Novartis launches app for remote participation in clinical trials

A new smartphone app lets patients participate in ophthalmology trials without stepping foot in a clinic. Novartis’ FocalView app guides patients through self-assessments of visual function and disease activity, streaming large volumes of real-world data directly into researchers’ hands.

The app, created using Apple’s ResearchKit platform, aims to dissolve barriers to patient participation by easing the enrollment process, improving compliance and reducing the time and expense of clinical exams. Data capture in traditional ophthalmic clinical trials tends to be “inflexible and infrequent,” Novartis says, so adapting a trial’s design to fit the daily routine of patients could spur participation.

If proven effective, FocalView could help uncover key insights about disease manifestation or progression by providing researchers with real-time reports collected over a span of months or years.

“Optimizing digital technology in research and development, particularly in ophthalmic disease, could have a marked impact on the quality of the data we capture,” said Bertrand Bodson, chief digital officer at Novartis. “We believe apps like FocalView, which we've made freely available to the research community on an open-source platform, can help accelerate the development of treatments and bring them to the patients who need them most.”

Researchers will soon take the app for a test run in a prospective, non-interventional trial to determine how well it captures visual acuity and contrast sensitivity compared with traditional assessments in a clinical setting. During the study, scientists will rate the app’s ease of use, track enrollment numbers and report any challenges related to gathering documentation, such as informed consent, from participants.

FocalView is available for download from the App Store in the US and will be offered in additional markets in the future, Novartis says.