Novartis Joins Innovative Solution Trend for Clinical Trials: Launches FocalView App

The biopharma industry is starting to leverage mobile apps and other digital technologies to improve access to clinical trials. Novartis launched FocalView, an app for ophthalmic patients involved in eye-related clinical trials.

"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 Mark Bullimore, medical advisor for the creation of the app and dean of the Southern California College of Optometry at Marshall B. Ketchum University, 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 app is now available for download from the App Store in the U.S. It’s designed to allow patients to complete specific assessments, get feedback on their visual function, and provide scientists with more real-world, patient-reported data.

FocalView will be tested in a prospective, non-interventional study to determine its efficacy and usability. The measurements will include visual acuity and contrast sensitivity, as well as ease of use, level of enrollment and ability to obtain important documentation for future trial research.

"Optimizing 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,Novartis’ chief digital officer, in a statement. "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."

This is just one example of efforts made by companies, entrepreneurs and the government to improve clinical trials. The U.S. Food and Drug Administration (FDA) is pushing to cut clinical trial times and improve access for the terminally ill to experimental medications. It’s been noted that contract research organizations (CROs) have been investing in technology that includes clinical trial data management systems.

Vivek Ramaswamy launched yet another biotech company in September 2017 called Datavant,which will use artificial intelligence (AI) to improve clinical trials. At that time, Datavant had gathered data from 85 different datasets made up of over 20 million patient visits. The company plans to analyze and collate the data using AI with the intention of informing the design and operations of clinical trials.

In April, Pfizer joined the TriNetX global health research network, which allows the company to access clinical data from the network’s healthcare organizations. TriNetX, based in Cambridge, Massachusetts, connects healthcare organizations, biopharma companies and CROs in order to collaborate and share data, with the goal of improving clinical trial design, making it faster and easier to recruit patients to trials, and accelerate the clinical trial process.

And it shouldn’t be underestimated the amount of data that companies like 23andMe, Helix and Ancestry.com are generating with their consumer-based DNA tests that are then sold to biopharma companies to be used in support of drug development and clinical trials. One small startup, Nebula Genomics, has devised a scheme using blockchain and its own internal cryptocurrency to allow patients to "own" their genetic data, which can then be sold via Nebula, to biopharma companies. Other companies, such as Luna DNA, EncrypGen and Zenome are developing similar platforms.

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