What Clinical Ops Teams Must Know About Biomarkers in 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: What should clinical operations professionals have top of mind when utilizing biomarkers in trials they’re managing?

Miller: I think that the first most important thing to think about in terms of when including biomarkers in a clinical trial is what is the purpose of the biomarker, and the reason why I say that is that that's fundamental to then understanding what are the technical requirements of, let's say, an assay or a technique to measure that biomarker, and then also what are the regulatory requirements around the use of that biomarker. I'll give you an example. We've done some work for customers where we'll be measuring a blood biomarker to help understand who should be enrolled in a clinical trial, and when you use a blood biomarker to decide who might be excluded from a trial, that's considered a medical decision, so this is up to the pharmaceutical companies or the clinops people to decide whether this applies or not, but I'm just giving you an example. That then puts a higher level of regulatory requirement on the validation of the assay, the evidence behind the assay, and its use. A vendor like Quanterix, we routinely do that within our accelerator lab for customers, and so the clinops people should think carefully about, ‘Hey, what is the purpose? How's this going to be used?’ because there may be regulatory requirements. I think you had mentioned earlier about hesitancy. I think this is where it can cause some hesitancy because it sounds complicated, but there's plenty of people who can help customers through that process, as I mentioned, we've done it.

Further that relates to where I've talked about purpose that gets to technical requirements. What's the sensitivity of the assay? How is it validated, the regulatory requirements? Then that then leads you to, ‘Hey, who should I partner with to help me measure this biomarker?’ and again, the regulatory and the technical requirements will help with that selection, because then you're like, ‘Oh, here's what I need to measure. Here's the regulatory framework you need to operate under the quality system, for example.’ If you want to submit your results to the FDA, you need to have custody of sample, data integrity, and auditability of the results, so you want to work with a partner who can provide you that. As I said, Quanterix is one of those partners.