As digital health technologies and the biomarkers they track become increasingly valuable tools for providing insights into patients’ health in real-world settings, the authors of a forthcoming special feature for ACRP’s Clinical Researcher journal say we are witnessing a reshaping of how evidence is generated in clinical research across multiple dimensions.
Tackling the topic in the journal’s August 2025 issue, coming online soon, are Naresh Poondla, MBA, PhD, a Clinical Research Scientist at the Icahn School of Medicine at Mount Sinai; Justin Scott Brathwaite, MBA, a PhD student in Clinical Research at the University of Jamestown and a Senior Site Readiness and Regulatory Startup Specialist at Fortrea; and Milan Sheth, MS, a Clinical Research Coordinator specializing in oncology trials at Houston Methodist Neal Cancer Center. They provide examples of how digital biomarkers are revolutionizing clinical trials, focusing on their shared experiences managing trials within the fields of neurology and oncology, and examine challenges related to the use of biomarkers in clinical research going forward.
“We have witnessed a shift toward decentralized and hybrid clinical trial models that enable patients to participate from the comfort of their homes, while still generating high-quality, real-world data (RWD),” the authors note. “Electronic consent and secure data-sharing platforms have made research more efficient, inclusive, and scalable. These technologies reduce patient burden while enabling researchers to reach more diverse populations, ensuring studies reflect real-world settings.”
By combining clinical biomarkers, imaging data, and patient-reported outcomes, researchers can personalize treatment strategies more precisely than ever before, the authors add. Further, artificial intelligence-driven tools are now being used to optimize patient selection, predict treatment responses, and identify subtle patterns that might otherwise be missed in traditional trials. Importantly, real-time insights from digital biomarkers are strengthening patient-clinician partnerships, with patients becoming active participants in shared decision-making around treatment adjustments and influencing trial design.
“These innovations are accelerating the ability to test, validate, and bring new therapies to patients faster,” the authors write. “What we find most exciting is how technology is making research more inclusive by reducing the burden of site visits while offering remote participation options. Ultimately, this is the foundation of how smarter, patient-centric research is conducted and care is delivered. Therefore, we believe the future of precision medicine lies in the seamless integration of technology, RWD, and compassionate, evidence-driven care.”
The August issue of Clinical Researcher will also include a peer-reviewed article on “Healthcare is Historically Slow to Adapt to Change: Why Clinical Trials Can’t Afford it with AI,” by Avery M. Davenport, MPH, CCRC; a Good Management Practice column on “Stepping Into Leadership—What is Needed for New Managers to Excel,” by Katie Dixon, MSc; an Ethics in Action column on “Ethical Violations in Clinical Research: Recognizing, Responding, and Reporting,” by Scott W. Ward, BS, CCRP, CT-C, ACRP-CP; and more.
