Standardized, carefully managed samples are indispensable for the success of any clinical study. Still, sample processing and management receive little attention.
Clinical trials studying immuno-oncology treatments, auto-immune therapeutics, cell therapies, or gene therapies use sophisticated assays to identify and measure biomarkers, as well as the effects and side-effects of these novel therapies.
These assays are highly technically complex and can provide significant insights such as understanding the status of a tumor, monitoring the immune system, and classification of responders vs. non-responders.
Generating quality data from these assays is strongly dependent both on technical expertise and on quality clinical samples. Yet, the clinical samples used in these analyses often receive far less attention. In actuality, an effective sample management program can be complex and must consider a multitude of factors to ensure the ability to generate high-quality data.
The pitfalls of poor sample management
Time-course studies require precisely timed samples, defined storage and shipping conditions, thorough documentation, active sample tracking, and shipping logistics monitoring.
“Shipping is crucial because it is subject to temperature changes during transit and shipping delays, during which samples may require replenishing of dry ice,” said Angelina Bisconte, Senior Director Translational Biology and Biomarker Development at Precision for Medicine.
“When blood samples are delayed in transit, you may lose the ability to measure an initial data point 24 hours post blood draw. For many clinical trials, this time point is critical.”
When studying rare or ultra-rare diseases, which are common in gene therapy studies, loss of samples can be devastating. Aaron Burke, Director of Marketing at Precision for Medicine, described: “We are currently engaged with a client to perform sample analysis for an ongoing, four-year longitudinal study involving only twelve patients. Every single sample in that study is incredibly precious.”
Sample quality = data quality
So isn’t it strange that we talk so much about exciting new analysis methods and so little about the samples that go into them?
Precision for Medicine started as a CRO supporting biomarker-driven, precision medicine trials. Early on, the team learned that the quality of the data they could provide to customers was limited by the quality of the samples they received from external sources.
As Burke explained: “The reality is that unless you have end-to-end control, there can be variability in the way samples are processed and managed. For example, some service providers may contract with multiple labs for sample processing. Even if the provider audits those labs regularly, it is quite difficult to ensure each lab operates consistently in exactly the same manner.”
A global sample processing network supporting precision therapeutic development
Consequently, Precision for Medicine became actively engaged in sample management and set up an integrated solution from draw to analysis. This includes the generation of sample collection kits, a network of sample processing labs, global logistics, and biostorage – all tailored to the needs of individual studies and assays.
For example, flow cytometry measurements of whole blood samples must be performed rapidly – often within 24 hours after a blood draw. In contrast, other assays will require blood to be processed into peripheral blood mononuclear cells (PBMCs) and stored at low temperatures for future batch analysis.
In the established workflow, Precision for Medicine’s optimized sample kits are delivered to the collection sites. Post-collection, they are picked up by courier for the same day or next day shipment to one of Precision’s strategically located sample processing laboratories across the globe.
All labs follow Good Clinical Practice (GCP) and standardized protocols with staff trained to ensure samples are processed in a consistent manner at every lab, typically within 24-48 hours. The central European lab is located in Berlin, Germany, where epigenetics-based immune cell monitoring services are also part of the offering.
Virtual sample inventory management
To ensure accountability and provide a complete picture of all samples, a dedicated virtual sample inventory management software monitors all relevant data: sample type, the exact time of collection, patient ID, planned analyses, and associated data.
“By collecting and tracking sample information in one centralized database, study sponsors have the best possible picture of the status and disposition of their precious samples,” Bisconte said. “In case of data discrepancies, we are uniquely positioned to reconcile what should have been collected versus what was collected, and when.”
“We scientifically engage with our clients to optimize and modify our solutions in an effort to address clinical endpoints needed in their clinical studies. Our goals are to generate data and information that ultimately help get new therapies to patients as fast as possible. An integrated solution that puts as much thought into sample management as we put into assays is a core part of that.”
As a result of end-to-end sample monitoring, customers receive not only high-quality data and results comparable across multi-center studies but also the peace of mind that precious, irreplaceable patient samples are handled with the utmost care.
Learn more about how Precision for Medicine supports precision therapeutic development.
Images via Precision for Medicine, header image via Shutterstock.com