Brad Hightower, CEO, Hightower Clinical
Craig Mooney, VP, Scientific eTech-Enabled Services, Calyx
In an earlier blog, we addressed the questions sponsors should ask before embarking on a Direct to Patient (DtP) drug shipment strategy as a component of decentralized clinical trials (DCTs).
Here, Craig Mooney interviews Brad Hightower to understand the investigative site’s perspective on implementing a DtP approach to clinical trial supply shipping.
Craig: What is a site’s perspective on IRT, in general?
Brad: At the site level, IRT is one of the most overlooked aspects of a trial, and that’s a good thing (compared to other solutions like eCOA, EDC, etc. that can cause pain points). I press a button, it gives me numbers, then I grab the assigned drug. I don’t know what’s happening in the background that makes it work.
Craig: That’s the idea with IRT – to make it as easy in / easy out for the site as possible. It’s easy to over engineer and I think sites want simplicity. Building on this, what do you think that looks like for DtP shipping?
Brad: It depends on several factors. For example, will patients now be expected to bear some of the burden that sites normally incur, in terms of IMP accountability, logging shipments and temperatures, etc.? If so, that’s not a patient benefit. If we keep the same paradigm, but just change the method in which we do it, it’s not necessarily a win for anybody.
Understandably, a DtP approach might sometimes eliminate an investigative site trip for a patient, but ultimately, how much is that moving the needle in terms of trial efficiency, subject retention, or drug adherence? I don’t know that those things are clear yet. Personally, I don’t know that I see a great advantage.
“If sponsors and IRT vendors keep having conversations about DtP with sites, we’ll see evolution at a much quicker pace.”
– Brad Hightower, CEO Hightower Clinical
Craig: In one decentralized approach, sites would need to become logistics organizations to get product to patients. Did you notice this during COVID? How much expertise did the sites in your network have with shipping to patients?
Brad: Depending on the site model, the logistics can be easy or difficult. But it’s important to consider the landscape of sites right now. In a lot of ways, we’re moving away from huge institutional sites toward more community partnerships, smaller networks that can reach underserved areas. A lot of these places won’t necessarily have the built-in infrastructure to manage logistics.
Also, there’s some wariness from sites regarding who’s responsible if something goes awry. We all know shipments get delayed, delivered incorrectly, or even stolen from porches. When that occurs, who bears the responsibility? These are the kinds of things that must be considered.
Craig: Another approach is where a courier delivers study medication directly to patients. Have you seen this in practice?
Brad: I’ve not seen that personally. But obviously a third-party courier approach raises other questions regarding PI oversight. In this scenario, it’s completely out of our hands because we never touch the drug and can’t ensure that the patient receives the right package. Sites get anxious when things shift away from our control. And we all want to help increase access to get more patients involved, but where’s the middle ground?
Craig: You mentioned the possibility of fewer site visits. Do you think that really is a benefit to most patients?
Brad: I think some patients appreciate not having to lose half a day to come into a site, sometimes just for drug. But I think a lot of patients like coming to the site and that shouldn’t necessarily be overlooked.
Craig: Agreed. If we’re running DCTs to be more patient-centric and to expand access to more patients, then we need to be flexible to meet the individual patient’s wants for each visit. And the IRT system would need to accommodate that type of flexibility. Do you agree?
Brad: I think that’s probably the ideal, but it depends on the study design. If the patient is only coming in for IMP (no blood draw or physical exam needed), then yes, let’s shift that visit away from the site. I’m just not confident that there are systems that can account for this level of flexibility today.
“If we’re running DCTs to be more patient-centric, we need to be flexible to meet the patient’s wants for each visit.”
– Craig Mooney, VP, Scientific eTech-Enabled Services, Calyx
Craig: Let’s turn to data protection. Consider the model where the order from the IRT to the depot is patient-specific and to be sent directly to their home. They receive the order, package it, and arrange the delivery. In this situation, third parties now have access to PII they haven’t had in the past. How will patients feel about their PII being given to another organization?
Brad: I’d say that while some are worried, others might not be concerned. We cover a lot of this throughout the consent process and there are questions like where is my data going? Who’s going to know I’m in this trial? Those are legitimate questions that must be addressed to remove patient concerns.
And when you’re talking about their medical data it could get very uncomfortable. That is certainly a legitimate concern that could turn patients against the DtP option or even the trial all together.
Craig: What are your thoughts on the use of RV/mobile units for site visits, especially for delivery of investigational drug?
Brad: I love the idea if the model shifts toward sites offering this, as opposed to a third-party provider. That way, it’s my staff, the same staff the PI and the patient knows. And in that case, I think it makes perfect sense for investigational drug delivery to be a part of that offering. Although, in fairness, not every site is going to be able to do this.
Craig: What is the biggest challenge in this space?
Brad: The biggest limitation with DtP and decentralized trials in general is that we lose some touch points with the patients. Coordinators appreciate having multiple interactions because that’s what keeps patients engaged and compliant, whether that be filling out a diary or taking their medication every day.
Craig: Any final advice on the subject?
Brad: I encourage sponsors and vendors to talk to sites, not make assumptions about what they want or how they operate. And I’d suggest educating sites about how the IRT works, because it’s not always clear to us. Keep having those conversations and I think we’ll start to see evolution at a much quicker pace.