Integrating Self-Collection Lab Panels: The Clinical Lab Perspective
Successfully designing a trial using self-collected samples requires early engagement with the clinical lab team
Chuck Drucker, MBA, is the vice president of strategy and corporate development for Q2 Solutions, the laboratory division of IQVIA, where he is accountable for developing and driving the company’s inorganic and organic growth strategies. He also leads decentralized trial solutions and previously led alliance management and marketing at Q2 Solutions. In addition, he is the founder of Sales and Marketing Professionals in Science (SAMPS). Prior to Q2 Solutions, Drucker held positions at Quest Diagnostics, Covance, AAI Pharma, and Amersham Biosciences (now Cytiva). He has an MBA and a bachelor’s degree from Rutgers University.
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Recent advancements in the self-collection of blood are allowing trial participants to provide a blood specimen for clinical lab testing from their home without visiting a clinical trial site or having a home health professional visit them.
When considering adding self-collection of blood as a decentralized trial solution, stakeholders primarily aim to enhance the patient experience and engagement. Doing so successfully requires early engagement with the clinical lab team during trial design. Lab teams can help assess the availability of specific tests, as well as apply any needed adjustments to clinical and operational strategies to uphold patient safety and specimen quality without creating additional burdens for themselves or patients.
Test menu development
Before all else, clinical lab teams must conduct feasibility and verification studies to determine if lab test values obtained via venous blood, collected by a phlebotomist, correlate with lab test values obtained via capillary blood, collected by self-collection devices. Currently the most common application for the use of blood self-collection is pharmacokinetics, or PK, testing, but safety testing is emerging as another option, and many other tests are being studied in a self-collection format. Clinical trial sponsors are encouraged to discuss the use of self-collection approaches for lab testing with regulators prior to using it for diagnostic purposes.
Enhanced site support
Shifting from a traditional trial approach where patients’ specimens are collected and processed by a trained nurse or phlebotomist, self-collection requires site teams to ensure trial participants know how to properly collect, package, and ship specimens to the lab. Because of this shift in site responsibilities, during trial planning, the laboratory project manager and their team must work closely with the study project management team to coordinate with the different trial sites that will be educating patients on correct self-collection methods.
Specimen processing and shipment considerations
Specimen processing and shipment requirements vary by test. For example, safety testing usually requires that samples be centrifuged prior to shipping them to the lab, and exploratory biomarkers often require specimens to be frozen prior to shipment, while PK testing may be possible via dried blood.
Clinical lab teams continue to evaluate packaging options, shipping temperatures, dried blood vs liquid blood formats, and approaches to centrifugation. For example, we conducted a feasibility study to determine whether we could forego the use of portable at-home centrifuges needed for safety testing analytes by delaying the centrifugation step until samples reach the lab. The study showed that delayed centrifugation was acceptable for some analytes but not others.
Additional research is needed to examine the viability of different processing options, including lab centrifugation, at-home centrifugation, and specialty couriers who can pick up specimens at a study participant’s home and immediately place them on dry ice.
Toward patient-centered approaches
Looking ahead, there is no doubt that there will be added advancements in decentralized trial self-collection devices, available tests, specimen processing approaches, and shipment methods. And clinical trial teams must consider how these evolving patient-centered approaches may impact safe and quality specimen collection, processing, and analysis. Ongoing feasibility studies are providing added insights into what clinical and operational practices will be necessary to ensure effective and safe processes for self-collection without increasing burdens to sponsors, clinical lab teams, trial sites, and most importantly, study participants.