Using data from digital health technologies is making it possible to measure the performance of investigational treatments more rapidly, completely, and accurately than ever before.
What’s a digital biomarker?
Biomarkers are, literally, “biological markers” – defined characteristics measured as indicators of a process or a response in the body (for example, blood pressure in hypertension). Digital biomarkers, however, are objective, quantifiable measures that can be used as indicators of a process or response in the body, once their relationship to an existing, validated endpoint has been established. These measures are derived using digital health technology (for example, the pulse rate or step count from a wearable device) and can be used like biomarkers in clinical development — to indicate a response to an intervention — once their correlation to a measurement construct or another established biomarker is proven with evidence generated in studies.
One metaphor for the wealth of information that digital biomarkers offer is: if a traditional biomarker offers a camera snapshot of your health, digital biomarkers are like HD films.
And digital biomarkers are transforming clinical trials.
Why? How? Why do digital biomarkers matter so much?
Biomarkers in general enable, accelerate, and increase the efficiency of drug development. When researchers have measures they can use and trust, they can study treatments to determine how well they work. Without sensitive biomarkers, study sponsors may not know if their investigational drug is working — investing millions into a drug that isn’t working or, worse, giving up on a drug that was working but wasn’t showing a clear enough signal.
And digital biomarkers are especially important for sponsors of clinical research. As my colleague Hiro Mori has noted in “Project Moneyball” (his work to quantify the effects of clinical trial technologies), using sensitive biomarkers can reduce both the necessary sample size as well as the trial duration.
To sum it up, as our Chief Medical Officer, Dr. John Wagner, recently told Forbes, “Digital biomarkers are revolutionizing clinical research and the practice of medicine, every bit as impactful as pharmacogenetics or circulating cell-free tumor DNA biomarkers.”
So how is digital biomarker innovation happening?
Digital biomarkers super-charge drug development by giving researchers and leaders what they need to make better decisions. To make this possible for more studies, we need to work together.
Fortunately, this is happening in quite a few different ways: there are peer-to-peer, pre-competitive collaborations among pharmaceutical companies; there are collaborations between pharma and technology companies; and there are multi-organization collaborations among various organizations.
Here are a few examples of important collaborations between world-class organizations and institutions. In many cases, they’re working to validate digital biomarkers. That matters because of the trustworthiness and precision that drug development requires. From the sensors in the tools, to the algorithms that process the data, to the measures that result from that analysis, every step needs to be proven to be accurate and repeatable. Validating digital biomarkers puts them on a path to equal footing with traditional biomarkers, which are known and trusted and accepted.
- The Mobilise-D consortium is working to establish validated digital biomarkers for mobility. You’d be surprised how much you can learn from the way you walk: gait and balance assessment can be useful in conditions from chronic obstructive pulmonary disease to Parkinson’s disease (PD) and more. The consortium comprises 34 research partners from Europe and the United States.
- The Nocturnal Scratch Initiative is the first pre-competitive development of a digital endpoint for use in clinical trials. This is an effort from the Digital Medicine (DiMe) Society, of which we’re a proud founding member.
- We’re honored to have been the recipient of grants from the Michael J. Fox Foundation for research that we’re doing with Northwestern University into digital biomarkers related to speech symptoms associated with Parkinson’s disease.
- Our long-term partnership with Sanofi in neuroscience research has expanded from multiple sclerosis into PD as well. We’re proud to have helped Sanofi deploy digital biomarkers into many studies.
- The Critical Path for Parkinson’s Consortium has created a global database of data on people with PD, and is working to create new digital biomarkers and trial models that can help to intervene earlier in the progression of the disease.
And I think it’s important to end by noting that most of the work that’s been done in PD digital biomarkers builds upon the mPower studies that Sage Bionetworks have been doing since 2015. Collaboration in the present is important, but it’s just as important to be learning from and building on the work that’s been done before!
To learn more about collaboration in digital biomarker innovation – specifically, in Parkinson’s disease – stay tuned for more details about our upcoming session, “Advancing Digital Biomarkers in Parkinson’s Disease Clinical Trials,” at the CNS Summit, Nov. 19, 2022!