Direct-to-patient services in practice: COVID 19 case studies

The Covid 19 pandemic has placed additional emphasis on the healthcare industry shift towards more patient-centric approaches, particularly with clinical trials. Increasingly, services such as Direct-to-Patient (DtP) and Direct-from-Patient (DfP) shipment approaches are now being viewed as critical. Delivering Investigational Medicinal Product (IMP) to patients participating in clinical trials requires the establishment of a framework to ensure the safe and compliant delivery of the IMP, with particular emphasis on patient safety and adherence to the relevant National Competent Authorities acceptability.

So how does it all work in practice?

The Wasdell Group has worked closely with clinical trial sponsors and the relevant authorities to tailor DtP as well as DfP services for clinical trials. By adopting these approaches, existing studies were able to proceed despite COVID 19 restrictions, and new studies were able to commence. Examples of recent case studies highlight the benefits –

Direct-to-Patient (DtP) case study:

Wasdell recently worked with a sponsor to provide IMPs through DtP services, enabling home treatment while avoiding footfall at hospitals and clinical settings and protecting vulnerable patients.

Patient safety is always paramount, and considerations included clinical oversight of the administration of the medication, as well as monitoring & reporting adverse events, while protecting patients by limiting unnecessary social interactions.

With that in mind, Wasdell started by reviewing the IMP trials and any potential patient concerns to ensure the DtP approach would meet the necessary safety criteria  – capturing process challenges associated with the dispatch and transportation of IMP, as well as accountability throughout the DtP process.

As updated guidance became available from each National Competent Authority as a result of the COVID-19 pandemic, the framework for this DtP service developed – with constant refinement and adaptability needed from the delivery teams to ensure that trials could continue to run compliantly and efficiently.

The DtP model allowed the trial patients to continue to be recruited and provided with IMP on time, direct to their homes, with clear information about how to administer and use the product.

Direct-from-Patient (DfP) case study:

DfP services can also enable the benefits of a more virtual, remote service – providing solutions for returns, reconciliation and destruction of clinical trial materials from patient homes.

Wasdell recently collaborated with a sponsor that was aiming to implement DfP services during the COVID-19 pandemic. Due to the nature of the service, emphasis was placed on full traceability from storage conditions and administering of the medication at home to receipt back at the centre. It was also vital that the packaging information was clear and accurate, and in this case patient training was also necessary.  Open channels of communication were pivotal to the success of trials, with patient support sponsors in direct contact with patients and caregivers to ensure training and trial adherence.

Additionally, Wasdell’s Quality Management System (QMS) was used to successfully manage the project, ensuring all risks were assessed at various stages during the returns process. The final solution included arranging collections with full tracking and traceability, and returns of IMP materials for certified destruction.

Looking to the future

It is evident that COVID-19 will continue to impact clinical trials, necessitating the long-term need for services such as DtP and DfP. The industry must also consider the many benefits passed on to patients through the implementation of these services – notably seen through a shift towards a more patient centric approach to allow for a better patient experience. Once regarded as unrealistic, these services have proven themselves to be viable and valuable, and ultimately incredibly effective strategies for successful clinical trials.

A good partner, like Wasdell, will offer solutions-driven support and find ways to deliver a personalised approach to meet trial sponsors’ and patients’ needs. Find out more about our other clinical services here: https://www.wasdell.co.uk/wasdell-clinical-services/

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