What to Consider When Planning a Direct-to-Patient Trial

There are many benefits to implementing a direct-to-patient clinical trial. Increasing convenience for patients can increase recruitment, which in turn increases the ability to effectively test more treatments and get new therapies to market sooner.

Nevertheless, direct-to-patient trials pose a challenge due to added complexity in material and patient logistics. Sponsors and CROs need to consider the regulatory context, various scenarios that come with this overall strategy, and choose depot and IRT partners that can properly support your trial’s unique needs.

 

Research Regulatory Requirements

The first area to understand when considering direct-to-patient trials are the regulatory requirements of the different regions that are going to be participating in the trial. This drives your DtP approach and could add complexity as it could cause differences in strategy by country or region.

 

Anticipate Risks

It’s important to manage risks associated with the direct-to-patient model including, for instance, the more complicated unblinding scenarios that may arise, as well as handling the patient identifying information necessary to run the trial properly

Consider this scenario in an unblinding study: a site or depot cancels a shipment intended for patient 1 and then instead ships those drug units to patient 2. A site user becomes aware that these two subjects are on the same treatment arm, and is therefore partially unblinded.

 

Determine Shipment Method

You need to consider your method of shipping the drug to the patients. Do you want the depot to ship directly to the patients? Will the shipments be directed through an intermediary such as a central pharmacy or through clinical sites?

 

Define Material and Patient Logistics

Some logistical questions and considerations to keep in mind:

Virtual vs. hybrid

Will all the drug dispensing visits be virtual? Or will you use a hybrid model whereby the patient comes to the site for some visits and not for others?

Shipment triggering

Will the direct-to-patient shipments be triggered by the sites manually? Or will they be triggered automatically?

Opt-in/out

At what levels will groups in the studies be able to opt in and out of a direct-to-patient model? Will countries be able to do this? Will sites be able to do this? Will individual subjects be able to opt in or out? And if so, will this be happening again and again throughout the study?

Drug Returns/accountability

How will you manage drug returns and accountability in a more complicated model where the drug is with the patient instead of at the site?

Vendor capabilities

What are the capabilities of your IRT and distribution partners in the trial? This is very important to consider when aiming for a smooth execution of a DtP trial.

 

Select the Right Depot Provider

When looking at a depot vendor, you want to make sure this distribution partner is able to support the shipping models that you’re looking for in each region and country that the study will include. This accounts for any geographical variations in regulations based on countries and regions.

It’s also important to understand how much lead time the depot vendor will need to gear up for a direct-to-patient trial because this process requires more effort on their part.

Lastly, is the depot vendor able to handle the more complicated workflows and integrations that are necessary to execute a successful direct-to-patient model? Are they capable of handling a lot more shipments to a lot more addresses?

 

Select the Right IRT Provider

In closing, make sure your IRT vendor understands the challenges of a direct-to-patient model, has the experience and technical capability to recommend solutions, and the robust software necessary to implement the solutions that they are recommending.

You want to choose an IRT partner who has experience with DtP models that can help you understand how the decisions that you’re making will impact the material and patient logistics of the trial as well as help you manage the risks and complexities associated with that model. Some examples of complexities include:

  • Managing unblinding scenarios with patient-specific shipment cancellations.
  • Supporting multiple direct-to-patient shipping models within a single study.
  • Triggering of shipments automatically by the IRT system or manually by the site users, and having the flexibility to do both.
  • Allowing for hybrid visit schedules and the conversion of virtual visits to onsite visits and vice versa over the life of the study.
  • Understanding the impacts to site inventory projection buffers based on how these visit schedules may change over time.

Overall, you want an IRT partner that can manage the complex workflows and processes in a DtP model and effectively anticipate and mitigate the risks that are involved.

 

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Takeaway

These are by no means an exhaustive list of considerations when thinking about setting up a direct-to-patient trial. But they will at least help you understand various nuances when approaching such a complex, multifaceted model. And with the right tools, teams, and resources in place, the risks and complexities of a direct-to-patient model can be more easily mitigated. This allows trial teams and sponsors to focus on good clinical practice and recruitment in an increasingly patient-centric clinical trial landscape.

 

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