Patient samples have always been critical assets for clinical trial success. In this era of precision medicine, in which researchers seek to tailor treatments on the basis of a specific patient’s biomarker profile or disease characteristics, sample management has become even more important and valuable. It is critical to ensure that clinical samples collected during a trial constitute a robust sample set that can be used for elucidating mechanism of action, stratifying patients, and monitoring response to treatment. Consequently, having a plan to ensure sample quality, minimize processing time post-blood draw, and manage logistics is crucial for optimizing the accuracy and integrity of clinical trial data.
Clinical trial samples span a spectrum of urine, blood, cells, DNA, RNA, and protein and tissue specimens, requiring a broad range of technologies and approaches for analysis. To ensure sample quality and data accuracy, every step of sample management—including collection, labeling, shipment, storage, processing, and testing—must be carefully choreographed.
Key Tenets of Sample Management
While the nuances of sample management will vary on the basis of the specimen type, there are certain strategic principles that apply across the board:
Document proper patient preparation prior to specimen collection
Specify the container and transport medium required for each sample type
Outline the labeling requirements, such as patient identifiers, site, and associated clinical sample collection information
Establish sample processing and testing protocols to ensure consistency across laboratories
Develop a plan for streamlined logistics and secure storage
Selecting the Right Samples
The samples needed to support a study will be determined by the clinical trial objectives and endpoints, along with feasibility of specimen collection. For instance, immune monitoring has become an essential strategy for understanding, predicting, and monitoring the immune system response to therapeutic interventions. Researchers who are seeking to perform immune cell profiling with flow cytometry will need to determine what analytes will be measured and which assay will be performed in order to choose the right sample. If looking for absolute cell counts per milliliter of blood, whole blood is appropriate. If looking for subtle changes in cell populations over time and the markers of interest are stable in cryopreserved cells, banked cryopreserved samples are likely to yield the most robust, accurate data.
Coordinating Sample Processing and Logistics
Biological samples often require specific conditions for collection, handling, and sample processing. For example, factors such as time, nutritional state, anticoagulant type, shipping conditions, and even method of isolation may influence the immunological function of peripheral blood mononuclear cells (PBMCs) isolated from whole blood. Studies have shown that when comparing antigen-specific T-cell responses in different individuals, it is critical to standardize the procedures for blood collection, processing, and preservation.1 Minimizing the time between venipuncture and PBMC isolation helps ensure cell viability and freshness.
A sample management plan must include procedures for the proper collection, preparation, and shipment of samples at the required time points and in the required conditions. For example, if seeking to perform receptor occupancy assays using real-time flow cytometry, whole or stabilized blood will need to be processed by the lab on the day of receipt. Researchers who want to streamline immune monitoring may want to consider epigenetic immune cell quantification using Precision’s patented Epiontis ID technology. A significant advantage of Epiontis ID is that it can be applied to fresh, frozen, or paper-spotted dried blood and other bodily fluids or tissues, eliminating the need for special care during transport and storage and potentially reducing overall cost.
Often, researchers may want to perform batch analyses of stored samples, not just for logistical convenience but also to reduce variability—particularly when samples are collected longitudinally from the same subjects. Understanding proper storage and the impact of the freeze/thaw process on cell viability and function will help shed light on the optimal processing approach.
Leveraging the Expertise of an End-to-End Specialty Lab Service Provider
Trials involving multiple sites and independent testing labs are subject to variability in the quality of processing and, hence, variability in the resulting data. At Precision for Medicine, we have focused on building a network of specialty labs with consistent protocols, with the goal of obtaining the highest-quality samples for the best possible downstream data. We offer a broad range of platform technologies and approaches, including flow cytometry, epigenetic immune cell phenotyping, cytokine analysis, genomic profiling, sequencing, liquid biopsy, immunohistochemistry and multiplex immunofluorescence.
Our end-to-end solution offers real-time processing in more than 55 countries, custom assay and kit development capabilities, and state-of-the-art biobanking facilities for secure storage, management, and distribution of samples for future use. Precision also offers custom specialty lab solutions tailored to specific clinical trial requirements, helping researchers ensure high-quality samples and optimize the value of their study data.
1. Mallone R, Mannering SI, Brooks-Worrell BM, et al. Isolation and preservation of peripheral blood mononuclear cells for analysis of islet antigen-reactive T cell responses: position statement of the T-Cell Workshop Committee of the Immunology of Diabetes Society. Clin Exp Immunol. 2011;163(1):33.49.
Angelina Bisconte is an authority in utilizing human primary biological tissue and cells in research and drug discovery. She is a developer of translational biomarkers for Phase I/II clinical programs in autoimmunity, inflammation and cancer, and is an expert in phenotypic cell-based assays using multiple primary cell systems such as T/Th17/T-regs, NK-T, B/Plasma/Plasmablasts, Myeloid cells, Dendritic cells (pDCc/mDCs), and MDSCs. She serves as a strategist in multi-parametric single-cell flow cytometry and analysis of flow cytometry data. Additionally, Angelina maintains a broad network of contacts at clinical sites and research hospitals, experienced with IRB submissions and clinical protocols. She is a scientific leader for Precision’s Biomaterials commercial sourcing.
Precision for Medicine is part of the Precision Medicine Group, an integrated team of experts that extends Precision for Medicine’s therapeutic development capabilities beyond approval and into launch strategies, marketing communication, and payer insights. As one company, the Precision Medicine Group helps pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.