Direct-To-Patient Trials Are Changing The Clinical Supply Chain
By Laura Hay, senior director of global program management, Trax Group | 2025 Winner, everywoman Customer/Passenger (Leader) Award
One of the biggest changes happening in clinical research is also changing the way we need to think about clinical supply.
For decades, the clinical site has been at the center of the supply chain. Investigational product is manufactured, packaged, and distributed through a network of depots before ultimately reaching the site. The process is structured around a relatively controlled environment, with trained staff responsible for receiving, storing, and dispensing the product. As clinical trials become more decentralized, that model is beginning to change.
When investigational product is delivered directly to a patient's home, the supply chain no longer ends at the clinical site. It extends into an environment that is much harder to control, and that has important implications for everything from forecasting and inventory positioning to transportation and patient experience.
Direct-to-patient distribution can make participation easier for patients, particularly when frequent travel to a clinical site creates a barrier. But operationally, it introduces a completely different set of considerations.
A shipment going to a clinical site follows a known process. A shipment going to a patient's home has to account for whether the patient will be available, whether the product requires specific storage conditions, what happens if a delivery is missed, and how quickly another shipment can be arranged. Those details may sound small, but across a large clinical trial they can become significant supply chain considerations.
The shift also changes the way we think about demand. Traditional site-based distribution provides a certain level of structure around ordering and inventory. With direct-to-patient models, consumption can be more difficult to anticipate. Patients may enroll at different rates, discontinue treatment, change dosing schedules, or require different delivery arrangements. A protocol amendment can also change demand across the network. This makes flexibility increasingly important.
Rather than simply asking how much inventory a trial will need, supply teams need to consider where that inventory should be positioned and how quickly it can move if demand changes. Holding too much product in one location can create waste or expiry risk, while holding too little can create service problems if demand increases unexpectedly.
There is no single inventory model that works for every decentralized trial. The right approach depends on the therapy, patient population, geography, lead times, and product requirements. What does matter is having the ability to adjust the strategy as the trial evolves.
I also think the patient experience needs to become a more visible part of the supply conversation. It is easy to look at a shipment and define success as "delivered on time." From a patient's perspective, that may not tell the whole story. Was the delivery convenient? Did the patient know when it was coming? Could the product be stored appropriately? What happened when the delivery was missed? These operational details can influence how easy or difficult it is for a patient to remain engaged in a trial.
That means clinical supply teams need to work closely with clinical operations, technology providers and logistics partners. The supply chain cannot be designed independently from the patient experience.
Technology will obviously play a role. Better shipment visibility can help teams understand where product is in the network. Real-time information can provide earlier notice when something has gone wrong, while predictive analytics can help identify changes in demand before they become an immediate problem. But implementing technology without changing the underlying processes isn't enough.
If an organization takes a traditional site-based distribution model and simply adds a direct-to-patient delivery component, it may still be operating with assumptions that no longer fit the trial. The network needs to be designed around the realities of decentralized participation from the beginning. That includes thinking about regional inventory, delivery partners, contingency options, and escalation procedures. It also means understanding what happens when the ideal scenario doesn't occur.
What happens when a patient isn't home? What happens when a shipment is delayed? What happens when demand increases in one region? How quickly can product be repositioned?
Those questions are much easier to solve when they are part of the original supply strategy rather than something addressed after the first problem occurs.
The move toward decentralized and hybrid trials is ultimately about making clinical research more accessible and patient-centered. The supply chain needs to evolve alongside that goal. As product moves closer to the patient, supply teams have to think beyond traditional site logistics. Forecasting, inventory, transportation, technology, and patient experience are becoming increasingly connected.
The future of clinical supply will not simply be about getting product to the right clinical site. In some trials, it will be about getting the right product to the right patient, at the right time, while maintaining the quality and control that clinical research requires. That is a very different supply chain — and one that needs to be designed intentionally.
About The Author:
Laura Hay is senior director of global program management at Trax Group and the 2025 winner of the everywoman Customer/Passenger (Leader) Award. With extensive experience in clinical supply chain and program management, Laura focuses on helping organizations navigate complex global supply environments, improve operational visibility, and build more resilient approaches to clinical trial supply. Her expertise spans clinical supply planning, forecasting, inventory agility, global logistics, and the evolving challenges facing life sciences organizations.