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.
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.
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.
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.