Adapting drug supply strategies to modern study models
Decentralized trials (DCTs) make clinical research more accessible to diverse and geographically dispersed patient populations. By taking trials directly to the patient, barriers to enrollment can be eliminated and participation can be continued, which benefits patients and can help accelerate the pace of drug development.
As DCTs are scaled, the industry also encounters unique challenges, particularly within pharmaceutical clinical supply chains. The success of any study hinges on effective supply chain management — getting the right drug to the right patient at the right time in the right condition. That’s complicated work. And it becomes more complicated for DCT management, which requires shipping to multiple coordinating sites and directly to patients’ homes.
So Parexel adapts our practices to fit direct-to-patient (DtP) models. And we’re working flexibly as regulators identify and address emerging DtP considerations. Through all of the change, however, our mission remains the same: supporting patients and their care teams through the consistent, convenient delivery of drugs and other trial supplies.
DtP drug shipments require layers of planning to maintain drug stability during transport. Providers also need ways to prevent unauthorized access, detect tampering, track temperature and dosing, and provide timely refills.
When facing such complexity, risk management becomes incredibly important. What happens if a patient isn’t home to accept a drug delivery? Or if a family member wants to sign for the shipment? If the temperature control system is compromised in transit, how will we know? How quickly can the compromised drugs be replaced? For every step of the process, we brainstorm possible obstacles and how to best handle them.
Some materials, like sample collection supplies or wearable devices, can be direct-shipped fairly easily. But there are situations in which alternatives to DtP deliveries are needed. For example, direct-shipping a drug that requires very strict temperature controls might create significant risk for product integrity. In such cases, to better serve patients, we’ve used depot-to-site shipping, with sites coordinating the final distribution.
Depot-to-site shipments are also a good option when clear regulatory guidance is lacking. For example, study medications may need to be distributed to patients in multiple states in the U.S. The FDA hasn’t clarified whether a trial-affiliated pharmacist is needed in each state to which the drug product is shipped — so if there’s a lack of pharmacists, it might be prudent in some cases to use site shipments, with clinical teams allocating drugs as appropriate.
There is precedent for regulatory approval on some DtP shipments. For example, when the COVID-19 pandemic forced the closure of clinical trial sites in Malaysia, Parexel was able to ship drugs directly to Malaysian patients from neighboring Singapore. Prior to this time, cross-border shipments were unusual, and our global trade compliance teams worked very closely with regulatory authorities in both countries. Ultimately, the work was a success. During the pandemic, many sponsors and CROs demonstrated the safe use of the DtP model, so we believe wider approval for domestic and international DtP shipments will come.
We’re also anticipating new industry technologies that will enhance the direct-ship patient experience. These include remote-access drug refrigerators that track patient access, caps that record and relay when a drug vial is opened, and over-encapsulation products that report when a patient has consumed a medication. While these innovations are still in the exploratory stage, they show our industry’s commitment to patient-focused, forward-thinking solutions.
And that commitment applies to patient-focused trial models as well. We expect the continued growth of hybrid trials, blending the benefits of virtual medicine with some site-based activities. This flexible model can serve a variety of patients and needs. So for patients with chronic but more easily managed conditions, like diabetes or asthma, the study team might design a hybrid trial with DtP medication shipments and visits that are mostly remote. In a hybrid trial for patients with more complex needs, however, the protocol could call for wearable technology and some in-home sample collection mixed with occasional in-person appointments at the study site.
When planning a protocol, we consider the unique needs of the patient population. In some cases, patients will welcome the convenience of remote appointments and at-home medications. There are also patients who see site-based appointments as a benefit of clinical research — a chance for in-person attention from experts in their therapeutic area. We weigh those wants as we design a study. Understanding patients helps determine our success.
Cost also factors into supply chain planning. Because DtP shipments must be delivered to many individuals, they are more expensive than depot-to-site shipments, which occur in bulk. The tradeoff, however, could be greater patient compliance and retention. Benefits and costs will be different for every trial and every medicine. In considering options, we’re looking for the best way to serve the patient while also managing risk and costs and ensuring data quality. That requires flexibility and a willingness to navigate complexity.
CROs can help manage that complexity, and there are many approaches. At Parexel, we streamline drug supply through our dedicated network of international depots, which gives us greater control over clinical trial supply and logistics. Using a hub-and-spoke strategy, our larger distribution centers serve many outlying regions with speed and efficiency. We also have a team of professionals whose approach to logistics is informed by a deep knowledge of GCP and GMP regulations.
And those experts know that, to be truly valuable, an innovation must solve a problem for the patient. In many situations, DtP shipments simplify trial participation and make it easier to stay compliant. They’re one of the many tools we use to solve problems — for patients and our partners.