Clinical Trial Monitoring for Tissue Samples: Is Your Sample Management Strategy Sufficient?
If you’ve ever worked on a trial involving tissue samples, you know that these precious biospecimens are unmatched in their level of importance to clinical research, as well as in the level of complexity required to manage them.
But why is this the case? Unlike other sample types (such as blood or urine), patient tissue is often irreplaceable — not only because the specific tissue types that are studied may be in limited supply in the human body, but because these samples are also often obtained through invasive procedures.
Additionally, once collected, patient tissue may follow one of several workflows, depending on the type of tissue that the research site is submitting. For instance, consider the fact that many oncology trials allow for multiple tissue types to be submitted for testing — including fresh biopsies, tissue blocks, or slides. Not only do each of these samples change hands several times across several stakeholders as they undergo numerous processing steps before they are tested at a pathology lab, but each sample may also follow a unique journey depending on the type of tissue being submitted. As you can imagine (and have likely experienced), tissue samples come with so many nuances that make sample tracking a headache, therefore putting tissue samples at greater risk of accidental mishandling.
Because patient safety and data integrity are paramount to clinical operations, the stakes for managing tissue samples are exceptionally high. Mishandling or loss of these samples not only jeopardizes the integrity of trial data, but also harms the patient experience. Sponsors should prioritize the implementation of a comprehensive sample management strategy that mitigates risks and enables real-time tracking capabilities. This in turn can support a robust monitoring strategy that shields tissue samples from mishandling, therefore upholding the highest standards of quality and compliance.
So what does the scientific significance of patient tissue samples tell us about its importance to our sample management and monitoring strategies? What factors should sponsors consider as they weigh their options for improving their management of patient tissue samples?
The vital role of tissue samples in clinical trials
Tissue samples play a pivotal role in advancing precision medicine and companion diagnostics, where treatment decisions are guided by patients' genetic profiles and biomarker expression patterns. They serve as invaluable resources for elucidating disease mechanisms, identifying therapeutic targets, and evaluating treatment responses. By correlating molecular signatures with treatment responses, researchers can identify patient subpopulations most likely to benefit from specific therapies, thus optimizing clinical trial design and improving patient outcomes. For instance, in rare disease trials, tissue specimens enable researchers to uncover underlying genetic abnormalities and develop targeted therapies.
Given the indispensable nature of tissue samples in driving scientific discovery and therapeutic innovation, it is imperative that sponsors prioritize their effective management and tracking throughout the clinical trial process. A robust sample management solution should streamline workflows, minimize errors, and ensure the integrity of trial data, ultimately accelerating the pace of medical progress and bringing life-saving treatments to patients in need. But what are the challenges that are inherent to tissue samples that can hinder the effectiveness of traditional approaches?
The challenges of lab sample tracking for tissue samples
Managing tissue samples presents myriad logistical and operational challenges, owing to the complexity of sample processing workflows and the involvement of multiple stakeholders. From collection to analysis, tissue specimens may undergo a series of intricate processing steps — including fixation, embedding, sectioning, and staining — each requiring meticulous attention to detail and adherence to standardized protocols.
Moreover, tissue samples often traverse multiple laboratories and research facilities throughout their lifecycle, further complicating the tracking and monitoring process. Ensuring the seamless coordination of sample handling and processing activities across disparate sites and labs is essential to prevent delays, errors, and discrepancies that could compromise data integrity and jeopardize patient safety.
To address these challenges effectively, sponsors must leverage advanced sample management technologies that offer real-time visibility into the biospecimen lifecycle, enabling stakeholders to track samples' whereabouts, monitor processing status, and capture relevant metadata seamlessly. By centralizing sample data and streamlining data flow between laboratories and clinical sites, sponsors can enhance operational efficiency, mitigate risks, and ensure compliance with regulatory requirements.
The imperative of accurate sample metadata
In addition to logistical challenges, ensuring the completeness and accuracy of sample metadata poses a significant hurdle in tissue sample management. Critical information — such as sample type, collection date, patient demographics, and processing history — must be documented accurately and consistently to facilitate downstream analysis.
Unfortunately, compliance issues with filling out paper-based requisitions often plague clinical trials involving tissue samples, leading to incomplete or inaccurate sample metadata that can impede data analysis and compromise lab results. Addressing these challenges requires sponsors to implement robust data management strategies and enforce stringent data capture standards across all stages of the sample lifecycle.
Moreover, sponsors must provide comprehensive training and support to research site staff to facilitate the seamless, accurate, and timely capture of sample metadata for tissue samples. By investing in education, training, and technology solutions, sponsors can empower clinical sites to capture and transmit sample data quickly and accurately, thereby enhancing data integrity and accelerating the pace of a clinical trial.
It’s time to revamp the way you monitor and manage your tissue samples
Slope is your one-stop shop for managing and tracking all of your samples — including your most complex tissue samples. Thanks to our software-guided sample workflows in our Biospecimen360™ platform, we walk sites through the unique nuances of processing, storing, and shipping every sample type, while automatically capturing the critical metadata you and your labs need in order to facilitate sample processing and testing. Biospecimen360™ not only significantly reduces errors associated with filling out requisition forms — it also unlocks 17x quicker access to sample metadata compared to the EDC.
Biospecimen360™ also enables integrations with LIMS and other clinical systems so that study teams have comprehensive, real-time visibility to the entire biospecimen lifecycle for every patient sample that is submitted for your trial. The result is unparalleled sample tracking capabilities and optimized, efficient clinical operations.
To learn more about addressing the challenges with managing tissue samples, specifically on oncology trials, check out our white paper on Ensuring Patient Centricity in Oncology Trial Sample Management.
Interested in learning more about the other ways in which today’s clinical trial landscape is hindering sponsor monitoring strategies and study compliance? Click here to explore the innovative strategies that sponsors can implement to strengthen their clinical trial monitoring plans, thereby preventing and mitigating common compliance issues.
