There is an ongoing digital shift in clinical trials, and as a result, companies are continuously striving to improve both patient experience and clinical data quality.
The 21st Century Cures Act which became law in the US in December 2016, paved the way for companies to develop new technology that is capable of improving the treatment of serious diseases with unmet medical needs.
Using digital instruments, artificial intelligence (AI) and machine learning, their API provides DTx sponsors with what they coin a ‘plug and play’ integration to its ObvioGo platform.
The company says it ensures by using tight integration the platform can capture more objective adherence and efficacy data and reduce the burden for clinical trial participants.
The integration reduces participant task duplication because, ObvioHealth says, in most cases, outcomes can be passively captured directly from the DTx.
“Adherence in a DTx trial isn’t as simple as recording whether a participant took a pill or didn’t. Instead, you need to capture the level of interaction between the participant and the DTx,” said Craig Gravina, chief technology officer at ObvioHealth.
“This requires data to be captured directly from the source—the DTx itself—without prompts that might influence the participant’s behavior.”
The challenges still facing DTx clinical trials center around measuring adherence and efficacy. To determine adherence, ObvioHealth said sponsors must consider the duration and frequency of DTx use and compliance with the DTx tasks.
Some clinical trials measure these factors through patient-reported questionnaires, but this method can bias the data due to the accuracy of declared behaviors whereby the questionnaires can trigger a participant to use the DTx to influence their real-world behavior.
Ivan Jarry, ObvioHealth’s CEO, said: “Some trial partners will use separate apps to ask many of the same questions that are asked within the DTx— an annoyance for participants and an overly complicated trial design for sponsors.
“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. “Our solution is uniquely positioned to overcome these DTx challenges and facilitate regulatory approvals.”
ObvioHealth’s mobile app can be used for complementary tasks, such as eConsent, screening, concomitant medication recording, televisits and the reporting of potential adverse events, in addition to other non-redundant eCOA data capture. The company is currently in the design phase for four DTx studies.
