Clinical trials require devices, lab kits, and associated supplies, diagnostic equipment, shippers, freezers, centrifuges, and investigational product (IP). These items, which we refer to as clinical trial inventory, are absolutely crucial to the success of a study. However, the process for managing these supplies at most clinical research sites is chaotic due to labor-intensive, manual, and inefficient processes, as well as a lack of communication and coordination with suppliers.
This week's blog explores the vicious cycle of excess supply, expiry, waste, and manual tracking and reordering at clinical research sites — and its direct impact on site operations and trial outcomes.
"Breaking a vicious cycle always requires an act of conscious intervention."
— Jeffrey Kluger
A "vicious cycle" refers to a negative pattern of behavior or events that repeat themselves, often leading to further negative outcomes. These cycles can be difficult to break because they become systemic. In today’s society, there are many examples of these self-perpetuating cycles:
Change requires action and conscious effort. To break a vicious cycle, we must be willing to take intentional steps to disrupt the pattern and create a new, more positive path forward.
In the pharmaceutical industry, there is a large emphasis on the IP, or study drug, in a clinical trial. These drugs can be very expensive, and there is a lot of rigor around their supply chain. Efforts are made to minimize waste and ensure clinical research staff always have the study drug on-site for the patient visit. RTSM (randomization and trial supply management) and forecasting systems aim to resupply sites based on patient enrollment and projected demand.
The supply chain for all the other items required to run a smooth and effective clinical trial is still mainly managed on paper and spreadsheets, leading to a vicious cycle of excess supply, expiry, waste, and manual tracking and reordering.
Rather than receiving clinical inventory commensurate with patient enrollment, it is fairly common for sites to be sent bulk shipments of lab kits and associated supplies (shippers, etc.) at study-start, which are meant to last the duration of the trial. Since sites don’t have visibility into what, when, or how much supply they will receive, they quickly run out of valuable storage space and end up stacking boxes in every pocket of available space — on top of shelves, under desks — and as a result, they have difficulty locating kits and other supplies when needed for patient use or safe disposal.
As sites begin to enroll patients, their staff realizes that many of the kits have expired, or they have too many of the wrong kits and not enough of the right ones. This creates several problems for clinical research staff. They try to proactively manage their inventory by creating their own manual tracking systems, which are error-prone and labor-intensive to manage. They spend time and resources breaking down and destroying the expired kits. Additionally, there is a common practice whereby sites create frankenkits so they don’t have to turn a patient away or take a deviation. While this solves an immediate problem, it perpetuates the issue of waste as the leftover items in the kit now become unusable and must also be thrown away. Third, if sponsors issue a recall for certain kits or other inventory, site staff must painstakingly locate all the recalled kits across their inventory in order to dispose of them.
As a result, site staff must manually reorder inventory to replenish what was disposed of or what will be needed based on new enrollment data. Resupply requests made for a small number of items are often overfulfilled in unnecessarily higher quantities, which only perpetuates the cycle of excessive supply, expiry before use, massive waste, and manual ordering.
Change requires action and conscious effort. To break a vicious cycle, we must be willing to take intentional steps to disrupt the pattern and create a better, faster, and stronger path forward.
Addressing this problem is one of the reasons why Slope was founded.
It is time for clinical inventory management at the site to be treated with the same rigor applied to the clinical drug supply chain. Sites should have all the supplies they need, when they need them — inclusive of devices, lab kits, and associated supplies, diagnostic equipment, shippers, freezers, centrifuges — and (not just) IP.
Replenishments should be automatically sent to the site as lab kits and associated supplies are consumed by patient visits. Triggers and notifications help inform site staff of the location of supplies, upcoming expiry, and which supplies to use first. Lastly, when supplies are recalled, sites should know exactly how many they have and where they are located, and those recalled items should be automatically removed from usable inventory.
Breaking this vicious cycle reduces waste, improves patient engagement and retention, and enables clinical researchers to spend more time with patients, and less time dealing with paper and fighting fires.