When weighed against an onsite trial, a decentralized study offers a number of benefits, for researchers and patients alike. However, some of those appealing aspects—such as enabling the participants to remain in the comfort of their homes—can also lead to challenges (for example, planning to get trial meds and supplies to and from those homes).
Ariette van Strien, president of Marken, spoke with Outsourcing-Pharma on how planning a decentralized trial differs from onsite in terms of logistics, and what factors need to be weighed in order to maximize chances of success (and avoid snags).
OSP: Could you please share some of the key ways in which a strategy for a new onsite trial differs from that for a decentralized/virtual trial?
AVS: The logistics strategy for any clinical trial is largely underestimated. When considering a decentralized trial, you need to look at the entire protocol design differently. The protocol is set up in a different way because you need to consider which visits can be done virtually depending on the clinical and biological assessments that need to be completed.
There are some significant advantages to decentralized trials. First, you do not need the same number of investigator sites as with a brick-and-mortar trial. That is an interesting differentiator. If you move to decentralized trials, you can go much larger from a geographical perspective because the travel will be reduced for the hybrid approach or avoided almost entirely for virtual trials.
Another key differentiator is how do you attract patients to your trial? Typically, an investigator would look at their existing patient database, but with the decentralized model, you suddenly can go much more extensive and probably attract a whole other client or patient base than previous trials.
There should also be higher patient retention with decentralized trials because the inconvenience or disruption to the patient's life is more minor. However, you will work with other partners to include the telehealth visits, potentially adding costs to your trial.
Overall, I believe we will see more hybrid trials. We have seen a move towards the hybrid approach, and we're not going back. That said, while some want to stay with a purely decentralized trial, they do not accommodate every therapeutic indication. It's critical to understand that you always need to have the visits conducted in a hospital or clinic with some therapeutic indications.
OSP: What are some of the things a trial team needs to keep in mind when incorporating direct-to-patient services in a study?
AVS: One of the most important aspects of any direct-to-patient trial is understanding that the drug needs to be delivered and, in many cases, a nurse needs to be at the patient's home for drug administration, especially collecting vital signs early on. If you have one or two trials doing that, that's fine, but when you reach 20,000, 30,000, or 40,000 direct-to-patient deliveries and 40,000 nurse home visits per month, it's important to have an experienced logistics partner.
For example, consider a direct-to-patient trial in Latin America. You can have one site in Sao Palo, but you have your patient 4,000 miles away, at the other end of Brazil, and need to deliver the drug. I think that is vastly underestimated. Patients are not just in the suburbs of a main city. Trial teams have the advantage of including a much larger patient pool, but they need to consider what that means for the logistical challenges. We have seen many remote areas in these larger countries, and that's a big challenge Marken is solving.
Other logistical challenges of a direct-to-patient trial include coordination to avoid the nurse and driver being at the patient's home simultaneously. You have to precisely coordinate so you can deliver the drug to the patient's home. What do you do if there's a temperature excursion? What do you do if the nurse already did the blood draw, centrifuged it, and then left the samples with the patient until the driver picks them up? Can you deliver the drug and have a more straightforward way of looking at the temperature's integrity?
We're looking at all of that to continue to simplify the logistics, even to the point that our UPS drivers can pick up any box from any patient in the middle of the street because they have a QR code on the package, and it can be scanned. We're going really far in trying to find new solutions, but the logistics are often largely underestimated by trial teams.
OSP: Why is a clear line of communication with patients an important part of a logistics plan?
AVS: A clear line of communication starts with the investigator. If you want the patient engaged in these new trials, they need to understand what that means, who will deliver the drug, and who will pick up the samples. It's not the same anymore as when you're in a clinic at a hospital, and you have a nurse doing it all. It's vital that in the informed consent, it's already written who the provider will be and what they will do so that the patient feels at ease.
Communication between the doctor and patient is also critically important in any clinical trial, in any medical setting. The trust factor is a massive part of the outcome of the clinical trial. Patients also need to trust the logistics company chosen and understand that it is an extension of either the physician, the manufacturer, where the drug will be delivered, and that the nurse is as qualified as the one in the clinic. Creating this early trust is critical for patients not to drop out of a trial.
OSP: Similarly, what are some of the risks inherent in not properly planning for streamlined patient communications?
AVS: We saw it in some cases where, mainly in a pediatric trial, the parents were so nervous, they were watching every single step of what the driver and nurse were doing. That created a considerable stress situation for their child. When a person is sick and participating in a clinical trial, there is already a high stress level, so how you set it up can avoid a lot of incidences and critiques.
At the beginning of any clinical trial logistics plan, the best communication is the key to success. Without clear communication, patients don't feel as comfortable. In a hybrid or decentralized trial, that could result in the patient making mistakes, and they could get excluded from the trial because they weren't in compliance with the protocol design.
OSP: Could you please tell us about your Patient Communications Center (PCC) —what it is, how it works, key capabilities, and how it differentiates your company's logistics solutions package from other organizations?
AVS: Marken's Patient Communications Center is in three global locations: Philadelphia, US; Edinburgh, Scotland; and Ciudad de México, Mexico. We launched in Philadelphia because most of these direct-to-patient, decentralized or hybrid trials, started in the United States.
We now have this direct communication globally so we can support 14 different languages. Our Patient Communications Center explains to the patient where the driver is, what the driver will be delivering, the location of the nurses, and how each will communicate. If a patient has a question, shows any symptoms linked to their treatment, or feels insecure, they can call us, and we can direct their inquiry immediately back to their investigator site.
Having this open communication with the patients so that they feel that they can call and ask any question is critically important. Patients can trust us as an intermediary between themselves and the physician. Our Patient Communications Center is about caring for the patient along each step of the protocol.
OSP: What are Marken's plans for growing its logistics and patient communications capabilities?
AVS: We are brainstorming how we can further develop our Patient Communications Center. For example, as medical devices such as blood pressure monitors and spirometers become more widely used in virtual trials, we are exploring how we can provide assistance and answer any questions a patient may have. We want to expand our Patient Communications Center further to offer even closer support to a patient.
As hybrid and virtual trials continue to grow, Marken is committed to staying one step ahead. Not just logistically but also by providing caring support to each patient on their journey.