Scientists rely on clinical trials to test and prove nearly all medical innovations. New, groundbreaking drugs and therapies must go through these trials in order to make it onto the market and into the hands of the patients that need them most. Over the last few years, however, conducting clinical trials has gotten trickier.
A typical clinical trial involves bringing patients to a centralized location, generally a hospital. This type of model can prove expensive and generally challenging, especially in the throes of the coronavirus pandemic. Patients are more hesitant to participate in trials, as they fear getting ill at the hospital. Additionally, hospitals are severely short on the beds needed to conduct on-site trials.
There has been a 40% drop in clinical trial patient retention in recent years, according to Arnold Bernard, World Courier specialty group senior manager. Currently, 1 in 4 patients drops out of a trial before completion, which can have a profound impact on the study as a whole.
This is where decentralized trials come into play. With these trials, the focus is on bringing a therapy to a patient’s home in order to best support him or her or encourage continued participation in the trial. Decentralization provides a wide variety of benefits for everyone involved, including the patients who can continue their normal daily activities, hospitals that do not have to sacrifice space and sponsors that see higher compliance and completion rates.
While decentralized trials seem like a win-win-win, one of the biggest concerns surrounding this model is the safety and integrity of the drug when it is shipped to the patient’s home. This direct-to-patient model relies on a robust logistics strategy to support product viability and security.
“It is critical to partner with a logistics company that is not just efficient in logistics but equally, if not more, adept at quality management,” Bernard said. “It doesn’t matter if a product arrives on schedule if the integrity of the product is compromised.”
There have been tremendous advances in the different types of packaging material and monitoring devices available to get these drugs – including fragile cell and gene therapies – to the appropriate temperature and ensure they hold the temperature throughout transport.
Logistics providers should be familiar with these necessary solutions, but they must also work with the manufacturer to ensure they are capable of safely handling each individual drug they will be transporting. This is generally done through a project onboarding phase.
Going through an intensive onboarding phase allows logistics providers to get familiar with the products and learn to manage environmental needs in several different situations, including drastic outdoor ambient temperature changes and customs clearance hassles. Providers should also be aware of any changes to regulations of airline services that may impact the project in the future.
Moving advanced therapies and clinical trial drugs requires a significant amount of familiarity, and establishing dedicated partnerships usually works out better than trying to move these products on a transactional basis, according to Bernard.
Dedicated partnerships in this space tend to minimize costs and general concerns, while inspiring innovation. Logistics providers who work with these goods consistently will be much more likely to pursue new solutions around them than providers who do only handle them occasionally.
“What this really calls for is a true partnership approach as opposed to a client-vendor relationship because success is really tied into the collaboration of all parties supporting the delivery of these therapies,” Bernard said.