Enhancing Participation in Digital Therapeutics Clinical Trials with a Decentralized Model

Clinical Researcher—April 2024 (Volume 38, Issue 2)


Anthony Brogno




Since 2021, there has been an increase among the general public in willingness to participate in clinical research studies. However, participants want the trials to be more convenient, closer to home, and more accommodating of their schedules.

Those are among the findings of the 2023 Perceptions & Insights Study from the Center for Information and Study on Clinical Research Participation (CISCRP), which surveys clinical trial participants every two years to collect information on individual experiences during participation.

These findings are instructive for digital health companies and contract research organizations (CROs) which, by and large, are still modelling clinical trials for digital therapeutics (DTx) on those used for pharmaceutical and biotech studies. Switching to a decentralized clinical trial (DCT) model will encourage greater participation and result in more participants completing the trial. While DCTs can be used for many studies, they are particularly suited for DTx products since they are widely regarded as presenting low risk to participants, and such trials can operate under a less strict regulatory framework and be designed with a more patient-centric approach.


The pandemic proved that many more work- and health-related activities can be accomplished remotely more conveniently than we once thought possible, including accessing healthcare. People now guard their time more carefully, with staying at home often the preferred option for work, doctor appointments, shopping, entertainment, and more.

Bearing this out, the 2023 CISCRP survey of more than 4,500 individuals globally who have participated in a clinical study found that traveling to the clinic for procedures was the greatest burden for participation. Among those who quit trials before they were completed, the location of the study site was the second-most cited reason. Asked what would have encouraged them to complete their trials, 32% of respondents replied, “more virtual visits.”

Healthcare as a Commodity

None of this should come as a surprise to those who have noticed the growing trend toward the consumerization of healthcare. After decades of working around providers’ policies and schedules, patients are asserting themselves as consumers, treating healthcare like a commodity and prioritizing convenience above all. While trial participants are perhaps more magnanimous than the average patient, they, too, value their time and convenience.

Modern CROs have taken note of this and now offer hybrid or fully remote (decentralized) site capabilities for DTx sponsors to create real-word settings in which patients can carry out study activities. Much of the data collected from DTx technologies involve satisfaction measures such as emotional affect, user experience, and quality of life variables that can easily be captured without traveling to a brick-and-mortar facility. CROs are also using networks of travel nurses and study staff to perform physical assessments and collect bodily samples from participants’ homes to mitigate the need for in-clinic study visits.

Most clinical research participants today are also discovering opportunities to be in clinical trials online. CISCRP’s study reports that, of the individuals who learned about their studies online, 46% were made aware through social media channels and 26% through web advertising. DTx sponsors can ensure they are implementing a well-rounded digital marketing strategy by using a CRO that is experienced in acting as a DCT site to accelerate recruitment.

This model enables DTx sponsors to screen potential participants and allow them to participate in their trial regardless of geographic location, ultimately producing a more diverse patient population. These CROs are set up to attract the right participants through in-house clinical operations and marketing teams that screen for DTx patients who meet study inclusion/exclusion criteria and that run multi-channel recruitment campaigns.

Lastly, 86% of participants in the CISCRP survey reported they felt appreciated for their involvement in clinical studies. Even in virtual DTx trials, CROs in this space maintain excellent rapport with trial participants. Decentralized sites, although fully remote, are staffed with knowledgeable clinical research coordinators who act as the first point of contact for anything trial-related, from technical questions about the DTx technology being used to more pressing health concerns. At the end of the day, a trial is nothing without patients who are willing to participate and contribute.


Decentralized trials create an overall better experience for both sponsors and patients. Due to the nature of digital therapeutics technologies and their journey to market, there’s no reason most DTx sponsors can’t execute fully decentralized trials. When people have the autonomy to complete study activities and manage their healthcare in a real-world setting, they are happier and less likely to drop out before completion.

It’s time for DTx trial sponsors and CROs to modernize their operations and design trials to be as convenient as possible for participants.

Anthony Brogno is Director of Clinical Operations at Lindus Health.