Webinar Q&A

Q: In a DtP setup, are timelines longer for delivery to patient?

Generally DtP timelines include the so-called “last mile” to the patient home, yet this may or may not equate to longer timelines. Having specified that, in the current restrictions due to the COVID-19 pandemic, additional buffer time is factored in as contingency planning due to current mobility restrictions in several countries. Where possible, we endeavour to keep the timelines as realistically short as possible, taking also in account the urgency of the DtP shipment.

Q: What are the critical parameters to successfully setup a DtP supply chain?

In a standard DtP setup, apart from the sponsor’s responsibility to comply with MoH (Ministry of Health) requirements, the critical operational parameters required are: protocol number(s), list of countries, number of patients, location of patients, frequency of shipments, duration of the study (expected start and end date), temperature conditions, packaging requirements. In the current COVID-19 emergency scenario, although startup timelines may be tighter, it is even more important to capture these details for a successful implementation of the DtP supply chain.

Q: How easy (how quick) is it to switch from a traditional clinical supply chain to the DtP model?

This is generally a relatively straightforward switch, if this if contemplated as a potential option in the study protocol. From a logistics perspective, once the operational parameters are known (and once the sponsor has gathered all necessary approvals), this can be switched as soon as the request has been setup in the logistics systems. During COVID-19 many governments have loosened local regulations to accommodate the DtP model to ensure patients continue to receive their supplies.

Q: What are the most common restrictions or challenges you have experienced on implementing DtP?

Once the regulatory requirements of the MoH are met, currently the COVID-19 restrictions are mostly due to limited airfreight carriers and access to red zones/ lockdown areas. World Courier has implemented a contact-free and a signature-free procedure to ensure the safety of both the driver and the patient.

Q: We are planning DtP for a project via account set up by the site. This is because we are concerned about Sponsor receiving invoices with patient identifiable details. Is there an option for Sponsor to set up the account and pay the cost of DtP without receiving patient identifiable data?

Patient confidentiality and data privacy and paramount in a clinical study. World Courier has setup dedicated procedures where patient information is anonymised in invoices guarantee cost overview and control in the respect of patient privacy and data management

Q: About temperature controlled shipments, how can we download the data after the monitor is removed? How can we ensure temperature critical injections are viable through DtP?

For deliveries with temperature loggers there are two different approaches, depending on whether a nurse is present or not at the patient’s home. If a nurse is present as part of the home care model, then the nurse would be trained in the procedure. If a nurse is not available, the driver would take care of stopping the temperature monitoring device in respect of contact free procedures. Regarding injections, the administration methodology would need to be specified in the study protocol, in both scenario: with a trained nurse or without.