August 29, 2023

Utilizing a Central Lab vs. Shipping Directly to Speciality Labs: Important Considerations for Your Next Trial

In the world of clinical trials, meticulous planning is critical to optimizing the success and reliability of study outcomes. One of the key decisions that trial sponsors must make is when to have clinical research sites send samples to a central lab versus when to have them ship samples directly to specialty labs. This choice has major implications for the efficiency, integrity, and cost-effectiveness of the study. In this blog, we will delve into the important considerations that sponsors should keep in mind when designing a study and deciding on sample shipping logistics.

Central Labs: A One-Stop Shop for Patient Samples

Choosing a central lab for sample analysis and specimen management offers several advantages. Sites are able to consolidate most or all of their sample shipments to one destination, thereby reducing the risk of sample mishandling. This setup can be especially beneficial for studies that have less experienced sites who may struggle to juggle shipments to multiple different labs for the same patient visit. Even study coordinators at some of the world’s leading academic medical centers are more prone to making mistakes when they are managing complex sample shipping schemes across several patient visits and trials. 

Partnering with a central lab can also have its financial benefits. When sites are preparing sample shipments for one patient visit, shipping several samples to the same location is far less expensive than shipping the same samples to various locations. When these cost savings are multiplied across every single patient visit over the life of the trial, especially on studies with a large volume of samples, the budgetary impact is immense. Even if some of those samples will ultimately be tested at a different lab, central labs are able to consolidate outbound shipments to specialty labs, significantly reducing the overall transportation costs for a study. 

Oftentimes, central labs offer a broad scope of services and well-established quality control measures, leading to consistent and standardized results. For larger, late-phase studies, central labs can provide cost benefits due to economies of scale, as the volume of samples processed is higher. If a study requires common, non-specialty assays, then it may make sense to leverage a central lab as a hub for sample shipments. 

Considerations for Shipping to Central Labs

  1. Sample Stability: Some samples are more time-sensitive and sensitive to transportation conditions than others. Delicate biomolecules and cells may degrade if not handled correctly during shipping or if not processed within a certain amount of time. If certain samples must be tested at a specialty lab, sponsors should assess whether the central lab’s location and specialty lab locations — along with having samples change multiple hands — could lead to prolonged transportation times that could compromise sample integrity.
  2. Data Turnaround Times: Despite the fact that central labs can aggregate sample shipments and data, shipping samples to a central location may lead to longer turnaround times for analysis at third-party labs. Sponsors must evaluate whether the potential benefits of centralized processing outweigh the impact of extended timelines on study milestones and the resulting of key data points — including safety testing, inclusion/exclusion criteria, dose escalation, and primary/secondary endpoints.
  3. Sample Volume: While the central lab approach offers convenience, it is not a one-size-fits-all solution. Early-phase studies with fewer patients and/or sites are more manageable, and therefore may not require the broader scope of services that a central lab can provide. 
  4. Data Management: Many central lab vendors will offer to manage data from third-party specialty labs, but this additional stakeholder requires data transfers from central lab to sponsor, in addition to the data transfers from specialty labs to the central lab. Centralized data management can also require a significant amount of oversight, depending on the central lab’s level of expertise and the extent of their relationships with the specialty labs that a sponsor is leveraging for a study.

Specialty Labs: Unsurpassed in Expertise

Specialty labs, on the other hand, are highly specialized facilities with expertise in specific types of sample analysis, such as molecular diagnostics, genomics, or rare disease testing. Partnering with these organizations can be particularly advantageous when the study requires specialized techniques or when samples are limited and need to be processed immediately. If the study heavily relies on specialized tests or assays, sending samples directly to these labs can yield insightful results more quickly. These labs are also oftentimes engaged on pre-clinical trials for the same study drug, so their prior experience supporting a program from its inception will prove beneficial during the clinical phases.

Sending samples directly to specialty labs can offer unique advantages in certain study designs. When a sample has fewer stakeholders involved in its chain of custody, reconciliation is easier. Fewer stops also translates to a lower risk for error; the fewer times a sample changes hands, the less likely it is to be mishandled in transit to its final disposition. Direct shipments can also save the sponsor money on storage-related expenses at the central lab. On studies that have a lower sample volume, sponsors should consider whether storage costs, coupled with the costs of inbound and outbound sample shipments from the central lab, will outweigh the cost of direct shipments to the lab.

Considerations for Shipping Directly to Specialty Labs

  1. Collaboration Challenges: Coordinating with multiple specialty labs requires efficient communication and synchronization. Sponsors must establish clear lines of communication with all of the labs that they’re partnering with, but nurturing these relationships often requires a great amount of effort.
  2. Disjointed Data Sources: When several labs are involved in a single study, more work must be done to aggregate and manage data. Many central labs offer data management services that streamline this process for sponsors, especially if a central lab is already acting as an intermediary for the inbound and outbound shipments of samples. Regardless, managing several data sources across multiple labs can be time-intensive and costly. 
  3. Sample Volume: For studies with a high volume of samples, specialty labs may be less equipped to handle lab queries, data reconciliation, and batch testing of a large number of samples.

Choosing the Right Approach: Factors to Consider

  1. Study Goals and Complexity: The nature of the study plays a significant role in the decision-making process. If the trial involves a wide array of sample types and analyses, a central lab might be more efficient. Conversely, studies with highly specific analyses may benefit from direct collaboration with specialty labs.
  2. Sample Volume: If the study involves a large number of samples, central labs might be more cost-effective. For smaller studies or studies with rare samples, shipping directly to specialty labs could make more sense.
  3. The Types of Samples Being Tested: Certain samples need to be tested more urgently than others — either because the sample will degrade shortly after collection, or because the sample is pertinent to important study outcomes. If a specialty lab is testing any of these highly sensitive samples, then a direct shipment to a specialty lab may be necessary. On the other hand, for samples that do not need to be processed as urgently, a central lab may be optimal. 

Final Thoughts

In the realm of clinical trials, the decision between central lab and specialty lab sample shipping is not a one-size-fits-all choice. Clinical trial sponsors must carefully evaluate the unique aspects of their study, including the kind of testing being performed, study goals, logistical considerations, and cost implications. Both approaches have their merits and challenges, and the ultimate decision should be guided by the aim of ensuring accurate, complete, and timely results. By thoroughly analyzing these considerations, sponsors can make an informed choice that aligns with the study’s objectives and maximizes chances of success.

It’s important to note that many central labs and specialty labs struggle to provide end-to-end visibility to samples. Even if a central lab is engaged in a study, they oftentimes aren’t equipped to provide sponsors with real-time visibility to the status of a sample that isn’t in their possession. Even the most optimal study designs come with limitations beyond specimen tracking — from data lags to disjointed data sources — but it doesn’t have to be that way. 

Slope’s platform uses software-guided workflows to transform site operations by walking site staff through sample collection, processing, and shipping. The entire sample journey — from kitting to its final disposition at a biorepository — is visible to sponsors in real-time, enabling them to maximize oversight of all clinical trial activities. Slope also transforms study execution by connecting systems and study stakeholders to direct site operations, driving real-time, traceable, and operational clinical data.

To learn more about how Slope can transform your study operations, click here.

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