Pharma giant Novartis is taking a digital approach to clinical trials to track the progression of ophthalmic disease through its new FocalView app.
The tech, which was created using Apple’s ResearchKit platform, allows researchers to track disease progression by collecting real-time, self-reported data directly from patients. Novartis hopes the app will spur more participation in clinical trials through its ease of use as well as generate a clearer view of ophthalmic diseases that could lead to the development of new treatments.
Patients will self-report data through the app by taking assessments like visual acuity and contrast sensitivity tests. Currently, data collected for trials mostly comes from clinics that is first gathered by physicians through interactions with patients.
"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," Mark Bullimore, M.D., an advisor for the creation of FocalView and dean of the Southern California College of Optometry, Marshall B. Ketchum University, said in a statement. "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."
The FocalView tech will be tested in a prospective, non-interventional study to evaluate its efficacy and usability in assessing visual function. The information will be used by researchers to assess ease of use, level of enrollment and the ability to obtain important documentation for future clinical trial research, such as informed consent. The second phase study will validate the app against traditional visual testing that is typically performed in conventional clinical settings.
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Novartis CEO Vas Narasimhan, M.D., has focused the company on building a digitally enabled pipeline. Since taking over as chief executive in February, the company initiated an $8.7 billion takeover of gene therapy biotech AveXis and is sketching out a vision for how technology will overhaul drug development.