Commentary|Videos|July 29, 2025

Growing Excitement Around Biomarkers in Clinical Trials

In this video interview, Michael Miller, chief operating officer at Quanterix, discusses how the use of biomarkers is expanding beyond exploratory endpoints to inform efficacy and patient selection, driving improved outcomes and greater efficiency in clinical research.

In a recent video interview with Applied Clinical Trials, Michael Miller, chief operating officer, Quanterix, discussed how the clinical research industry is increasingly integrating biomarkers. Biomarkers are particularly beneficial in neurology, where advancements in imaging and blood tests have improved trial outcomes, and in oncology, where multiomic approaches and protein tissue imaging aid in matching therapies to mutations. Synopsis professionals should focus on the biomarker's purpose, technical requirements, and regulatory compliance. Platform trials and biomarkers are also driving accelerated drug approvals. These advancements are crucial for biopharma companies navigating the shift between private and government-funded research.

ACT: Where does the clinical research industry currently stand with biomarker integration? Is it becoming more popular, is there hesitancy around it, excitement, etc.?

Miller: I think there is a lot of excitement about biomarkers in clinical trials right now, and a lot of that stems with some of the new uses. Currently, a lot of trials do include biomarkers. Today, many of them can be used for exploratory purposes or exploratory endpoints, but the real action, or the real excitement is around biomarkers starting to be used to understand the efficacy of the drug or to help understand selecting the right patients to be enrolled in a trial for a particular drug. Why is there excitement? Excitement is because that can make the clinical trial outcomes more successful and make the clinical trials more efficient, in terms of you're getting the right patients on the right drug, seeing better efficacy in those patients.


Related to this article

Where the Industry Is Headed as Clinical, Operational, and Real-World Data Connect
In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, describes the industry’s trajectory toward a unified intelligence orchestration environment—and explains why the future isn’t one model that knows everything, but a trusted system that brings the right evidence to the right human decision.
What Expanding AI Ecosystems Mean for Sponsor Complexity and Oversight
In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, argues that CROs must act as orchestrators rather than aggregators—and that the real test of any AI ecosystem is whether it reduces sponsor coordination burden or just hands it back to them.
Where AI Governance in Clinical Development Falls Short
In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, identifies three recurring failure modes in AI governance frameworks—and explains why responsible AI must be an ongoing operating discipline, not a one-time approval gate.
© photon_photo - © photon_photo - stock.adobe.com
Standardized measurement across five oncology centers found that clinical research coordinators rated eSource-enabled workflows positively (Overall Mean Satisfaction 5.79 of 7), with reduced manual entry and electronic data transfer earning strong marks, while perceived reduction in sponsor and monitor queries lagged as the one domain below threshold.