FDA officials aim to stop misuse of the term ‘digital biomarker’

Regulatory NewsRegulatory News | 29 March 2022 |  By 

While a lot of researchers claim they are capturing digital biomarker data, they may in fact be collecting clinical outcomes assessment (COA) data according to some US regulators. To clarify the differences, top US Food and Drug Administration (FDA) officials have defined digital biomarkers versus other kinds of data in a new article.
According to FDA officials in an article published on 25 March in npj Digital Medicine, a digital biomarker is “a characteristic or set of characteristics, collected from digital health technologies, that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions.”
The authors of the article include FDA’s Anindita Saha, Michelle Tarver and Bakul Patel. The lead author is Srikanth Vasudevan, who also worked for FDA until June 2021 but now is a senior program manager at Amazon Diagnostics.
Over the past decade, there’s been an explosion of digital health technologies (DHT) that has led FDA to come up with new guidances, launch its Digital Health Center of Excellence and pilot a new pathway for digital health products called the precertification (pre-cert) program.
The boom in DHTs has also led researchers looking to use such technologies to conduct clinical trials, especially as the COVID-19 pandemic has forced them to think of creative ways to keep studies going remotely. Most recently, FDA published a draft guidance on how DHTs can be used to remotely run clinical trials; a possible foreshadowing of a new reality. (RELATED: Stakeholders want more clarity about devices used for remote clinical studies, Regulatory Focus 24 March 2022)
But the new technologies have also created ambiguity for researchers that FDA wants to clear up.
“With the shift to digitization in healthcare, the term ‘digital biomarker’ has been increasingly used to describe a broad array of measurements,” the authors write. “There are currently multiple definitions of the term digital biomarker reported in the scientific literature, and some seem to conflate established definitions of a biomarker and a clinical outcomes assessment (COA).”
“Conflating the terms can hamper communication and evidence expectations between medical product developers and regulators,” they added. “Therefore, a clear definition of the term digital biomarker could potentially facilitate the effective use of a DHT in the evaluation of a medical product, potentially increasing patient access to safe and effective medical products.”
To help researchers understand the difference between digital biomarkers and other kinds of data, the article provides several examples, including capturing data from a pharmaco-dynamic/response biomarker, a monitoring biomarker and a diagnostic biomarker such as the Apple Watch used to collect heart data to indicate if a patient is at risk for atrial fibrillation.
The authors also include a table with examples of when a DHT can be considered providing digital biomarker data versus when it’s collecting COA data such as certain physician questionnaire data. One such example is the Kansas City Cardiomyopathy Questionnaire COA data which FDA has previously qualified as a medical device development tool (MDDT) to help researchers streamline their clinical trial process.


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