Novartis has launched its FocalView app, an ophthalmic digital research platform created with ResearchKit 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, making it difficult for researchers to monitor patients’ disease activity and capture real-world patient experiences. FocalView aims to help patients complete various assessments, gaining feedback on their visual function, 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. “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.”
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 enrollment 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.
