These biospecimens provide the data that sponsors need in order to determine the safety and efficacy of potentially life-saving, life-changing treatments. Just as important, however, the patient samples that support clinical research are physical extensions of real people who oftentimes already find themselves in a vulnerable state because of disease. Treating their biospecimens with extreme care not only optimizes and accelerates study outcomes; it’s also an act of respect towards those who are already sacrificing so much of themselves by participating in a trial.
Regardless of whether you work for a sponsor who supports clinical operations, biospecimen operations, translational medicine, or something in between, you likely play a role in ensuring that these samples and their data are treated with the utmost integrity. Unfortunately, the reality is that the nature of clinical research complicates our best efforts to successfully execute on our promises and obligations to patients.
Let’s consider the sheer number of samples that sites, labs, CROs, and sponsors are responsible for managing at any given time. This is a direct result of the complexity of today’s clinical trial designs, which necessitate multiple sample collections and timepoints to support primary and secondary endpoints for a study protocol. Sites and labs that support several trials and sponsors may be fielding as many as hundreds or thousands of samples at any given time. Even in your role as a sponsor, you may be responsible for oversight of a large quantity of samples globally — either on a single trial, a few trials, or an entire portfolio of trials. Given the sheer number of sample collections that are needed to support primary and secondary endpoints, as well as the inevitability of human error, biospecimens are bound to slip through the cracks without the proper processes and workflows in place.
What’s more, samples often have to go through several steps before and after they are tested. The biospecimen lifecycle embodies the total trajectory of a sample from its nascent state as an empty collection container in a lab kit, to its final state as a tested or stored sample. Not only do sites have to perform unique processing, storage, and shipping procedures for every sample, but those samples may be processed even further by downstream labs. Unfortunately, additional risks emerge each time a sample moves to another phase of its lifecycle. This is especially true when a sample changes hands from one staff member or one study stakeholder to another.
As a sample works its way through its predestined steps, it’s not only subject to countless hazards, but the data associated with this sample makes its way through various documents and clinical systems — from site spreadsheets, EMR systems, and paper requisition forms, to EDC, lab databases, CROs, and eventually sponsors. Because these systems are often disjointed, they necessitate manual, repetitive data entry that fragments the sample journey across multiple data sources.
Given the high stakes that come with being a steward of patient samples; the complex journey of these samples; and the disconnected nature of the data associated with these samples, sponsors must invest in a comprehensive strategy for monitoring biospecimens. Sample tracking is the process of overseeing the movement of patient samples and the data associated with these samples, ensuring that they are being handled consistently, accurately, and in a timely manner. Ideally, a robust sample tracking strategy should also enable trend analysis and quick identification of sample-specific issues. With these capabilities, study stakeholders can promptly and accurately pinpoint the root cause of issues and mitigate problems that could jeopardize study milestones, study outcomes, and a patient’s experience on a trial.
In today’s landscape, what does sample tracking look like in practice? Unfortunately, given the complexity of the sample journey and the disconnected nature of sample metadata, sample tracking tends to be a highly manual process that requires a significant amount of time and resources. Sponsors and CROs may spend hours of their time each week pulling reports and data from multiple systems and portals in an effort to piece together the sample journey.
Time and effort commitments aside, these makeshift solutions are far from perfect. Because it takes time for data to move from one stakeholder or system to another, data lag makes it nearly impossible for sponsors to have real-time access to the data they need to identify issues and make critical decisions about their studies. This means that sponsors are hindered and delayed in their ability to take action based on sample-specific, patient-specific, visit-specific, site-specific, or study-wide data. Additionally, sponsors may lack visibility to certain aspects of the sample journey altogether, which can lead to a significant amount of back-and-forth between sponsors and other study stakeholders to fill in the blanks.
To make matters more difficult, data that is scattered across multiple sources must inevitably be reconciled. Discrepancies and missing data can hamper the effectiveness of sample tracking even further, making it feel like a necessary exercise with little real-world benefit.
Given the critical importance and dignity of patient samples, there should be an industry standard solution for sample tracking that addresses the aforementioned problems. So what can sponsors do to improve the efficiency and precision of their sample tracking efforts? In order to answer this question, sponsors should scrutinize every stage in the biospecimen lifecycle. What gaps currently exist at each stage? And what specific data do sponsors need access to at each stage in order to get a comprehensive picture of their samples?
Sample tracking can’t happen without optimal lab kit management
Common sense tells us that you can’t build a house without a foundation — so how can you perform proper sample tracking without the clinical inventory needed to collect the samples that are being tracked?
Lab kits act as the building blocks for sample metadata. In most cases, lab kits contain the requisition forms that sites use to record and disseminate critical sample metadata — like collection dates and times, patient demographics, sample and visit identifiers, and more. The labs then digest this information within their own databases — a process that is critical to sample tracking. Additionally, lab kits often have their own unique identifiers — often referred to as accession numbers — that are then inextricably linked to the samples within a given lab kit. That unique identifier is with the sample at the start of its journey, following it as it goes through processing, testing, and storage at a downstream lab or facility.
Unfortunately, most sponsors don’t have accurate visibility into their lab kit data. For instance, many lab kit vendors do not track expiration dates on behalf of sites. If sites forget to report their expired or discarded kits, the lab kit numbers that sites and kitting vendors see may not be accurate. This not only distorts a sponsor’s view of the inventory they believe to be in stock at their sites, but it also can render automatic resupply schemes ineffective.
Sites also may not be equipped with the right tools to manage their inventory. Often inundated with an excessive number of lab kits, sites often lose the lab kits they actually need. Research coordinators may rely on outdated or insufficient methods for keeping tabs on their inventory — including sticky notes, spreadsheets, and a lack of standardized processes across their entire research organization. As a result, sites are more susceptible to losing the lab kits they actually need, not being able to keep track of expiration dates so they know when to order more supplies, and more.
Optimizing lab kit management improves the success of whatever sample tracking solution you choose to adopt on your study. The more compliant your study is with lab kit management, the more likely all of your expected samples — and the metadata associated with those samples — will be collected accurately, completely, and in a timely manner. After all, how can you track a sample that wasn’t collected due to insufficient inventory? How can you track a sample that was manually pieced together using supplies that the site had on hand, but isn’t actually tied to a lab kit that was assembled for your study?
Ultimately, sponsors should monitor on-hand inventory at each site and expiration dates to ensure that their studies have a sufficient amount of lab kits for upcoming patient visits. This data should include visibility to which kits were built under which amendment versions, so that when a protocol amendment or lab manual modification impacts a lab kit, the impacted lab kits can be easily identified. These solutions will set up sponsors for further success with sample tracking, and perhaps even save them thousands or millions of dollars on lab kit waste over the life of a study.
Sponsors need better visibility to sample management activities at the site so they can pinpoint the root cause of compliance issues
Assuming sponsors have a robust inventory management system in place for their study, they are able to properly begin to track their samples. Sample tracking should ideally start at the very beginning, from the moment the sample is collected at the site. Sponsors need to understand the various activities that are occurring at a site when it comes to the handling of patient samples and sample metadata — especially because in today’s clinical trial landscape, these processes and data points can be multifaceted and complex.
Unfortunately, most sponsors do not have visibility to their samples until they have arrived at a lab. Anything that happens before that is completely unknown to them, so investigating missing, mishandled, or delayed samples is a difficult challenge. Without this visibility, sponsors aren’t able to pinpoint where non-compliance issues are happening. Is it happening during collection, processing, storage, or shipment? Are there any compliance trends at a certain site? For a certain sample type? For a certain visit? With easy access to these insights, how much time can sponsors and sites save on sample-related queries and investigations? What kinds of corrective actions can sponsors implement to prevent or minimize these compliance issues just by having access to more precise data around sample management activities? Can sponsors leverage their sample tracking solution to not only increase their own visibility to patient samples before they even ship from a site, but to also improve site compliance with sample management procedures?
Sponsors should consider sample tracking solutions that capture site activity for every step of sample management — from collection to shipment. This data can show what actions have been performed, at what times, and who performed each action, empowering sponsors to drill down to sample-specific inquiries or surface pertinent data trends.
Biospecimen data capture at the site during a patient visit gives sponsors and labs visibility to samples before lab receipt
In addition to physically collecting samples, sites are also responsible for capturing sample metadata that carries with the sample on the remainder of its journey; this includes patient demographics, visit and sample identifiers, collection dates and times, and pertinent pre-analytical variables that labs need for further testing and/or processing. In most cases, this is data that lives on the requisition form.
Sponsors need this data to be complete and accurate the first time around — not only because this data offers sponsors important contextual information about the samples that are being collected on their trials, but because labs require this data in order to process, test, and/or ship samples. If critical sample metadata is missing or incorrect on the requisition form, then sites run the risk of lab queries, which have the potential to stall lab results, sample shipments to third-party labs, or sample testing/processing.
Sponsors need a sample tracking solution that surfaces sample metadata as soon as it’s captured at the site, before it’s entered into the EDC or a lab database. This enables sponsors to quickly identify missing data or discrepancies, while equipping sponsors with pertinent information that can be used to identify study trends and make study decisions.
Streamlined sponsor access to sample shipment information from site to lab offers peace of mind
Visibility to patient samples prior to shipment at the site is critical, but sponsors need to know if and when samples are on the move. Unfortunately, as it currently stands, many sponsors do not have real-time visibility to samples that are in transit. Oftentimes they have to manually request tracking numbers from their sites, and these tracking numbers must be manually reviewed on a courier website to determine where the sample is in its physical journey from site to destination lab. Considering all of the other responsibilities that sponsors already have on their plate, along with the sheer volume of samples that are being collected on a daily or weekly basis on a single study, checking sample tracking numbers to ensure that the sample’s journey is going smoothly is simply not feasible.
It’s important for sponsors to not only have automatic access to shipment tracking numbers as soon as they are available, but to also have the data that is captured on those tracking numbers automatically surfaced to them so they can easily detect any anomalies in the sample journey. For example, sponsors should be made immediately aware of any samples that have been shipped according to the site, but have not yet arrived at the destination lab; or samples that are taking longer than expected to arrive at the lab.
Improved access to lab receipt and lab processing details offers a new level of transparency to sponsors
After your samples arrive at the lab, it can feel like they have gone into a black hole. Once the courier delivers your samples, the samples must be accessioned (i.e. acknowledged and received) into the lab’s database in order to initiate sample processing and testing. Even though sample receipt at a lab can be monitored through tracking numbers and sample reports that are generated by the lab, this data can take days to access — even then, sponsors lack complete visibility to processing that may occur at a lab, including aliquoting, slide sectioning, and more. Lab queries can complicate this process even further, as sample information may not be readily available in a lab database until a query is resolved.
Additionally, sample testing may be canceled at the lab for any number of reasons — including stability issues, sample hemolysis, site or lab errors, and more — but sponsors often have to run separate reports in order to access cancellation data. This process adds an additional step to an already highly manual, cumbersome sample tracking process.
Sponsors should have more complete, quicker visibility to sample management activities occurring at the lab, from sample receipt to sample processing to sample testing and storage. This is a critical part of the sample journey that currently is either inaccessible to sponsors entirely or currently manually tracked across multiple reports.
Awareness of shipments between labs and biorepositories fill a critical gap in the biospecimen lifecycle
These days, it’s not uncommon for samples to have to travel from one lab to another lab or biorepository. Unfortunately, despite the fact that these shipments are just as critical as — if not more critical than — shipments from sites to the central lab, sponsors are almost always in the dark when it comes to tracking these shipments. Just as is the case with sample shipments from the site, sponsors often need to manually request visibility to lab to lab sample shipments — and sometimes may not even receive the tracking information until after the shipment has arrived at the secondary facility.
When sponsors don’t have visibility to these samples during this leg of the journey, how are they supposed to ensure that the samples actually arrived at a third party lab for testing within the expected timeframe, or otherwise arrived at a biorepository for safe keeping? Sponsors should be made immediately aware of any samples that have been shipped according to the lab, but have not yet arrived at the final destination lab or biorepository; or samples that have run into issues in transit.
What can sponsors do with their sample tracking data?
At this point we’ve established that it’s important for sponsors to have full visibility to their sample metadata — from the pre-analytical and analytical variables that tell the full story of their samples, to the information about the physical movement of your samples from sites to various labs and biorepositories. But why?
Sample metadata does much more than fulfill regulatory requirements and enable critical functions like risk-based and centralized monitoring; it’s also critical to the everyday decisions that sponsors make — from those in clinical and biospecimen operations, to those in translational medicine.
Real-time, accurate sample metadata can empower sponsors to do the following:
- Determine lab strategy
- Inform dose escalation
- Prepare for database lock
- Address high-risk samples/sites to meet protocol endpoints
- Test scientific hypotheses
- Optimize inventory and perform demand forecasting
- And more!
Ultimately, real-time access to clean sample metadata can lead to better, accelerated study outcomes. When sponsors are able to instantaneously access all of the information about their samples, it enables decision-making that improves the likelihood of a promising therapy making it to market, maximizes efficiency, improves collaboration, and safeguards the patient experience on a trial.
