Creating a Global Standard for Data Sources

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: How can sponsors better navigate some of the current data challenges in clinical trials?

Melton: If there was one area I would challenge the industry in, it’s ensuring that as quickly as possible, that we have the ability to, number one, establish a chain of custody, but number two is also, how do we ensure inside that chain of custody that the data that's being reported out before the sample is ever tested to give a result for whatever that assay or test may be, so all the data leading up to that is accurate. Right now, the biggest challenge in the industry is the fact that with these different data sources, they have different databases that report differently. Imagine you have six labs that speak different languages. How do you translate that? There's a concept called data mapping where you ingest that data, you map it to a common language, and then you're able to compare it. I think that's the biggest area that we have to regulate. We have to ensure that regulators are recognizing this problem, like the FDA, EMA, or whatever other governing bodies throughout the world, that ensures a standard, and right now we don't have a standard.