Novartis has launched its FocalView app, an ophthalmic digital research platform created with Apple’s ResearchKit.
The app aims to allow researchers to track disease progression by collecting real-time, self-reported data directly from consenting patients. By adapting the design of clinical trials to suit the daily routine of patients, the app may reduce barriers to participation, leading to a more nuanced understanding of ophthalmic diseases and potentially accelerating the development of novel treatments.
Data capture in traditional ophthalmic clinical trials can be inflexible and infrequent, leading to increased difficulties for researchers to monitor patients' disease activity and capture real-world patient experiences. The app will therefore aim to support patients complete various assessments, gain vital feedback on their visual functions, including any changes over time. At the same time, the app could provide researchers with a greater volume of real-world, patient-reported data, creating more flexible and accessible clinical trial designs.
"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," said Dr. Mark Bullimore, Medical Advisor for the creation of FocalView and Dean of the Southern California College of Optometry, Marshall B. Ketchum University.
"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."
FocalView will be tested in a prospective, non-interventional study to evaluate the app's efficacy and usability in assessing visual function. These measurements include visual acuity and contrast sensitivity. Researchers will in turn assess ease of use, level of enrolment and the ability to obtain important documentation for future clinical trial research, such as informed consent.
In the next phase, the app will be validated against traditional visual testing that takes place within conventional clinical settings.
"Optimizing digital technology in research and development, particularly in ophthalmic disease, could have a marked impact on the quality of the data we capture," commented Bertrand Bodson, Novartis Chief Digital Officer.
"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."
The move follows on from its $8.7bn acquisition of AveXis Inc to become a key player within gene therapy and support its ambition to become a leader in neurodegenerative diseases.