It is vital to evaluate your formal pilots and trials to generate evidence to validate the clinical, patient and economic value of your product or service. However, it is important that you evaluate and generate evidence proportionally.

So how do I do it?

A good place to start is using the regulatory guidance and frameworks, along with discussions with healthcare professionals and payers, to understand what level of evidence is needed – such as target population, number of participants, type of experimental design and so on.

Any pilot or trial will need a clearly defined, objective protocol to provide a basis for procurement decisions. The first step in any successful pilot is the agreed basis on which the pilot is conducted and that includes the time it will take, and the outcome it will provide.

With more formal trials it’s generally more straightforward, as by definition a trial, properly conducted, has a protocol that has defined outcome measures. The key within a trial is the purpose of the trial, defining the scope and the target outcomes you are trying to achieve. The NIHR’s study support service will be able to assist with this, as will clinicians with a research background.

Conducting your trial in a formal, rigorous way will also help to lay the foundations for a successful health economics argument.

Access to clinical studies and trials:

The terms clinical trial, clinical studies and clinical investigations are frequently used interchangeably, and indicates research using human subjects.

Clinical studies may be required from a regulatory perspective but they are also increasingly seen as essential to develop the evidence required for reimbursement and adoption by NHS organisations and providers.

The NIHR infrastructure locally and nationally is designed to help facilitate start-up and SME access to trials, with NIHR Office for Clinical Research Infrastructure (NOCRI), Medtech and diagnostic co-operatives (MICs) and your local arm of the Clinical Research Network all able to help support and signpost you along the way.

Funding for trials:

The regulatory guidance and frameworks for medtech and digital health products increasingly emphasise the need for a minimum of observational or quasi-experimental studies demonstrating safety and effectiveness of the products or services.

However, clinical studies and trials are not necessarily free for commercial organisations and this can be difficult to manage for start-ups and SMEs. Luckily there are funding mechanisms available that can help address this gap: