Ensuring Scientific Success: The Importance of Monitoring Pre-Analytical Variables in Clinical Trials

In the high-stakes world of clinical trials, the success of translational medicine hinges on the integrity of sample data. 

Those who support translational medicine on behalf of sponsor organizations are acutely aware that the validity of their scientific hypotheses is only as robust as the quality of their patient samples and the data associated with those samples. One crucial aspect that directly influences this quality is the monitoring of pre-analytical variables during sample collection and processing.

Pre-analytical variables encompass a range of factors that can affect sample integrity before it reaches the analytical phase. A few examples include:

• De-Identified Patient Data: Variables like patient ethnicity, pre-existing conditions, and fasting status can impact what testing is performed or how results are interpreted.
• Processing Methods: How samples are handled post-collection (e.g., centrifugation, aliquoting, tissue histology) can significantly impact how they are tested, as well as their quality.
• Transportation and Storage Conditions: The temperature conditions under which samples are stored, shipped, and received at a lab before analysis can alter their properties.
• Sample Volumes: A minimum amount of sample is usually required for sample testing.
• Number of Freeze-Thaw Cycles: Many samples can only be freezed and re-thawed a certain number of times before they are no longer viable.

Monitoring these variables is critical because they directly impact the interpretation and reliability of the data that proves the science. Unfortunately, the task of tracking and managing these variables is far from straightforward.

Navigating the barriers to accessibility of pre-analytical variables

Sponsors often find themselves grappling with a lack of accessible sample metadata. This data is vital for making informed decisions about trial conduct and lab results, yet it is typically scattered across various sources and formats, often relegated to imperfect manual systems like Excel spreadsheets. This fragmentation creates significant delays and uncertainties, hindering the ability to promptly test hypotheses.

As we discussed in our recent blog, “What Is Sample Metadata in Clinical Trials?”, it helps to consider the analogy of a chef preparing a gourmet meal: the ingredients (samples) must be of the highest quality and handled with precision from farm (collection site) to table (lab analysis). Any factor that could impact a dish’s ingredients along the way — storage conditions, quantities, processing methods — can have a direct impact on the final dish. Similarly, any lapses in managing pre-analytical variables can compromise the integrity of the scientific data derived from patient samples.

Common obstacles in translational medicine that can impact pre-analytical variables

Sponsors frequently encounter several challenges related to pre-analytical variables. Unfortunately, many of these challenges may be tied to the logistics of clinical trial execution, including:

• Sample Collection Issues: Research sites might struggle with collecting certain types of samples, leading to incomplete datasets.
• Poor Sample Management: Inadequate tracking and handling of samples, particularly when they are split into parent and child samples (like aliquots and slides), can result in lost or compromised specimens.
• Complex Shipping Logistics: Navigating the logistics of shipping samples to multiple lab destinations can be a nightmare for research sites.
• Data Fragmentation: Disparate data sources and formats make it challenging to get a comprehensive view of sample metadata.

These obstacles not only delay scientific progress but also inflate costs and increase the risk of trial failure. For those under constant time pressure to deliver results, these issues are particularly problematic.

Translational medicine teams can benefit from real-time data

Real-time access to sample metadata and compliance information is a game-changer for sponsors. With immediate insights into pre-analytical variables, scientists can:

• Ensure Sample Integrity: By monitoring how samples are collected and processed in real-time, they can intervene promptly to address any deviations from protocols.
• Optimize Data Quality: Consistent and accurate handling of samples translates to more reliable data, bolstering the validity of scientific hypotheses.
• Accelerate Decision-Making: Timely access to comprehensive sample data allows for quicker adjustments to trial protocols and more precise interpretation of lab results, speeding up the overall research process.

Slope's Biospecimen360™ surfaces pre-analytical variables in real-time, empowering you to focus on the science

Biospecimen360™ is designed to meet the needs of translational medicine teams head-on. Our software provides an all-in-one solution for managing lab kits, patient samples, and sample metadata, ensuring seamless integration and real-time access to critical data. 

Here’s how we make a difference:

• Centralized Sample Metadata Management: Our platform consolidates all sample metadata in one place, eliminating the fragmentation that plagues traditional clinical trial workflows.
• Real-Time Monitoring: With our software, you can monitor pre-analytical variables in real-time, ensuring compliance and consistency across all research sites.
• Streamlined Logistics: Our platform simplifies the logistics of sample collection, processing, and shipping, reducing the risk of errors and delays.
• Enhanced Oversight: Gain comprehensive oversight into what is happening with patient samples at every stage, empowering you to make data-driven decisions quickly and confidently.

For those in translational medicine, the ability to monitor pre-analytical variables and access comprehensive sample metadata is not just a convenience — it's a necessity for scientific success. By adopting our all-in-one solution, you can ensure the highest standards of sample integrity, accelerate your research timelines, and ultimately bring groundbreaking therapies to market faster.

Ready to transform your clinical trials with real-time sample metadata? Contact us today to learn more about how our software can empower your translational medicine efforts. Together, let's unlock the full potential of your scientific research.