Virtual clinical trials will be standard, says THREAD exec on Novartis project

By Brittany Farb Gruber

- Last updated on GMT

(Image: Getty/oatawa)
(Image: Getty/oatawa)
Novartis’ recently launched FocalView app will be used in a new study to remotely collect electronic device reported outcome measurements (eDROs) from 150,000 users.

Last month, Novartis announced​ the development of the new app that aims to allow researchers to track ophthalmic disease progression by collecting patients’ real-time data.

Scientists from Novartis partnered with THREAD to engineer the ophthalmic digital research technology. FocalView aims to provide researchers with a greater volume of real-world, device-reported and patient-reported data resulting in creating more flexible and accessible clinical research designs.

“These eDROs represent an advancing form of digital endpoint data collection combining patient training, phone supported tasks and sensors into one, patient-facing activity,” ​John Reites, chief product officer, told Outsourcing-Pharma.

“The visual acuity and contract sensitivity tests are enabling patients to contribute new data in clinical trials at home,” ​he added.

The app also includes the use of electronic consent (eConsent), electronic patient reported outcomes (ePRO), surveys, and other digital trial elements.

Plans for study

Once 150,000 people have downloaded the app, FocalView will initially be tested in a prospective, non-interventional study lasting 12 months, to evaluate its efficacy and usability in assessing visual function. Plans for the next phase include validating it against traditional visual testing that takes place within conventional clinical settings and will depend in part on the outcomes from the first.

“Our initial focus will be on assessing FocalView’s efficacy and usability,” ​Dirk Sauer, development head for Novartis’ opthalmology unit. “By adapting the design of trials to suit the daily routine of patients, we hope to reduce barriers to participation, removing the challenges faced by patients with visual impairment in attending fixed appointments, to make clinical trials more efficient, affordable and patient-friendly.”

“Some studies utilize fully virtual trial methods whereas other studies use a lighter set of remote research approaches,”​ added Reites. "We see the future of virtual trials as a standard approach for the patients, sites, sponsors, and CROs​.”

The platform enables patient engagement, remote data collection, and helps replace on-site visits with virtual visits for various therapeutic areas, patient populations, and endpoints, he explained.

Long-term goals

Currently, FocalView is only available for download on the App Store in the US. However, Sauer told us that Novartis intends is to make the app more widely available, both on non-iOS devices and in additional countries and languages. Specific markets have not yet been agreed upon.

Additionally, Sauer said he hopes FocalView ultimately diminishes the barriers to participation. Novartis’ strategic alliance​ with Science 37 is helping the company edge closer to its goals closer to the launch of a “site-less” model for clinical trials that will improve both patient accessibility and quality/quantity of data.

“By adapting the design of trials to suit the daily routine of patients, we hope to reduce barriers to participation, removing the challenges faced by patients with visual impairment in attending fixed appointments, to make clinical trials more efficient, affordable and patient-friendly,”​ he said. 

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