When outdated kits led a site astray, real-time monitoring caught a critical omission before it impacted the study.
However, discrepancies can exist between the kits-in-hand and the current version of the protocol, resulting in deviations. One typical example in oncology studies might be the addition of cytokine samples to the initial assessment. Across the industry, as the number of protocol amendments rise, the propensity for deviations also increases. TruTechnologies provides a mobile digital guide and real-time deviation detection to ensure protocol-compliant handling of every sample.
Clinical trials often collect cytokine samples to provide insights into the treatment’s safety, effectiveness, and mechanisms. Cytokine release syndrome (CRS), a common side effect of some immunotherapies, can be detected through these samples. In addition, they can measure how well a patient responds to the treatment.
By identifying specific cytokine markers, researchers can predict which patients might benefit from the treatment and who might be at higher risk of side effects. This analysis can help optimize treatment protocols in the future by informing dosing and timing decisions based on an individual's cytokine profile.
To support cytokine sample collection, central labs assemble visit-specific kits with the necessary tubes and materials based on protocol requirements. While these kits are designed to simplify workflows, site staff often rely on them as a step-by-step guide rather than consulting the full protocol.
This becomes problematic when protocol amendments introduce changes — such as adding cytokine collections at new time points — but kits are not updated accordingly. Delayed kit updates, quality control oversights, or staff inadvertently using an outdated kit can lead to missed samples, jeopardizing data integrity and compliance.
One sponsor used TruTechnologies for a Phase 1/2 oncology study in March 2023. The initial protocol did not include a collection for a cytokine assessment. Later in the study, however, the sponsor amended this already complex protocol to include the cytokine sample, critical to assessing baseline conditions and early treatment response.
However, the site’s kits were never updated with the additional tubes, creating a small but significant discrepancy. Unaware of the change, clinical staff relied on the kit-in-hand rather than the updated protocol to guide the next patient visit.
Fortunately, TruTechnologies' real-time monitoring detected the omission while the patient was still onsite and immediately alerted the site. Staff confirmed they had used an outdated kit, and with TruTechnologies’ guidance, they were able to collect the sample before the patient left — preventing an important protocol deviation.
Without TruTechnologies, the missing cytokine collections might have gone unnoticed for weeks, leading to continued errors across multiple sites. Instead, timely detection preserved critical data and prevented further deviations.
• Early detection of missing cytokines prevented future deviations
• Protection of data integrity that could have been compromised
• Identification of outdated kits on-site
• Trust in TruTechnologies' mobile app as a protocol guide instead of the kits
As protocols grow more complex and amendments become more frequent, even small discrepancies can lead to widespread protocol deviations. Since sites naturally rely on kits to guide sample collection, outdated kits pose a persistent risk. Without early detection and intervention, minor deviations can compound into larger compliance issues across multiple sites and regions.
TruTechnologies addresses this challenge by providing a mobile digital guide that ensures site staff follow the most up-to-date protocol, rather than relying on kits. Combined with real-time monitoring and early deviation detection, TruTechnologies helps safeguard data integrity and ensure samples are handled correctly from collection to final destination.
