Ensuring Proper Standards for Biospecimen Collection and Sample Tracking

In a recent video interview with Applied Clinical Trials, Mark Melton, vice president of biospecimen data and operations, Slope, discussed navigating data challenges in clinical trials, emphasizing the need for understanding complex data sources and ensuring a proper chain of custody for samples. Melton highlighted the importance of data mapping to standardize reporting across different labs and the necessity of secure data transfer to protect patient privacy.

A transcript of Melton’s conversation with ACT can be found below.

ACT: What are some of the operational challenges with biospecimen collection and sample tracking? How can they be addressed?

Melton: I think the biggest part is, again, understanding the multiple stakeholders. For me, I always try to go back to 30,000 feet of if I was someone in a clinical trial, I want to understand, hey, I'm coming in, I'm giving my blood or my tissue or whatever it may be, depending on the therapeutic area. I think there's often an assumption when we all go to the physician, but particularly in clinical trials, I don't think it's really well understood by the public how those are handled. The biggest part is everyone understanding that, hey, we have a location, clinical sites that collect those and again, they send them out. How do we ensure that it's interconnected, regardless of the fact that we have multiple different companies facilitating one process, so you can imagine, even in one company, it's difficult to align on process and ensuring that we're hitting that.

The biggest thing is understanding what happens at sites. If we were to break this down, there's only a certain number of facilities that will test samples, while there may be a few hundred, it’s nothing in comparison to the sites, which are in the thousands, tens of thousands even globally. All of those sites are networks, sometimes they're independent entities, but understanding what their process is. They're the point of origin, so how can we ensure that they're collecting those properly? That starts with down to the inventory, so we send out all this inventory. If you can imagine, if you're a large cancer site, for example, I'm running 600 trials. I'm just making up a number, but I'm running hundreds of trials, and all of those trials are sending me, essentially material to collect those samples. How do we manage that material and then turn that material into blood or tissue or whatever sample type, and get it out? Then how do we track that through the life cycle? What we've done is kind of crazy. The science has gotten so specific, so the concept of precision-based medicine, meaning we're going to target a specific gene or protein, the science has gotten very specific and has advanced tremendously. It's outgrown the logistics of a trial which is kind of crazy to think about, that the science, and in my opinion, the hardest part, has somehow gotten to the point where we're getting very specific in what we're targeting. Yet the process of just tracking a sample from one location to the four or five other it touches is extremely difficult. It's interesting at the end of the day, if you look, regulators are coming in and now stepping in on how you test those samples, but the gap we have right now is they're not stepping in on how those samples are tracked and reported on. I think that that's the biggest thing we have to focus on, collectively as an industry, is, how do we step in and ensure proper standards to ensure a proper chain of custody?