Novartis has announced the launch of its app FocalView, an ophthalmic digital research platform designed to allow patient participation in clinical trials from home, improving accessibility and flexibility.
The app was created using the Apple ResearchKit and aims to allow researchers to monitor disease progression using real-time and self-recorded data from patients. Researchers hope that designing clinical trials around patients’ routines will boost participation numbers and lead to more accurate and detailed data, accelerating treatment development.
"Because patients with eye diseases are often not as mobile, FocalView has the potential to offer tremendous benefit for the ophthalmic community and for researchers looking to develop better treatments for these patients," FocalView medical advisor Dr. Mark Bullimore said.
"Collating validated patient-reported outcomes in clinical trial research is no longer a nice-to-have. This kind of data is fast becoming a critical element of research and development, because it offers a better reflection of real-world patient experiences, fosters better patient compliance and provides researchers with richer and more accurate data points."
Traditional ophthalmic trials are often inflexible and infrequent, leading to difficulties in collecting patient experiences and information on disease activity. FocalView seeks to remedy this through gathering patient data on disease progression and participants’ visual function, including any changes over time.
The app is due to be tested in a non-interventional study which will evaluate its efficacy and usability in assessing visual function, including visual acuity and contrast sensitivity. Additionally, ease of use, level of enrolment and ease of obtaining information for future trial research will be assessed. The app will also be analysed in comparison to traditional visual testing within conventional clinical settings.
"Optimising digital technology in research and development, particularly in ophthalmic disease, could have a marked impact on the quality of the data we capture," Novartis chief digital officer Bertrand Bodson said.
"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."
FocalView is currently available in the US for download on the App Store. Patient consent is required before they can use the app.
Streamlining the clinical trial process has long been a concern for researchers, with numerous logistical challenges presenting themselves in everything from trial participation to data collection. As such, using technology to enable off-site trials has been of central interest for a number of years.
ResearchKit, launched by Apple in 2015, is an open-source platform designed for the development of medical research apps. It can be used to create surveys, consent templates and can collect data using iPhone sensors.
Similar ventures include one by New York-based company Medidata, which offers cloud storage, management software and data analytics services for clinical trials, and another from Los Angeles-based Science 37 with its Network Oriented Research Assistant (NORA) platform which enables real-time video chat, electronic data collection and electronic consent.
Novartis is known for its work in developing treatments for eye disorders such as glaucoma, dry eye and a range of retina diseases. Approximately 200 million people around the globe were treated with Novartis ophthalmic products in 2016.