The Lupus Research Alliance, the world’s largest private founder of lupus research, and Pfizer, the global biopharmaceutical company, announced the start of a non-interventional clinical study that will test a custom smartphone app enabling lupus patients to report on their fatigue and other symptoms in real time.

Incorporating feedback from people with lupus, the new app will be evaluated through a non-interventional clinical study called VALUE (VAlidation in Lupus of an Electronic Patient Reported Outcomes Tool), scheduled to begin at the end of this month. If successful, this new app will permit patients to use their smartphones to report on symptoms of lupus such as pain and fatigue. These reports are now obtained largely through paper surveys during visits to physicians’ offices.

Pfizer, the Lupus Research Alliance and Tata Consultancy Services Ltd. jointly developed the new mobile app, using the Apple ResearchKit platform and building on existing research tools that have been validated in lupus.

“This is an important step in demonstrating that mobile technology can improve how and what patients report to their care teams about subjective but serious symptoms of lupus, such as debilitating fatigue,” said Kenneth M. Farber, co-CEO and co-President of the Lupus Research Alliance. “This app may enable more frequent and consistent reporting from patients, thus providing better information for care teams and empowering patients to take a larger role in developing future therapies.”

Patients enrolled in VALUE will use an iPhone with the app installed, submitting self-assessments of symptoms over a two-month period. This data will be compared with standard questionnaire data collected by traditional methods such as written surveys in physicians’ offices. VALUE will help determine if information reported by patients through the new app is sufficiently complete and accurate to be used in future studies of new lupus therapies.

“The current paper methods of collecting patient-reported data can be cumbersome and inconvenient, and often depend on memory. VALUE holds promise for ‘in the moment’ reporting of symptoms and may open the door to similar tools being used in Pfizer-sponsored clinical studies for lupus and other diseases,” said Freda Lewis-Hall, MD, Pfizer Executive Vice President and Chief Medical Officer.

VALUE is being conducted through the Lupus Clinical Investigators Network (LuCIN), an alliance of independent investigators focusing on clinical trials for therapies that may be important to lupus patients. LuCIN was launched and is funded by the Lupus Research Alliance. VALUE is slated to launch this month, with results expected in December 2017.