Integration—or connectivity—between the DTx and a DCT platform is an effective avenue for gathering the data that sponsors need when they need it while also making the experience easier for patients. But, integration isn’t one size fits all.
So, what are the options for integration, and is integration with DCT platforms always necessary for DTx clinical trials?
We’re breaking down the three main approaches to integration so you can find the right fit for your clinical trial.
In a trial with no integration, participants use a DTx that isn’t connected with a DCT platform. They operate the digital therapeutic, then use a separate app (such as the ObvioHealth app) to report DTx use and their outcomes to the study team. For instance, with a point-in-time device like a blood pressure cuff, the patient would take a reading using the device and then report that data manually by inputting it into the DCT app.
In deep linking, a decentralized trial mobile app links to the DTx software. When opening the clinical trial app, the patient can be directed to the DTx, often without their recognizing the transition. As the patient interacts with the digital therapeutic, clinical trial data is captured. This approach requires the patient to operate only one app, thereby reducing their burden.
One caveat: If the study protocol requires patients to use the digital therapeutic as a condition of participation, this approach does not measure their propensity for “self-use” (The clinical trial app is prompting the patient to use the digital therapeutic, which means the act isn’t natural or self-determined.). This can be an important criterion for regulatory approval. If sponsors are seeking regulatory approval, it’s important to begin conversations with regulators from the outset to ensure the study design meets the expectations of government agencies.
With back-end integration, the information from the sponsor’s software feeds directly into the study team’s electronic data capture (EDC) platform. The two connect on the back end through an API, creating a direct line between the DTx and the study team. In other words, as a patient interacts with the digital therapeutic, the data from the device flows directly to the study team where it can be monitored in real time. For clinical trial questionnaires, such as ePRO, a clinical trial app would be used separately.
When navigating a booming market that is expected to reach a $2.5 billion value by 2030, differentiation is key, and that differentiation comes in the form of clinical trial validation. Finding the right DCT partner to design an optimal study is the first step. Working with them to decide which method of integration is the right fit is next.
There is no “one size fits all” method for integration. Choosing the right fit requires a holistic deep dive into your unique study goals and requirements—the therapeutic purpose of your DTx, your budget, your timeframe, and a myriad of other factors.