How Wearable Devices and Digital Clinical Measures Can Improve Neurology Trials

Drug development in neurology is notoriously challenging. Despite being one of the most active areas of clinical development, neurological disease drug trials have among the longest development timelines and highest failure rates in the industry. This poor track record reflects the complexity of the nervous system and the lack of mechanistic understanding of neurobiology in humans. Imprecision in both disease diagnosis and symptom monitoring presents additional hurdles for clinical development.

Neurological diseases are inherently complex, manifesting a variety of motor and non-motor symptoms. This complexity, combined with slow progression and symptom fluctuation, impedes the accurate assessment of disability and disease progression. Traditional measures based on subjective rating, either by clinicians or patients, are susceptible to rater bias and are often sampled between long intervals of time. These clinical measures do not capture subtle changes in neurological function and fail to reveal the full picture of disease progression.

Digital clinical measures enabled by wearables have great potential to transform and accelerate drug development in neuroscience. Digital assessments of function, as quantified from smart sensor data, can provide frequent, objective, and precise measures of how patients function in their real lives. In particular, wearable devices collect continuous digital data remotely and passively, thus improving patient-centricity and reducing trial burden on patients.

Speakers

Jamie Adams, MD, Assistant Professor Director, Movement Disorders Fellowship Department of Neurology Center for Health + Technology, University of Rochester

Jamie Adams, MD, is an assistant professor of neurology and movement disorders specialist at the University of Rochester with a dual appointment in the Center for Health + Technology. Her research focuses on the use of technology, such as wearable sensors, smartphone applications and telemedicine in individuals with neurodegenerative diseases like Parkinson disease and Huntington’s disease. Incorporating these tools into clinical trials may improve outcome measures and facilitate the development of therapeutics.

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Christine Guo, PhD, Chief Scientific Officer, ActiGraph

Christine Guo leads the clinical and data science team at ActiGraph, responsible for the scientific strategy and services supporting ActiGraph‘s leadership in digital medicine. Christine has over 15 years of experience in clinical research and a vision for leveraging technology in clinical trials and practice. Prior to ActiGraph, Christine was Head of Scientific Innovation at Biogen Healthcare Solutions, leading the clinical development and validation of Biogen’s digital medicine products (Software as Medical device) in multiple sclerosis, neuromuscular and neurodegenerative diseases. Christine brings unique scientific insights by bridging across clinical and technical disciplines and is passionate about leveraging data and technology to improve people’s health. Christine holds a B.A. in biological sciences from Peking University and Ph.D. in neuroscience from Stanford university.

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Ruben van Eijk, PhD, Assistant Professor, University Medical Center Utrecht, Department of Neurology

Ruben van Eijk is an assistant professor and medical statistician at the University Medical Center Utrecht (UMCU, department of neurology), specializing in clinical trial design for rare neurodegenerative disorders. Dr. van Eijk studied medicine at the University of Utrecht and received a PhD in clinical trial methodology for amyotrophic lateral sclerosis (ALS). During his PhD, he obtained a master’s degree in medical statistics and has worked as medical statistician at the department of biostatistics of the UMCU. Currently Dr. van Eijk is visiting Stanford University for an annual fellowship at the Center for Innovative Study Design.

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Kristin Hannesdottir, PhD Director of Translational Medicine, Novartis

Bio Coming Soon..

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Jelena Curcic, PhD Data Scientist, Novartis

Dr. Jelena Curcic is a Senior Data Scientist working at Novartis Institutes for Biomedical Research (NIBR) in Basel, Switzerland. She holds a PhD in Biomedical Engineering from ETH in Zurich and her expertise include development, deployment, and advanced analytics of digital biomarkers in Neuroscience. Her special topics of interest are cognition and neuropsychiatric symptoms in Alzheimer’s disease and mood disorders.

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