Novartis Launches ResearchKit Study for MS

Following in the footsteps of GlaxoSmithKline’s rheumatoid arthritis study, another pharmaceutical company is hoping to leverage Apple’s ResearchKit platform for clinical insights, this time on multiple sclerosis (MS).

The Novartis study, dubbed Evaluation of Evidence from Smart Phone Sensors and Patient-Reported Outcomes in Participants with Multiple Sclerosis or elevateMS for short, is intended to help researchers conduct a data-based study of the everyday machinations and effects of multiple sclerosis (MS).

The study will feature a downloadable mobile app, available in the App Store, that will collect patient questionnaire responses, passive and active sensor-based movement data, and performance tasks completed by patients.

Advocates, neurologists and patients were gauged on the app’s interface, utility and intent prior to its release. In an email, Novartis said that the intent of a mobile research study is to develop new patient-centric clinical research endpoints — differing from conventional testing of MS symptom burdens.

“These assessments can feel unrelatable when viewed from most patients’ perspectives,” the company said. “We need to get better at measuring the things that really matter to patients, like how well they can function physically and cognitively during their everyday lives, outside of the clinic.”

The app and study collection is available to both MS patients and non-patients, and participants have the right to leave the study anytime they would like. Though a major focus of the study is to analyze how treatments and medication are affecting actual patients in their daily lives, there’s still importance for civilian input.

“We are hoping that several thousand MS patients participate,” the company said. “We also need people without MS to participate — all of the data helps us. Based on other experiences with the Apple ResearchKit platform, we expect about one-third of the participants to be MS patients.”

Such real-time MS tracking via app has been planned by Novartis for over a year, but the desire to research the day-to-day effects of a neurological condition has been long-held.

“As physicians, we always want to know how our patients with MS are doing on the treatments we prescribe,” Stanley Cohan, MD, PhD, medical director of Providence Multiple Sclerosis Center, Portland, Oregon, said in a statement. “With the elevateMS app, study participants can frequently document their symptoms in a personal health story.”

The company says that user privacy is ensured, as every participant’s data will be delivered under an anonymous, random code.

ResearchKit has been a mixed bag for Apple so far. Released to fanfare, the potential of a mobile research platform is inherent, but interest decay and Apple exclusivity have proved hindrances. The demographics of iPhone ownership often do not represent disease prevalence: while iPhone owners are predominantly white, a 2013 Neurology study found the incidence of MS higher in black patients.

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