Laboratory data collection and management in clinical trials are becoming increasingly complex, especially in multicenter or biomarker-guided trials. As trial sponsors, whether academic institutions, companies, or contract research organizations, continue to preserve a larger number of biological specimens for future research efforts, tracking and managing patient samples requires considerable work and coordination.
Improved sample and data management is becoming easier to accomplish with technological advances and modern digital data management processes. Read on for an overview of devices and systems used to improve efficiency in clinical trial operations.
The benefits of virtual sample accessioning
Initiating the sample journey in a clinical trial with virtual sample accessioning (instead of manual or spreadsheet-based systems) provides several quality assurance opportunities, including more complete and accurate data, greater sample integrity, and improved sample security.
One tool used for this purpose is the digital pen, like the LabConnect’s digital ink pen. This tool records subject, visit, and sample information with no need for physical laboratory requisition and samples. Users write with the pen, which contains real ink, to simultaneously fill out paper requisition forms and capture data at the point of sample collection. Encrypted handwritten data associated with the sample’s identification number is then transmitted to a digital database through a USB port.
Virtual accessioning allows the trial’s sponsors and staff to confirm which samples were collected and to check each specimen’s data and status in real time, reducing miscommunications, manual errors, and the number of queries sent to the study site.
Comprehensive sample tracking solutions
Sample tracking solutions enable research teams and laboratories to know precisely where samples are in a clinical trials’s testing process. If additional analyses are ordered, laboratories can rapidly identify the patient information, see any previous testing carried out on the sample and by whom, and easily export sample histories for further review or audit purposes.
In addition to eliminating wasted time spent tracking lost samples and their data, tracking systems record samples’ storage conditions throughout their life cycle, from collection through post-analysis retrieval. This helps ensure that a trial’s samples are secure and continuously stored under optimal conditions with the proper safeguards to ensure regulatory compliance.
The transparency and high degree of automation and standardization achieved by tracking sample systems ensure efficient logistics and improve control of clinical trial processes from a sample-centric perspective.
Examples of digital tracking solutions include LabKey Sample Manager, a cloud-hosted sample management software for tracking samples, data, and workflows, and Fluics, an intuitive inventory and location tracking solution for life sciences research labs.
What is a laboratory information management systems (LIMS)? How can investing in a LIMS help?
With the increased complexity of clinical trials and the high-volume of information collected from multiple laboratories, having easily available measurements that are traceable and logically organized is necessary for compliance.
LIMS are computer applications that consolidate all of the information about trial samples onto a single platform. LIMS can help clinical trial labs control and manage samples through their entire life cycle, including login, receipt, disposition, test assignment, calculations, and results entry. Moreover, LIMS can handle the verification of test results against stored specifications, as well as their review, approval, reporting, and distribution.
LIMS also support quality control and quality assurance programs as they enable lab managers to monitor instrument calibration, stay on top of preventative maintenance, and manage inventory, including standards and reagents.
In addition, using a LIMS creates reliable and accurate records and makes it easy to track the various tests and procedures performed on different samples. For example, LIMS capture metadata such as the equipment used for testing and its calibration status, the credentials of the analyst who performed the testing, and the standards, reagents, and solutions used for testing, along with information like lot number and expiration date.
The centralized, digital storage of sample information improves productivity, efficiency, compliance, and data integrity. Because LIMS are end-to-end testing solutions, it is best to consider all of your data needs and implement such a system from the initial stages of a clinical trial. This avoids extra resources to extract data from one system and import it into another later on.
Harmonizing local laboratory data in clinical trials
Sites may use a local laboratory for tests that inform immediate clinical or randomization decisions to ensure a fast turnaround time of participant results.
As clinical trials move to decentralized models, labs use different instruments, reagents, units of measurement, and even different references ranges. This heterogeneity sometimes makes it difficult to perform direct comparisons of lab values across different local laboratories, introducing a need for conversion methods to ensure comparability of results, consistency, and compliance with the trial’s protocol.
Laboratory harmonization aims to integrate results from different laboratories, avoiding possible bias generated by technical differences between them. This process allows laboratories to exchange results instead of samples, reducing costs and delays for a trial’s sponsor. Global central laboratories and their partners usually offer this service. They receive local laboratory reports, conduct the harmonization process, and incorporate the data into the integrated clinical laboratory database in near real time.
Tools for visual data analytics
As the volume of laboratory data collected in clinical trials expands, using tabular outputs often leads to problems in the generation, assessment, validation, comprehension, and communication of study findings. Automated data integration and visualization tools are intuitive platforms for real-time results interpretation.
Using an interactive dashboard, research teams can interact with the data and gain insights into study trends at a patient and population level. In addition to reviewing up-to-date trends of results from the clinical sample database, trial sponsors and staff can quickly identify outliers, patterns, omissions, or normalization issues, which together contribute to patient safety and improve data-driven scientific or business decisions.
The ability to create customized reports and present data in a visual and accessible format also enables those monitoring the trial to quickly recognize and address inconsistencies and discrepancies, ensuring compliance in real time. Users can share visualizations with specific team members or an entire group. Yet, data security filters prevent unauthorized access to either data or visualizations.
SAS JMP Clinical and J-Review are examples of clinical research targeted software that enable graph enhancement. These tools have functionalities that allow you to interact, animate, and drill down into the data.
Laboratory testing in clinical trials presents many challenges regarding sample collection, management, analysis, and interpretation. Luckily, technology has advanced and digital sample and data management processes have been applied to improve multiple laboratory aspects of clinical trials. Connecting all stakeholders through a shared understanding of integrated data optimizes processes, reduces clinical trial life cycle, and minimizes costs.