Growing Excitement Around Biomarkers in Clinical Trials

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.