Critical Packaging and Labeling Considerations for Decentralized Clinical Trials

Decentralized clinical trials (DCTs) have emerged over the last several years as a powerful method of increasing access and engagement in clinical trials. In fact, many sponsors are leveraging at least some decentralized elements — such as remote monitoring, telehealth, and home healthcare visits — alongside on-site components to suit the needs of a given trial and a product’s target population. 

However, the operational differences between DCTs and traditional trials give rise to unique logistical considerations that many sponsors may not yet be equipped to manage. Among these, labeling and packaging must be approached thoughtfully due to the varied needs of shipping and distribution associated with DCTs. Key considerations in this area include kitting, just-in-time labeling, and blinding.

Kitting to equip sites and patients

Providing kits for DCTs is a common way to ensure that study sites and patients have the materials needed to fulfill their responsibilities. These kits can include a wide range of supplies, customized to meet protocol requirements. 

Kitting is especially important in DCTs, in which patients may need to complete some actions at home. Additionally, certain DCT activities might have to be conducted at a local healthcare facility that uses different equipment than others involved in the same trial, or may not have the exact tools required by study protocols. Because it is not always possible to assume what resources will be available at each location, kits must include all essential materials.    

Further, if patients are expected to use any portion of the kit on their own, without a healthcare professional present, it is important that all contents be clearly packaged and labeled. This ensures that participants with limited experience will easily identify and use the correct items when needed. Even during telehealth-supervised portions of the trial — in which the clinician will not be physically present — intuitive labeling and organization will help the process proceed more smoothly and efficiently.

Improving efficiency with just-in-time labeling

Just-in-time principles involve performing certain tasks — such as labeling and packaging — only shortly before they are needed, rather than well in advance. This approach offers greater flexibility for last-minute changes, and conserves resources by using only what is necessary. In DCTs, in which participant enrollment, withdrawal, or site assignment can change frequently, just-in-time methods help ensure materials are accurately prepared and sent to the appropriate location. 

This is especially true for just-in-time labeling for DCTs, in which product labels must reflect the most accurate and current information possible. When variables such as site details change, labels must be updated accordingly. Just-in-time labeling allows products to be labeled at the time of shipment preparation, avoiding time-consuming and resource-intensive relabeling. This approach is particularly effective when packaging, labeling, and shipping are managed by the same logistics partner, enabling faster and more efficient delivery.

Maintaining the blind in decentralized settings

As is the case with other clinical trials, DCTs must maintain a blind — meaning that patients and clinicians should not be able to tell whether an investigational product, comparator drug, or placebo is being administered. To that end, products and their packaging should be as identical as possible, preventing those overseeing administration from discerning any differences.

Additionally, for DCTs, logistics providers must be very conscientious about packing slips, which typically contain information about what materials are sent to a given site. When a shipment is sent straight to a patient, or a site with very few participants, these slips put the blind at risk. As a result, transportation and logistics providers must have procedures in place to ensure that such sensitive information is sent only to appropriate representatives of the sponsor — for example, by omitting packing slips from patient-facing shipments and ensuring documentation is sent only to the correct representatives.

Expert support for DCTs

To best prepare for the specific packaging and labeling requirements of DCTs, sponsors should seek out an experienced logistics partner, such as Yourway, that understands the nuances and challenges involved. With integrated systems in place across the value chain and a team well-versed in DCT compliance, an expert provider can ensure the entire process is streamlined, reliable and expertly managed.

To learn more about packaging, transportation, and patient privacy considerations for DCTs, read Yourway’s white paper, Logistical Coordination in Decentralized Clinical Trials.