Pharma, Health IT

Novartis re-imagines clinical studies for eye diseases with new app through Apple ResearchKit

One goal of FocalView is to create a more accurate way to track and measure disease progression and develop more sensitive clinical trial endpoints from the comfort of patients’ homes., adding more flexibility to clinical trial design.

As pharma companies work towards a vision of enabling clinical trials from the comfort and convenience of participants homes to improve clinical trial recruitment, Novartis has launched an app to achieve this for studies tied to ophthalmology in the U.S. market.

FocalView, an ophthalmic digital research app created with the open-source platform Apple ResearchKit, is designed to collect real-time, self-reported data directly from consenting patients, according to a news release.

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There are four components of the app designed to assess vision outlined in a blog entry on ResearchKit’s website:

  • Visual acuity and contrast sensitivity: Using the Landolt C eye test, the app aims to assess the user’s ability to identify the gap in the C at various sizes as well as contrast levels.
  • Steps outside the home: Designed to track the activity of a user, the app sets a home area and uses geo-fenced technology to track when they leave their home and how many steps they take. For those participating in the clinical trial, this activity is designed to identify potential links between the efficacy of the medicine and a participant’s confidence in leaving the home.
  • Mood survey and questionnaire: Weekly reminders to allow users to track their mood status, including “sad”, “somewhat sad”, “somewhat happy” and “happy”. A questionnaire (VFQ-25) also enables users to evaluate the impact of visual function on daily activities.
  • Adjusting to darkness: Measures the length of time required for the user’s eyes to adjust to darkness and identify an object.

One goal of FocalView is to create a more accurate way to track and measure disease progression and develop more sensitive clinical trial endpoints, according to the blog post. That could go some way towards standardizing how researchers use apps like this to collect relevant data, improve understanding of ophthalmic diseases, and speed up development of new treatments.

The FocalView app will be free for researchers to use but those study participants interested in downloading the app must first give informed consent for their data to be shared.

Although the hope is that FocalView can advance clinical research, the app itself will initially be tested to determine how effective it is at collecting data. It will be assessed for ease of use, level of enrollment and the ability to obtain documentation for future clinical trial research, such as informed consent. The app will also be validated in comparison with traditional visual testing in conventional clinical settings.

Although enabling clinical trials to be done remotely is regarded as a way to improve convenience to participants without the trials interrupting their professional and social lives, this approach also stands to make these trials accessible to a more diverse patient population, which has been a challenge long lamented by clinical researchers. Another advantage is that the participant’s regular environment is a better location than a clinical one, removing transportation barriers and providing a window into the patient’s experience. The overarching goal is to reduce the length of time for clinical trial recruitment which can be the most costly part of drug development, taking up to a year with some trials. Pivotal Financial Consulting’s rough estimate of the costs for patient clinical trial recruitment added up to $6.25 billion for 2013.

Janssen has also shown interest in making remote clinical trials possible with the development of the Integrated Smart Trial and Engagement Platform, or iSTEP, which includes a few different components. Connected medication blister packs note when each pill has been taken. Electronic drug labels make it easier to convey medication information in the participant’s language. Another component, eCommunication, makes it easier to customize information to individual trial participants. Videos and patient notifications can be conveyed via smartphone.

For patients with eye disease, who are often not mobile, this app stands to break down barriers for entry to clinical studies, according to Dr. Mark Bullimore, medical adviser for the creation of FocalView and Dean of the Southern California College of Optometry at Marshall B. Ketchum University in Fullerton, in the news release.

Although the U.S. will be the first market where the app is assessed, the plan is to expand the app’s availability to other countries.

 

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