The growth of DTP (direct-to-patient) and DFP (direct-from-patient) supply chain services in recent years has been in response to the need for minimal disruption to the patient’s lifestyle while increasing their willingness to participate in a clinical trial.

Patient behaviour, expectations and technology are driving the strong interest in virtual trials. Streamlining logistics, the strategic involvement of supply chain partners in the protocol design, and simplified patient-centric services, form the new model for planning a successful clinical trial. The main challenges associated with DTP and DFP services are often the lack of control over temperature-sensitive materials. Critical questions need to be addressed when considering adding a DTP protocol to a trial, such as how can all partners invovled effectively coordinate the different parties connected to the patient – site, logistics courier and home-care provider – or ensure patient data protection and privacy is maintained throughout the study across different suppliers?

Planning ahead

Sponsors need to understand the common regulatory challenges associated with home care, and DTP and DFP strategies. By exploring the set-up process for a successful trial and to avoid risk, critical points in operationalising home care and the last mile of the supply chain need to be addressed. Assess each protocol to verify which are most appropriate for DTP and DFP, and home healthcare, and review the types of procedures commonly conducted in home care. Patient data protection and privacy can become a potential pitfall. Marken continues to lead the industry in DTP and DFP supply chain solutions to meet the growing demand from the clinical trial industry.

Marken has demonstrated its ability to effectively manage drug product delivery to and biological sample pickup from patient homes, having adapted systems and processes to be compliant with patient privacy regulations. Pharmaceutical companies are becoming comfortable with the DTP service and it is Marken’s belief that the majority of clinical studies will eventually be conducted with a DTP, DFP and home healthcare service feature.

As the clinical trial industry moves towards more personalised treatments, Marken is ensuring its services evolve for these more complex and specialised trials. DTP services are the fastest-growing part of the business. The company currently manages more than 1,600 DTP and DFP monthly deliveries in 51 countries.

Signed, sealed and delivered

Marken recently announced a new service that allows nurses to drop off clinical trial samples at UPS store locations across the US. Nurses are able to drop biological samples with various temperature ranges at local UPS stores that serve as a conduit for direct shipment to the selected central or speciality laboratory.

Close to home

Marken recently announced the development of its global home-based nursing network to supplement its existing services. The new home healthcare offerings includes intravenous infusion; blood draws; biologic sampling, such as pharyngeal and oral mucosal swabs; and the clinical assessment of vital signs and other mobile-based electronic data collection. The 24/7 Patient Communications Centre (PCC) and Marken’s Viseo application enhance these services. The Viseo online interface allows patients and nurses to track their home deliveries of clinical trial materials and the pickup of their biological specimens via their mobile device or personal computer. Real-time driver traceability can translate into improved patient expectations and confidence with hybrid or virtual trials, and reduce the number of rescheduled deliveries and delays.

Marken has actively managed supply chain solutions for DTP trials since 2012, and has expanded its expertise to provide services throughout the world. It continues to anticipate the future needs of clients and patients alike. Marken recognises that the supply chain is a critical link in today’s changing clinical trials environment. With its growing experience in DTP and DFP trials, coupled with a history of high touch, personalised service, the company will be able to reach populations in remote areas through home-based clinical trials with an unwavering commitment to patient safety and privacy.