Considerations for Laboratory-Related Operational and Patient Burden in Decentralized Clinical Trials. Clinical Lab Testing in Your Home: Fact or Fiction?

Decentralized clinical trials (DCTs) have taken a major step forward during the pandemic, helping to enable clinical research despite restrictions on travel and investigator site visits. Approaches including remote recruitment and data collection, close-to-home specimen collection options, and connected devices, have enabled trial participation while minimizing the need for patients and study personnel to travel. These options have advanced patient centricity by bringing the study to the patient, offering benefits that will be valuable even once pandemic-related restrictions are lifted.

Authored by experts from Q² Solutions, this article focuses on challenges to address for successful laboratory specimen collection at or near the trial participant’s home.

Many operational and patient-related factors must be accounted for when using a decentralized approach to specimen collection. Clearly, the protocol must either allow for DCT visits or be adjusted to enable these. Some study visits may be suitable for DCT approaches, while others may not, for example, if a clinic-oriented procedure is required. Depending on cost-benefit and patient burden considerations, a suitable location for specimen collection must be determined – whether at the patient’s home, or at a central setting such as a retail store, patient service center, or pharmacy. Generally, a phlebotomist visit costs less than a nurse visit, but nurses are able to provide a wider range of services.

Specimen processing and shipment 

Specimens may require preparation before sending to the lab, such as centrifugation or incubation. Depending on the homecare provider, couriers may be managed by the home care provider or by the central lab. Specimen stability varies by type of specimen and testing requirements; therefore, shipping temperature and transit time must be considered.   Certain specimens are stable for days or weeks at room temperature, whereas others must shipped cooled or frozen, and patient location must be considered to assure the feasibility of a home collection for each patient.

Choice of specimen collection kits 

Since some protocols provide flexibility to patients and investigators to choose whether to have a home visit or a site visit, some study teams have requested the use of generic kits, which are not investigator specific (and sometimes not visit specific), in order to potentially reduce kit wastage. The use of generic kits increases the risk of human error since it requires a manual approach from home care personnel and the central lab to ensure that queries, lab results, and alerts reach the appropriate investigator in a timely manner.  Other study teams opt for standard investigator and visit specific specimen collection kits to minimize the chance of human error risk.

Multiple Time Points

The length of time to be spent at the specimen collection location must also be assessed. Collecting pharmacokinetic (PK) samples, for example, may require multiple time points over many hours. Depending on the resulting patient burden, this may or may not be acceptable.

Self-collection of samples by the patient

At-home self-collection of blood and other samples is an option that is currently in its infancy. Self-collection of blood in clinical trials could reduce patient burden and improve recruitment and retention by reducing the number of home or site visits.

Potential concerns around self-collection include regulatory readiness, technology readiness, and process readiness. From a regulatory perspective, not all devices are suitable for all jurisdictions. Devices typically collect capillary blood, while current tests require venous blood. Many companies are working to create tests that can utilize capillary blood, assure patients can receive the appropriate support for self-collection of blood, and assure labs can receive and test samples from these devices in a robust and automated fashion.

Devices are in development to simplify self-collection of blood samples, each with slightly different approach, including lancet-based finger pricks, dried blood collection devices, and liquid blood sampling from the upper arm. The devices that self-collect liquid blood via the upper arm enable larger sample volumes, which may make them better suited for chemistry panels for safety testing. Blood may also be self-collected on a porous surface, producing a dried sample, which may help stabilize samples for ambient shipment for PK testing.

In the future, as self-collection of samples in clinical trials expands, innovative approaches to assure sample integrity are under consideration to be built into devices and/or processes.

Towards lab testing at the kitchen table

Currently clinical trials utilize connected devices such as step counters, pulse oximeters, thermometers, weight scales, electrocardiogram devices, and continuous glucose monitors, but several companies are working to enable the kind of lab testing currently only available at brick and mortar labs, at our kitchen tables. These point of care testing (POCT) devices, intended for home lay person use, are being developed for tests like complete blood counts (CBCs), safety testing, and even biomarker testing. If these POCT devices reach the market, the clinical trial laboratory sector needs to be ready to adopt this technology, manage distribution, support patients, and enable data connectivity. In the meantime, DCTs – with the support of labs and at-home sample collection – show promise for advancing patient centricity in clinical research that will last way beyond the pandemic.

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