The Real-World Points of Value for Site-To-Lab Data Digitalization

The digital age for clinical trials emerged decades ago with the introduction of electronic trial submissions. Since then, electronic trial master files, patient-reported outcomes, and case reports have all found digital forms. The introduction of electronic data capture (EDC) has streamlined workflows while giving sponsors cleaner data and reducing reconciliation challenges. 

However, one integral area within clinical research that has been slower to adopt EDC is site-based clinical laboratory testing. But why? 

It is worth exploring industry-wide reasons behind this noticeable avoidance of EDC, what is being done to update the technology landscape and increase the quality of related workflows, data capture and analysis, and the key points of value. 

The burdens associated with paper-based standards

Paper-based submissions are still the standard across many clinical trials for providing patients’ personal data and sample data to central labs, despite the use of tech-enabled activities otherwise. The lack of automated and connected workflows for data collection means queries may not be generated for 24 to 48 hours after sample and data collection, which can delay query resolution. For batch shipments, raising and resolving queries may take up to a month or more, which all trickles into the broader clinical trial timeline. 

These delays often lead to downstream impacts for sites and sponsors, including holds on lab reports, prolonged data reconciliation during cleaning, and potentially delayed submission. The longer query generation is delayed, the more likely the data will take longer to confirm. 

Real-time electronic data capture: experiencing the growing value  

Industry stakeholders are beginning to realize the benefits of real-time EDC in various capacities, including: 

• Saving time and effort. Reductions in query generation are estimated to be from more than 98 percent for paper-based methods to 75 percent for RT-EDC. Query resolutions are quicker, too, with paper-based query closure rates for central labs averaging between 3 to 7+ days compared to less than two days for electronic requisition queries. 
• Real-time oversight. Stakeholders have visibility into sample data from the moment of collection. They can track samples at any time and receive on-the-spot notification of any courier delays or issues that may cause a protocol deviation.
• Cleaner downstream data and improved visibility of sample quality. Using paper requisitions to send samples directly to the testing lab instead of through a central lab often leaves central lab teams blind to the collections and data. E-requisition allows central labs to also receive the data and have full oversight of tracking from collection through shipping. 
• Potential to minimize data submissions. By reducing delays during studies and potentially shortening data cleaning and reconciliation times at project completion, EDC may help stakeholders minimize data submission delays. 

Fine-tuning kit usage to drive site-to-lab sustainability

With the push to sustainability more prominent than ever, many clinical labs strive to reduce consumption of single-use plastics during trials.  

Beyond reducing the reliance on paper via electronic lab manuals and forms, going digital also offers possibilities for kit-agnostic or bulk-kit-type capabilities. With EDC, it is possible to complete the entire collection visit with a single integrated lab application that tells sites in real-time what materials they need so they only pull the necessary tubes. Paper requisitions typically go along with pre-built kits that may contain unnecessary supplies, such as single-use plastics or tubes. Industry-wide, kit wastage can be 40–60 percent or higher, depending on the study, therapeutic focus, and site operational practices. An RT-EDC system can also prompt users to replace tubes or other items that have expired or are no longer needed due to amendments instead of wasting the entire kit. 

Electronic data also provides holistic views of inventory management systems and related sample tracking to forecast upcoming visits and kit usage in real-time with more accuracy, thus helping to reduce waste. 

Equipping sites with advanced workflow tools and support

Trial sponsors recognize that shifting to a RT-EDC should not add to sites’ burdens. When trying to reduce paper-based data collection, it is equally important to avoid increasing tech-related operational burdens, like more portals and logins. But how do you ensure that RT-EDC is not met with staff resistance? 

During trial planning, it is critical that sponsors, study teams, and CRO partners discuss the value of RT-EDC. They need to teach personnel how daily operations will improve instead of focusing on short-term transition challenges. Teams also need to provide sites with real-time support mechanisms, so they will not have to wait to complete patient visits if issues arise.  

With all necessary data in one integrated lab application, site teams spend less time identifying source paper, resolving queries and reviewing paper manuals, and no longer have to reconcile stacks of paper and multiple systems. 

Lab digitalization progress over time

Real-world use cases demonstrate a reduction in query rates from 25 percent when using paper to less than 5 percent with electronic requisitions. Fewer queries mean the time site teams spend resolving issues falls from 10 percent of their time with paper to less than 3 percent after going electronic. This lets site teams shift their focus to what matters most, providing quality care to patients in need. 

As clinical trials grow more complex, the need to improve quality and execution at every touchpoint will become more prominent. The increase in available RT-EDC applications has shown stakeholders the real-world benefits of digitizing trial activities and operations and how this digitized pathway is leading to better overall trial conduct and patient outcomes. 

The continued growth of RT-EDC will lead to the full recognition of the value of streamlining workflows and enhancing data collection from site to lab, and beyond.