04 Jul 2022

Direct to Patient deliveries

We live in a big world that's getting smaller every day in many ways.


In the past, people travelled to participate in human clinical trials. Nowadays clinical trials can come to people thanks to advancements in technology, new and exciting markets and, of course, superior logistics services.


Decentralised trials are changing the face of clinical research, making it more accessible to diverse patients over a wider geographic spread. DCT’s break down barriers to participation for many patients who wouldn’t previously have had access to life-changing research opportunities.


It’s a complex process. Careful planning, with special focus on the importance of risk management, is essential. Effective supply chain management is the key to success in Direct to Patient delivery.


There are many considerations – like maintaining drug stability during transport; security – prevention of unauthorised access and tampering; temperature and dose tracking and timely refills.


And there are always unexpected challenges – what do you do if the patient isn’t there to receive delivery? How can you know if the cold chain temperature-controlled transportation is compromised in transit? And if so, how quickly can drugs be replaced?


Some deliveries are more straightforward than others – the direct transportation of medical equipment, for example. However sometimes alternatives to DtP are required, like in cases where very strict temperature controls are needed or perhaps there is a lack of clear regulatory guidance. In cases like these, sometimes depot-to-site shipping is the solution. The final deliveries, and all of their inherent challenges, are then taken care of in a one stop solution at the end of the transport line.


So, what’s the future for DtP deliveries?


Many CRO’s and sponsors dealt with unprecedented disruption during the pandemic by turning to DtP and the proven safety of its use means that it’s likely we’ll see more regulatory approval for these types of shipments.


New technology is being developed including advancements like remote access drug refrigerators that track patient access, caps that record when a drug vial is opened and over-encapsulation products that report when a patient has taken their medication.


The growth of hybrid trials is also expected, blending the virtual and the actual in patient focused trial models.


Trial sponsors will need to weigh the increased benefits of easier patient access with the higher costs of DtP shipments. One benefit is for sure, however, and that’s the advantage of putting people at the heart of clinical trials.

Working with patients can be key to making treatments work for them.