Swiss-based company, Novartis, has launched a digital research platform created with Apple ResearchKit — FocalView app — which it hopes will modernise ophthalmic clinical trials making them more accessible and flexible.
digital eye
The app has been designed to enable researchers to track disease progression by collecting real-time, self-reported data directly from consenting adult patients. As in this format it may be more suited to a patient’s daily routine, the app could lead to a reduction in the number of barriers to patient participation in clinical trials. Moreover, if more patients participate in trials a more detailed understanding of ophthalmic diseases should be possible which could lead to faster development of novel treatments.
In traditional ophthalmic clinical trials data capture can be inflexible and infrequent, making it difficult for researchers to monitor disease activity and capture real-world experiences, in addition to making it inconvenient to the participant. With the FocalView app, it is hoped that patients will be able to complete various assessments themselves, gaining feedback on their visual function inclusive of any changes over time.
“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,” explained 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 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.
“Optimising 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, Novartischief 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.”
FocalView is now available for download from the App Store in the US. Consent to contribute to research data will be required before a user can interact with the tool. Novartis is planning to launch in additional markets in the future.