Is Direct-to-Patient (DtP) the Tip of the Virtual Trial Iceberg?
Over the last few months, we’ve seen hybrid trials becoming standard. More and more patients are receiving medications at their homes. This Direct-to-Patient (DtP) model of shipping the drug from the site to the patient or from the depot to the patient is also being used as a contingency plan. Without knowing how long COVID-19 will remain a disruption, we have to be proactive in coming up with a Plan B and Plan C. Being able to find each shipment, to know where the kits are and whether or not the patient received them is a core benefit of DtP functionality within a modern RTSM.
However, it is important to know as we look to the future, DtP is just the tip of the iceberg. It is the beginning of a bigger revolution in clinical trials towards virtual clinical trials. So what is the difference between DtP and Virtual Trials, and why is it such an important distinction? Below are key considerations as trial professionals develop different scenarios over the next 18 months.
1. DtP is a Critical Component of Virtual Trials
Direct-to-Patient (DtP) has been an innovation that was long time coming. It is step in the right direction towards patient centricity that was catapulted to fruition in the wake of the COVID-19 pandemic. In the context of Virtual Trials, an important distinction is that DtP is mostly Depot-to-Patient, instead of Site-to-Patient. If you look at DtP as the infrastructure to get the drug to the patient, a modern RTSM that enables Depot-to-Patient is the tool to ensure flexible execution and drug accountability. But, what happens after the drug reaches the patient?
2. Patient Voice is Gaining Momentum
What we see now is that patient voice is gaining much more momentum. They appreciate the convenience of receiving medications at their home and minimizing the number of visits to the clinical site. As a result, we must look at more virtual trial platforms, from various perspectives, and ask ourselves, how can we make it better?
3. The Site Experience Needs to Change
Clinical research sites are required to log into many different systems. While they are accustomed to the EDC, RTSM (among others), newer systems are in play as we move to virtual trials models. For example, eConsent platforms are being used to consent patients to receive drugs at home and to agree to participate in a clinical trial. Telehealth and e-diary platforms are used to conduct remote visits and monitor progress and adherence. When you take into consideration the sheer volume of systems they need to access every day, from managing the data to working with patients, they can be overwhelmed. How can we, collectively as an industry, make that better? While we don’t have the solution today, we are exploring the best ways to integrate systems to make the site experience much better – either by signing in one place to access all their systems or maybe to access all their actions in one place.
4. Patients are Moving from Passive Participation to Playing an Active Role
Today, patients are participating in a study, but in a very passive way. They are coming to the site, going through some tests and exams. Very often the physician administers the drug at the clinic. In the DtP model, or in Virtual Trials, they are requested to do much more. They are moving from a passive participant to a very active role where they need to know how to administer the drug. They need to get remote guidance, and understand the responsibility of storing the medication. Sometimes they need to go through exams virtually. In some cases, nurses can go to the patient’s home, but that is not always possible. Sometimes they have wearables that collects data automatically. In other cases, they also check their weight, report it and as well as log into different telehealth systems for video chats with their physician.
5. Where is the Line? What Does the Future Hold?
At what point does the convenience of being done virtually outweigh the burden to the patient for completing so many tasks? Where is the line where we say that this is not up to the patient to do, this is something that we must have the site staff do?
The answer may not be where that line resides, but how we make the entire process easier. Can we create an app that would integrate all those functionality and help patients? What other services are needed? Do we need to supply a fridge to the patient’s home so they have place to store the medication? Do we need to do more virtual visits? Or are physical visits needed to maintain the relationship? What kind of tools should we use? How do we do virtual monitoring? We also need to take some time to investigate risks. What can go wrong? Once we’ve identified those risks, there should be a plan B or C.
Back to what we discussed at the beginning. If we view DtP as a way of shipping the medication, it is one small (and critical) change in the way we are running clinical trials. We are expecting to see many more changes in the future and it looks like it is in the very near future. To support sites and patients through a true virtual platform, we must collaborate.
Amy Ripston, 4G Clinical Vice President of Marketing, has over 20 years of B2B experience, of which she spent 9 years in the bio/pharmaceutical industry. Amy has a knack for identifying market trends, synthesizing content, engaging thought leaders, and connecting businesses with innovative solutions.