In the complex web of study execution, sample reconciliation serves as one of the gateways to study success. This insight was the inspiration for the final discussion of Slope’s summer roundtable series.
On August 22nd, Slope’s Senior Director of Clinical Operations, Lauren Trull, facilitated an informative conversation with participants from various sponsors and CROs regarding their approaches to sample reconciliation.
As clinical trials become more complex, sponsors have had to adapt their sample reconciliation strategies. This was highlighted in our discussion at various points, with one attendee discussing the prior complications that her organization ran into when they used a reactive approach to manage their samples. This process often led to data management bottlenecks wherein stakeholders would be responsible for reconciling massive amounts of data at one time. Since adopting a more proactive approach that involves performing reconciliation before a sample is tested and resulted, this attendee’s organization has seen immediate improvements. Now, instead of scrambling to check on the status of samples well after an expected collection, the sponsor organization is able to focus on their data and the story that it’s telling. This strategy enables sample managers and trial managers to quickly analyze trends, reducing queries and making it easier to identify non-compliant sites for retraining.
Across the board, participants acknowledged that they are focused on setting up sites for success. One attendee shared that her organization’s strategy for minimizing the back-and-forth between sites and other stakeholders throughout the querying process is to consolidate follow-up as much as possible by grouping queries together. Sites have been appreciative of this approach, as it streamlines communication and minimizes the time spent on investigations.
Unfortunately there are still gaps in sample management processes that lead to downstream complications once a sample is collected. For instance, one roundtable participant highlighted the challenges that third-party specialty labs face when they are asked to reconcile samples that they are expected to receive, but are outside of their purview. The European Union’s General Data Protection Regulation (GDPR) only exacerbates this conundrum, as these same labs are also being expected to track consent information.
These challenges are also felt by stakeholders on the CRO side. One attendee from a reputable CRO echoed the frustrations that third-party labs experience, as they too lack full visibility into the sample journey. Without this vital information, CROs are unable to support third-party labs in providing them with transparency around sample statuses. Even when his organization issues queries, this attendee acknowledges that sites are often too busy managing countless patients and studies to give sample reconciliation the time and attention that it deserves.
One participant shared the importance of promptly gathering information from sites and labs about missing samples as soon as a collection is expected or documented. In some of the most complex situations, the sponsor must follow up with couriers and various labs to determine if a sample was mishandled in transit or otherwise shipped to the wrong lab location. These intensive investigations often involve countless emails and back-and-forth phone calls, and in too many cases these desperate efforts yield no results.
When there are gaps in downstream sample data, it is often indicative of a broken process on the front end of sample management. One attendee used the roundtable forum as an opportunity to emphasize the importance of honing in on the root causes of shortfalls in sample data, which may include site staff who do not have sufficient training.
In order to make sense of the widespread challenges with sample reconciliation, it’s also important to scrutinize current practices for managing the reconciliation process as a sponsor. Multiple roundtable participants reported using Excel as their main tool for sample tracking. One attendee explained her organization’s process in detail, which includes manually comparing spreadsheets to manifests, record logs, and their studies’ sample configurations. Another attendee shared that their spreadsheets manually pull data from emails that include shipment tracking numbers for samples; this process requires a lot of effort, as the attendee reports that they receive hundreds of these emails every day.
There were also some interesting approaches for using technology for reconciliation. One roundtable participant discussed her organization’s use of a data lake to track sample information; this data is then compared to central lab and specialty lab data so that they can quickly identify discrepancies due to typos during data entry, bad handwriting on a paper requisition, and more.
As sponsors navigate widespread challenges with sample reconciliation, it is important to reflect on opportunities for improvement and innovation. One attendee discussed always keeping their risk mitigation plan up-to-date with historical examples of process breakdowns, so that study stakeholders can learn from past mistakes. Roundtable participants collectively agreed that this was a practical approach to sample management, but the overarching discussion revealed a significant need in clinical research: granting all trial stakeholders end-to-end visibility into the sample journey. Real-time sample tracking capabilities, audit trails, and unbroken chains of custody have the potential to streamline reconciliation — enabling sites, CROs, sponsors, and labs to improve collaboration with one another, optimize their use of time, and most importantly maximize data integrity across their studies.
This kind of solution is already available to sponsors. With Slope’s sample management platform, sites are empowered to collect samples the right way and send them to the right places at the right times. Throughout sample collection and processing, Slope automatically captures important sample data that is easily accessible to sponsors and other study stakeholders during the life of the study.
To learn more about how Slope is revolutionizing clinical trial execution, click here.