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September 10, 2020

Direct-to-Patient (DtP) in Review – What Would We Have Done Differently if We Knew COVID-19 was Coming?


COVID-19 was not expected. There was a domino effect across the globe that was not lost on the pharmaceutical industry. The question quickly arose, “How do I continue to deliver medications to patients who need them if they are unable or unwilling to travel to the clinical site?”

The immediate solution? Most pharmaceutical companies manually implemented direct-to-patient (DtP) models. While the concept of DtP is not new in the industry, it wasn’t until recently that the execution of these models became mainstream. With other critical components including patient re-consent, protocol amendments and trainings to tackle, it was the fastest way to ensure trial continuity.

But here we are months later. Some parts of the world have opened back up, while others continue to struggle. There is a high probability of a second wave. How do we go from being reactive (where we were early in the year) to proactive (looking forward to the second half of 2020)?

The questions is no longer how do I deliver medications to those who need them, but how do I do so better, safer, and more efficiently. Now is the time to take stock of what we’ve learned over the last few months and ask ourselves what we would have done differently if we had seen COVID-19 coming. Would DtP still be the correct approach? If so, is manual the best solution or is there a way to automate the process? And, what solutions are available to assist?

While there many facets to an ideal solution, here are 3 reasons why you should leverage a randomization and trial supply management (RTSM) to execute direct-to-patient models.

1. Unparalleled Flexibility.

Modern, fully configurable RTSM solutions not only allow you to turn the feature on and off as needed, but they allow the model itself to be flexible all the way down to the individual patient level. Letting the patient opt-in to a DtP approach gives them a voice in their own care.

2. Choose any Model (or mix of models), Including Depot-to-Patient.

While not every country allows Depot-to-Patient, in some cases that approach is the best course of action where applicable. For example, when smaller sites started closing down during the COVID-19 pandemic, a site-to-patient approach was not feasible. Sponsors had to be creative to bring medications to their patients. If a Depot-to-Patient model was available, drug can be dispensed from depot inventory while taking into account regulation/regulatory restrictions. A modern RTSM allows any combination of DtP models as needed for the study.

3. Patient privacy.

Patient privacy is a top concern, especially when handling personal information like home address. Unlike manual collection and storage, an RTSM system ensures all data is encrypted in one place, with no manual work required. In a system, all data privacy regulations are followed according to GDPR and HIPAA requirements to ensure patient information is protected.

Choosing a modern, fully-configurable solution with the flexibility to support DtP functionality, will allow you to follow the science and the circumstances you are in – not the other way around.

For more info download our DtP white paper.



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