Digital Biomarkers: The Next Frontier in Clinical Trial Advancement

As the drug landscape grows increasingly competitive, it will be vital to gain an intimate, personalized understanding of how individual patients respond to medication to highlight a drug’s value on their quality of life. Digital biomarkers powered by artificial intelligence (AI) are already providing critical insights to personalize care and draw more comprehensive conclusions about a therapy’s impact. As they become more prevalent, their sensitive and objective data capture will not only change how clinical research is conducted, but also help deliver on the promise of precision medicine in the real world.

Though wearables such as smartwatches are often thought of when referring to digital biomarkers, audio and visual biomarkers captured through the front-facing camera on patients’ smartphones can provide a window into their disease progression and experience with treatment. Since most patients own and are comfortable using smartphones, this is an easy way to form a daily habit of sharing information via an app that captures biomarkers such as facial characteristics, vocal patterns, movement, and language content. These personalized insights can illuminate subtle changes in a patient’s treatment response and general health that may otherwise be missed by data collection in-between clinic visits with wearable technologies.

Deciphering the Diversity of Symptom Expression

Visual and audio biomarkers can demonstrate a trajectory of patient health over time, which may inform whether a specific medication is a good fit for an individual patient and vice versa. The level of detail provided via AI-powered digital biomarkers enables doctors to decipher diverse symptom expressions to determine how multiple comorbidities may be interacting and if a therapy is performing properly.

Audio and video measurements can also give insight into cross-therapeutic symptom areas, such as fatigue, pain, or sleep disturbances, that may reflect the impact of medication or disease progression. Combining data from digital biomarkers with other analytics like adherence data may enable clinicians to identify responders sooner, empowering them to make timely and personalized changes to patients’ care plans as needed.

Increasing a Drug’s Competitiveness in Crowded Markets

The intimate window audio and video digital biomarkers open into patients’ daily experiences with disease and treatment has the power to demonstrate new quality-of-life improvements for medications in a reliable, quantitative fashion. These measurable improvements can help highlight real-world value in areas such as cardiology to demonstrate a novel therapy’s value over incumbent standard of care.

For instance, if digital biomarkers in a clinical trial could show that a heart disease medication could restore or preserve patients’ levels of function in activities of daily living, these substantial, data-backed improvements in patients’ daily lives might help make the case for that drug’s inclusion as a vital component of patient care.

Opening the Door to a Future of Personalized Medicine

AI-powered video and audio digital biomarkers could be valuable in continuing to bring the concept of personalized medicine into reality. As technology advances, the depth of insights visual and audio digital biomarkers reveal across individual patient health and populations may bring forth a new standard of precision for both drug development and patient care.

  • Rich Christie, MD, PhD

    As Chief Medical Officer at AiCure, Rich Christie, MD, PhD, oversees the medical and scientific aspects of the AiCure portfolio. Dr. Christie brought extensive C-suite and clinical experience to AiCure when he first joined as Chief Development Officer, building on his previous experience as Global Head, Development Science and Innovation at Roche, as Vice President, External Research and Early Development at Johnson & Johnson, and CEO of Solaris Therapeutics. He received an SB from MIT, and an MD/PhD from Harvard, where he patented and developed novel optical methods for the study of Alzheimer’s disease.

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