New API Designed to Make Trial Data Collection Seamless for Prescription Digital Therapeutics

As digital therapeutics become integrated into the modern healthcare landscape, they are sparking change not only in the way therapies are delivered, but also in the way clinical trials are conducted.

However, that shift presents its own challenges, as developers seek ways to ensure their trials are scientifically robust without being overly burdensome to trial participants.

ObvioHealth, a contract research firm focused on decentralized virtual clinical trials, last month launched a new application programming interface (API) designed specifically for digital therapeutic clinical trials. The API is designed to seamlessly integrate ObvioHealth’s “next-generation” decentralized clinical trial platform, ObvioGo, into digital therapeutic applications.

Craig Gravina, ObvioHealth's chief technology officer, says the FDA has accepted data generated by innovative trial designs such as those used by many prescription digital therapeutic developers provided ALCOA data integrity trials were followed.

Craig Gravina, ObvioHealth’s chief technology officer, noted in a press release that trials of digital therapies have unique complexities that can affect the usefulness of the data received from the trial. For instance, unlike in trials of traditional medications, measuring adherence in a digital therapeutics trial requires measuring factors like the duration and frequency of the patient’s use of the product, as well as the patient’s adherence to prompts from the application.

“Adherence in a digital therapeutics trial isn’t as simple as recording whether a participant took a pill or didn’t,” he said. “Instead, you need to capture the level of interaction between the participant and the digital therapeutic. This requires data to be captured directly from the source — the digital therapeutic itself —without prompts that might influence the participant’s behavior.”

That last part is important, he said, because digital therapeutic trials carry the risk of biased data due to patients inaccurately reporting their behavior, or because a prompt to answer trial-related questionnaires might itself remind a patient to use the application when they otherwise might forget to.

The new API is designed to link the digital therapeutic with the ObvioGo platform in a way that actively captures usage and efficacy data without burdening patients. The company said in many cases ObvioGo can passively capture necessary outcomes data directly from the digital therapeutic, eliminating a layer of redundancy.

“Some trial partners will use separate apps to ask many of the same questions that are asked within the digital therapeutic,an annoyance for participants and an overly complicated trial design for sponsors,” explained Ivan Jarry, ObvioHealth’s CEO. “It’s important for sponsors to recognize these study design nuances that can have a dramatic impact on the integrity of study data and participant behavior.”

That data is especially important for prescription digital therapeutics (PDT) as they seek regulatory approval and to make it onto insurer’s formularies.

In an email to Managed Healthcare Executive, Gravina said the FDA has generally been “quite accepting” of clinical trial data generated by innovative trial designs like those used by many PDT developers, provided those trials abide by the agency’s ALCOA data integrity principles.

He said the FDA’s recently issued draft guidance explicitly allows for the use of digital health technologies (DHTs) to administer electronic clinical outcome assessments.

“The key is to ensure that the DHT is fit for purpose for remote data collection— which means it needs to be verified and validated,” he said.

Though the company’s API is designed to eliminate as much friction as possible, the company said its ObvioGo app can also be used by companies running clinical trials to perform complementary tasks like obtaining eConsent, screening participants, recording medications and adverse events, or conducting telehealth visits.

The company said it is currently in the design phase for four digital therapeutic studies.