Author: Gabrielle Flora, Associate Director, BRC
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Globalization of clinical trials has placed new demands on samples and data management in decentralized biobanks. The rapid advance of technology raises questions about use, consent, storage, generation, and tracking of samples. Best practices are emerging to shape this new landscape and the need for a regularized approach to biobanking has become evident.
Three variables critical to next generation biobanking are: data management and exploration; virtual biobanking; and operational biobanking. Understanding the relationship between these is critical to the evolution of next generation studies. Furthermore, clinical research needs to be reproducible for global use, making the need for consented samples of high quality and high annotation essential.
“Biobanking used to be simple,” says Dr. Jian Wang, CEO of Biofortis, Inc, a software solutions company for researchers to help access and utilize data in discovery. “Now, there is a lot of externalization and a lot of collaboration. This is especially true of precision medicine. You need to be able to extract the correct information and codify that information. Because reality is very messy compared to the plan. It’s important to be able to work with data and not just receive data,” he says.
The BioPharma Research Council’s (BRC) recent broadcast presented both Dr. Wang and Amelia Wall Warner, PharmD, RPh, CEO & President of Global Specimen Solutions, Inc, an innovative specimen management clinical research organization.
“In point of fact, in recent years the concern hasn’t been around use of specimens but around use of data,” says Wall Warner. “What is the actual risk to our population if we allow this individual’s sample to be analyzed? Do we trust companies that are coming and using our data to do it in an ethical way? Do we need to analyze parts of the genome that were not part of the original analysis as a global service? When we are enabling clinical trials, being able to make decisions based on data rather than as a reaction to operations is important.”
She outlines key concerns as: tracking samples as soon as possible for accuracy; making diligent notes on collection; specificity about location of collection; and precision in descriptions of collection frequency and cohort representation.
“The advent of precision medicine is making this problem a must instead of an optional problem to solve,” says Dr. Wang. “It’s about what you can do with the samples in your biobank. You need to be able to clean your data so you can work with your data.”
“Specimen-based research is obviously very important,” said Wall Warner. That importance continues to grow, making next generation biobanking critical to global research.