Biological samples and the data they produce are more crucial than ever to the safety and efficacy of a clinical trial, as well as proving compliance with regulatory responsibilities. However, ensuring the data integrity for all the samples — traveling from sites to central labs, to specialty labs, to biobanks — is traditionally a fragmented, labor-intensive, and siloed process. Failure to ensure samples are managed according to the study documents, which include all applicable amendments, and adhere to regulatory oversight obligations, can have a devastating impact on clinical trials.
Poor sample management can lead to inaccurate data, increased costs, regulatory risk, and potentially dangerous consequences for patients.
One of the most significant consequences of poor sample management is missing, inaccurate or unreliable data. When samples are mishandled, the results of tests conducted on these samples may be compromised, leading to misleading or false conclusions. Since sample data is used to inform all safety and efficacy treatment decisions, accurate and complete data is crucial. In the worst-case scenario, drugs may be approved for use based on faulty data, putting patients' health and safety at risk.
Another impact of poor sample management is increased costs. If samples are mishandled, lost, collected out of the visit window, or incorrectly labeled, it may be necessary to repeat tests or replace patients. This can increase the workload, costs, and timelines associated with the trial — especially for oncology, rare disease, and personalized medicine trials, where each sample is critical and very expensive.
Study delays can also be caused by reactive risk mitigation. When sponsors lack full oversight of the sample journey, issues are not uncovered until well after they have occurred. In those instances, the study teams may need to scramble to keep their study on track while retroactively trying to determine the cause of the problems. Investigating these issues results in delays, as pinpointing the root cause requires costly and arduous backtracking.
Many times, complete sample results are required to progress to the next phase of a clinical trial. Delays in those results also have a direct impact on the ability for the sponsor to gain enough funding to keep the program running.
According to our recent conversation with Edye Edens — a licensed attorney with an international human rights, ethics, and health law background — sponsors, CROs, and sites are already contractually obligated to follow GCP standards around sample chain of custody. Failure to ensure a complete and accurate chain of custody is, in essence, a breach of contract. Sponsors should be able to prove a fully traceable chain of custody and sample compliance down to the individual sample.
Patients are often willing to travel long distances for their visits to endure rigorous sample collection procedures. If samples are lost, mishandled, or are deemed inaccurate, it means patients have to repeat the visit and sample collection process, or perhaps even be disqualified from a study. An example is when the lab value that was needed to enroll the patient is missing. Or worse, the patient was enrolled and later found out that they weren’t eligible.
Poor sample management can also increase regulatory risk if a patient’s negative experience drives them to withdraw their consent to use their sample. If the sponsor cannot identify and destroy the patient's sample, they may find themselves in the position of not being able to fulfill the patient’s wishes and they may also face regulatory consequences.
According to a recent industry survey, 62% of biopharma executives stated they do not have real-time visibility into lab samples, and a staggering 95% have experienced an increased trial budget, timeline delay, or data quality concern as a direct result of lab kit supply, drug supply, or sample issues. At the same time, 91% of biopharma executives reported that a fully traceable chain of custody is moderately important to very important in demonstrating a clinical trial’s data integrity.
The process by which sponsors oversee the entire sample journey and maintain a fully traceable chain of custody needs to evolve. Traditionally, sample management is a disjointed, siloed process with existing gaps in visibility and data. With Slope, sponsors and sites no longer have to piece together a sample’s journey by comparing EDC records against site patient records and making assumptions in the middle. The Slope platform provides a 100% traceable chain of custody across all stakeholders in a clinical trial, all in one easy-to-use platform.
To learn more, check out Slope sample management