Flexibility has become a necessity in clinical trials. The trend of decentralization is a significant change for the industry and has grown increasingly common. While certain treatment or assessment visits still need to occur at the investigators’ clinics, others will be conducted at the participants’ homes or at local infusion or treatment centers.
While this is a more patient-centric approach and will increase trial retention, this strategy creates unique variables and thus requires appropriate kitting. Kitting can eliminate unknown challenges, resulting in pristine material for more accurate data compilation and analysis.
“The actual pattern of where visits will occur may depend on the subject and their proximity to their clinical site,” says Fiona Geiger, Vice President of Client Services at Yourway. “Kitting appropriately for either scenario, and unknown frequency, or having at home visit kits and clinical site kits supplied as appropriate is important.”
Design Considerations
There are numerous considerations that need to be addressed when designing a kit. This includes materials that will be used and in what order they will be used. It is also important to consider the various paths for the unused, used, and partially used IP kits to be returned for accountability and reconciliation. The goal of a successful kit design is to make it as easy as possible for the subject, his/her homecare provider, and the clinical site to use as directed while simultaneously ensuring as close to 100% compliance as possible.
It is crucial to fully understand how the treatment visit will be conducted in the patient’s home and be prepared with all materials needed to administer the IP and to complete the tests required. “This might be as simple as a dose measuring cup or syringe and needle, or as complex as requiring medical equipment only normally available at the clinical site for an infusion, for example a refrigerated centrifuge or water bath,” Geiger notes.
Incorporating in-home visits to patient homes requires diligence. Frequently, items that are normally available at a clinical trial are absent and must be provided. For example, courier pick-ups of lab samples are on a routine schedule at a clinical site but when the samples are drawn at the subject’s home, they need to be dispatched at the appropriate temperature from the home to the lab. Therefore, the shipping container, perhaps dry ice, and labeling for the shipment need to be included for the home care provider to use.
Variables addressed by appropriate kitting design are not always eliminated during the design phase, because almost every clinical trial changes course at some point from the plan to the actual execution, according to Geiger. “Adding new countries, increasing enrollment, requiring an additional lab test, adding a treatment arm, or switching out a component that investigators do not like or have complained about using are a few of the reasons we see kits needing to be changed or reworked mid-study,” she explains. “Flexibility and ingenuity are key to doing this well and are essential.”
The most reliable kitting designer is one with a dependable network of distribution and manufacturing sourcing partners that can identify the correct approved items by region/country and maximize the usefulness of each kit from a labeling and regionally approved perspective. Geiger adds that, during such times of transition from one global kit version to another, it is often necessary to produce country-specific, single-panel labeled versions as interim solutions, always keeping in the forefront that clinical supplies should not hold up or interrupt the enrollment and treatment of subjects.
Additionally, temperature-control demands create challenges to kit design, necessitating careful thought to the temperature considerations of the IP, as well as the consolidation of ancillary items with the IP in kits. When IP has a temperature requirement, it means that shipping to depots, sites, or patient homes will require a pre-conditioned certified shipping box and temperature monitor. These shipping boxes are expensive, and they increase the size and weight of the shippable unit immensely.
Shipping is a significant component in kit design when temperature sensitivity is a factor. Maximizing the use of each shipping container is critical to minimizing the distribution costs associated with a study. “It would be foolish to increase the size of an IP kit through the addition of components that do not require temperature control, such that only two kits (units of IP) fit in a given shipper, when, without the ancillary components, you could fit 10 units of IP in the same shipper,” Geiger explains.
With the use of an IRT system, ancillary kits can be easily dispensed together with IP units for a visit, without them needing to be physically combined. Yourway’s goal is to maximize the usefulness of every shipping box with items that require controlled temperature and ship items that do not require any controls for shipping in corrugate shippers that are lighter and less expensive.
Trials involving parenteral IPs have unique kitting considerations as well. Parenteral IPs (injections or infusions) include a certain type of syringe, needle, infusion line, and inline or syringe filter. “It is extremely important to keep these consistent across the global trial to minimize and eliminate all variability in the trial and for the safety of the subjects,” she continues.
The Virtual Variable
The entire clinical trial workforce has become more virtual, which brings unique challenges to kit design, notably proper storage and distribution.
“When the office space disappears, so do the opportunities to store and distribute items such as user guides, ancillary supplies, training kits, etc.,” says Geiger. “Site start-up kits, along with patient visit kits, are becoming more commonplace, with the IP depot and distributor providing the kitting and management of these items. Centralizing it all also cuts down on waste and time spent in oversight on the part of the sponsor or CRO.”
Choosing a Kitting Service Provider
Yourway is unique in this industry space because, as an integrated provider, the company not only supplies primary and secondary packaging, labeling, storage, distribution, and procurement throughout the world, but it also has an internal specialty courier transportation service. This enables seamless movement of supplies into and out of Yourway’s depots, expertise in importation and export, and direct-to-patient deliveries and direct-from-patient collections. Yourway is also equipped to handle all temperature requirements.
Geiger adds, “We have access to and relationships with large distributors, but also directly with manufacturers. This ensures we have access to the ancillary supplies required for the kits and study, during times or shortage and when allocations are being implemented by government authorities. We source globally and through all our depots in country and region. We will find the most cost-effective, reliable, and requirement-meeting solution for our customers and then deliver it consistently throughout the trial.”
Yourway assigns customers a single PM point of contact who oversees the entire process and ensures it is executed flawlessly, right to the point of delivery. Decentralized clinical trials are rapidly becoming the norm, and kitting design has become more critical than ever to eliminate the variables that are inherent in DTP and DFP. The right kit design partner will help ensure that your trial reaches its endpoint.
