We all recognize that proper sample management is essential. Patients should not be subjected to additional collection procedures because samples were incorrectly collected or lost. Trials should not be delayed or jeopardized due to poor sample traceability, lack of sample data integrity, or risk mitigation.
However, since sample management is spread across many contributors — such as sites, couriers, labs, CROs, sample management vendors, and sponsors — clinical trials without a robust process are susceptible/vulnerable to numerous risks. On top of that, there is a different definition of sample management across different organizations, leading to even more confusion on what approach to take. As a sponsor, it is essential to ask the right questions about sample management to mitigate those risks.
What are the top questions you should ask about sample management?
The key to this question is to understand how sites are informed of their required activities related to sampling. Additionally, this understanding should include whether there are any proactive measures in place to mitigate obstacles in real-time, rather than simply reacting as issues arise. Many times, sample management is overlooked until there is a problem, resulting in lost or mishandled samples that could have been avoided — or worse, impacts to the study timelines, budget, and patients.
The first step is to determine how sites are enabled and set up to conduct sampling for the study. Sites are typically inundated with training to meet the requirements outlined in their study documents, however this can be alleviated by leveraging a system that enables site sampling workflows from collection, processing, and shipping. This system would guide sites to follow the protocol and lab manuals without the need to constantly reference and decipher instructions, especially in scenarios where studies are changing.
Sponsor oversight in clinical trials is key to trial data integrity, reliability of study results, and trial conduct in accordance with good clinical practice (GCP) and regulatory expectations. Even though sponsors are not the ones executing the clinical trial, they are ultimately responsible. Therefore, oversight is critical.
As such, sponsors should delve deeper into exactly what it means to have oversight and management of samples from the site to the lab, or from one lab to another.
Is it manual oversight or systematic oversight? Are there gaps in visibility between sites and labs, or between multiple labs? What mechanisms are in place to track down a specific sample if consent was withdrawn?
Manual oversight typically involves spreadsheets (sometimes tracking thousands of samples), which are prone to error. Even worse, sometimes there is no tracking at all. Manual processes also require vastly more time and resources, leading to inefficiencies and increased cost.
On the other hand, systems that leverage study-configured workflows and mobile barcode scanners to reduce manual errors at the site level — and enable full visibility from site to lab, and lab to lab, regardless of couriers — provide real-time visibility to sponsors through an optimized and convenient study dashboard. This way, sponsors have full oversight of every touchpoint throughout the sample journey and can track down any sample, at any time.
Queries are a top pain point for sponsors and sites. They are time-consuming to resolve and critical to data reconciliation at all points in the study, but especially in study closeout. As such, sponsors should ask detailed questions about query resolution, including the expected burden on site staff. Every organization should lead with a site- and patient-first mindset, essentially ensuring that whatever can be done to alleviate effort in favor of standardization should be done. This means it’s important to discuss the processes in place to identify, triage, and resolve queries in a timely manner. If possible, query resolution metrics should be provided. Best-in-class solutions should eliminate the bulk of queries, and necessary queries should be resolvable in minutes, not hours or days.
In a previous blog, we highlighted the inconsistencies between what is considered sample management, depending on which stakeholder you are talking to: Sites, labs, CROs, or sponsors.
Clinical research sites have sample visibility from patient collection through shipping to the lab. Labs have visibility from sample receipt through processing. Sponsors and CROs have visibility from receipt at the lab to resulting (through email or LIMS).
As you can see, one stakeholder’s output is another stakeholder’s input. Therefore, it is important to ask the question, “When you say you have a ‘full sample chain of custody’, when does it begin and end?”
Likely, because clinical trial stakeholders are siloed, and systems are disparate, a given sample’s “full history” will only really be a portion of the entire sample journey. As it relates to the sponsor oversight requirements above, is that “full history” enough? Fortunately, there now exist systems that offer 100% traceable chain of custody from collection at the site, all the way to receiving results at the sponsor — no matter how many labs were included in the chain.
Clinical inventory such as laboratory kits have typically been seen as a means to an end in clinical trials. Sponsors certainly understand that samples cannot be safely and reliably obtained, stored, and shipped without the availability of proper collection vessels, however clinical inventory is often an afterthought in sample management planning.
Each lab kit should result in an individual patient sample that can be followed step by step through a sample journey, but lab kit management is not something sponsors are usually focused on. There are many times where kits are either not available, are expired, or unusable, which prevents the site from collecting a sample and completing a patient visit. If clinical inventory is not understood, the sponsor will not have the ability to demonstrate that essential sample chain of custody mentioned above. In addition, operating in a reactive fashion means there will be no way to ensure that sites have what they need to conduct those critical visits.
Clinical inventory needs to be managed by a system that has the ability to proactively use study data to resupply research sites, and to provide insight into the sample chain of custody.
Questions like these are good conversation starters to ensure your sample management process is best-in-class. Interested to learn more about Slope’s sample management capabilities? Visit slopeclinical.com/sample-management or contact us today.