Digital Measures – Is it Validated?
Part Two

If you missed it, you can read part one here.

By Stephanie Sargeant, Commercial Manager

We know the use and impact of digital measures, biomarkers and endpoints continues to explode. The terminology itself can be confusing and difficult to navigate. Depending on an individual’s involvement in the trial, stakeholders may still not always be making the correlation when selecting wearables within trials, for the importance of thinking the trial data through to the end.

Selection teams may get deterred with wanting to include every sensor type because it’s available at the cost of long-term wear and validated data – topics we continue to educate on within clinical trials. Yes, adherence and compliance are vital, but when we cut to the chase, the technology selected is a means to an end – it’s all about the data! In selecting the appropriate technology it’s therefore key to consider:

• What is the objective of the trial?
• What are you trying to achieve?
• What are the most insightful measures available for both patient and clinician?
• Then, the big one – are they validated?

Asking about validation can be a loaded question, the industry needs to be clear about what it means and is trying to achieve here – we often see a disparity in the expectations of study design teams with the readiness of off-the-shelf, validated algorithms. The sector is evolving rapidly in terms of the implementation of digital measures within clinical trials and open-source algorithm development, along with the approach from regulators such as the MHRA and FDA, who have recently released guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. When combined with the nuances of different population groups, therapeutic areas and digital measures are considered – there’s still a long journey to go on.

In the meantime, Activinsights remains committed to leading the way in objective digital health measurement. Keeping it simple and accessible with a clear pathway to validation, alongside ongoing algorithm development for relevant digital measures across therapeutic areas. We’ve identified over 150 digital measures we regularly use in data analysis – watch this space for more information coming soon here!

There is a clear route being formed on more readily available, validated digital measures using ‘off-the-shelf algorithms’ alongside the need for ongoing algorithm development to identify novel measures, specific to population groups. This can often be done in parallel to a clinical trial. As digital health measurement experts, it’s our job to support study trial design, scientific and digital biomarker teams with trials co-coordinators to navigate this space. Combining easy deployment, relevant, meaningful and validated digital measures to improve study efficiency and novel insights outside the clinic with remote patient monitoring.

Be patient – as an industry, it’s on its way!