check with the MHRA or HRA at an early stage, so you can adjust your timelines accordingly. If you are conducting a clinical investigation for CE Marking you should follow the MHRA’s guidance:

https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device

4. How can I found out where to get the clinical expertise and infrastructure to help generate evidence?

The good news is that there is a lot of free support out there! The National Institute of Health Research (NIHR) invests approximately £1 billion/ year to fund personnel and facilities for clinical research and the NIHR Office for Clinical Research Infrastructure (NOCRI) helps to connect industry to the infrastructure for evidence generation through the research pathway.  The NIHR Diagnostic Evidence Co-operative (DEC) in London has the expertise to support diagnostics through the evaluation stages of development.  You can also get in touch with MedCity and we will be able to guide you in the right direction.

5. How can NICE help me?

NICE provides assistance with market access and scientific advice. If you need support developing a robust evidence base, in particular economic argument and value proposition get in touch with NICE early in your technology development. Although not all their guidance is free, they will be able to signpost you to sources of information that you need to consider to develop a good economic argument.

Sheryl Warrtig, Technical Adviser at NICE, also invited the cohort to give them feedback on the educational resources that NICE are developing which provide advice on ‘what good looks like’ for generating evidence for health apps.

Find out more here: https://www.nice.org.uk/about/what-we-do/office-for-market-access.

We hope that this helps entrepreneurs to understand what support different organisations offer and the tailored advice that is available to them. For more information about MedCity, please go to: http://www.medcityhq.com/.

As COO at MedCity and also the lead for clinical trials, I was asked to work with DigitalHealth.London Accelerator and write a blog on the ‘Evidence Workstream’ to help digital entrepreneurs know ‘what good looks like’ with respect to evidence and also to give clarity on the infrastructure available to generate it.