Remote Digital Biomarker Monitoring Bringing a smartphonebased diagnostic test for Parkinson's Disease progression into an interventional trial

In clinical research objective, automated and high frequency measures of diseaseprogression are hard to come by. Traditional physicianledtests are only done periodically, missing the fluctuations of disease activity that strongly affect patient's quality of life. They also lack the objectivity that is so important when developing medicines. By providing patients with mobile sensors they carry day in and day out to conduct tests andcapture the data, we are addressing this need. We designed a custom Android App asking patients to complete six “Active Tests” on adaily basis, wherever they are. After completing the Active Tests, patients will then poptheir phone in their pockets and carry it around with them throughout the day. This is whatwe call “Passive Monitoring”. We have established an end to end approach and technology platform with greatpotential. Our experience will give other clinical studies the confidence that we can bringthe required software and workflows to the clinic. Compliance and ethics hurdles havebeen cleared and investigators trained. We are already gaining experience with patientuptake and are developing the necessary data analysis techniques. Interpretation ofmobile sensor data might soon replace traditional assessments.