As our industry seeks out new approaches for treatment options, digital therapeutics (DTx) present a promising and growing sector for both patients and providers. Digital therapeutics offer modern solutions for evidence-based therapeutic interventions, helping patients manage, treat, or even prevent certain disease states or conditions.
Through powerful data computations, these products provide a level of understanding that is unmatched by traditional therapeutics. Their ability to be used in tandem with other devices and medications allows for a fully functional range of care.
We spoke with our PRA experts about the challenges and innovations that DTx bring to the clinical trial space.
This article was written in collaboration with the following PRA experts:
- Scott Schliebner, Senior Vice President, Scientific Affairs and Digital Therapeutics Lead
- Maria Harrison, Vice President, Real World Solutions
- Robert Bauer, Director of Operations, Real World Solutions
Challenges of running a digital therapeutics clinical trial
Digital therapeutics are new and different. We’re moving away from evaluating a traditional drug or a physical medical device, and instead evaluating software as a medical device or as a therapeutic. This shift changes everything about the way we need to approach a clinical trial. We’re not dealing with a chemical or biologic investigational product. We’re moving into a space that’s novel—not only for regulators and sponsors, but for payers and their willingness to reimburse.
The challenge, right off-the-bat, isn’t even about the protocol design of the study. It’s about answering broader foundational questions such as the following:
How are we going to put this new therapeutic in patients’ hands?
How do we educate some of the stakeholders about this new concept?
How will this intervention be used by patients in a real world setting?
We’re like pioneers, heading into a space where nothing has been clearly defined. This really is a new frontier.
Regulatory guidance also poses a challenge in DTx trials. We’re not evaluating a drug, but a software solution or an app that we’ve put in the hands of a patient. This research method is not as clearly defined from a regulatory perspective. We’ll need to work with regulators to understand realistic endpoints and assessments for a DTx trial. We’re seeing sponsors do the right thing—they’re seeking early consultation with regulatory bodies and staying engaged with them throughout a DTx trial, as this is new territory for all of us.
Proving the efficacy of a given digital therapeutic is another challenge. How patients act and use technology in a DTx study is different than how they would interact with a traditional therapeutic in a controlled clinical study. Until now, we’ve never truly had insight into what happens once a patient leaves a clinic. Since these studies take place in a patient’s daily life, in their own environment, we must figure out how to manage these new conditions and the real-word data we receive from digital therapeutics trials. We don’t have the same level of control that we do at a site level.
Clinical evaluation of digital therapeutics
Evaluating a digital therapeutic is dependent on the way in which it will ultimately be used, and DTx have a wide range of applications.
For example, we’ve spoken with sponsors that have an interactive “chatbot” app. The app provides a therapeutic intervention that serves a role resembling a counselor, available to patients as needed. We’ve also spoken with clients on the other end of the spectrum that have AI-guided software. This software can complete tasks like making scans more readable and more efficient in detecting something like early cancerous lesions.
Understanding the focus of a DTx product is essential to evaluating it in a clinical setting. Again, we need to ask ourselves broad questions, such as:
Is the goal to generate data to support claims of risk and efficacy and the intended use?
Are we trying to generate clinical evidence?
Are we just trying to make people aware of it so patients can use it?
How will this therapeutic be evaluated compared to the current standard of care?
If a client or a sponsor wants to take this process a step further and make claims around efficacy for their product, that changes how we’re going to clinically evaluate it and takes us down a more rigorous clinical trial path.
Differences between digital and traditional therapeutics
In terms of ongoing analysis and application of real-world evidence and product performance data, the primary difference between a traditional therapeutic and a digital therapeutic is that the latter provides information on usage and interaction in real-time. This ensures continued safety and effectiveness.
In a traditional trial, a doctor provides medication, the patient picks it up, and then we don’t know exactly what happens next. We only have anecdotal feedback from the patient to understand if they’re taking this medication as prescribed, if they’re taking it at the right time, if they’re taking it with or without food as directed, and so on.
Digital therapeutics have a feedback mechanism that can provide that precise information in real-time. As opposed to a traditional therapeutic, we’re dealing with software. This enables us with the profound ability to generate real-world evidence and insights, and truly understand how people are using this therapeutic in their everyday lives. DTx will continue to evolve over time, considering that we’re not manufacturing a pill or a drug, but rather leveraging a software that is, in a lot of ways, a living, breathing thing.
As a digital therapeutic is approved, it’s not necessarily going to stay in a “fixed state”, as would a traditional therapeutic. These feedback mechanisms – providing real-world evidence in real-time – can help us understand how patients are using a given therapeutic and what’s most effective for them. These insights can guide the evolution of a DTx to be more effective and engaging for patients as “version 1.1” becomes “version 1.2”. The challenge associated with this evolution is evaluating whether you need to run another clinical study for “version 1.3”.
Our digital health solutions are built with each specific trial in mind. Depending on the disease state, the patient population, and our sponsor’s targets, our experts will help determine the best approach to your particular trial. From enrollment and ongoing engagement efforts to consultations and in-depth analysis, we have the tools needed to conduct your DTx trial from start to finish.
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