Connected digital technologies, such as wearable biosensors and mobile devices, enable the passive measurement of parameters including sleep, activity and heart rate. This provides an opportunity to gather data continuously in a ‘real-world’ setting, revolutionizing data capture from CNS clinical trial participants.
With this data, we can extract more precise, patient-centric, clinically meaningful and objective new digital biomarkers compared to more traditional research methods, such as subjective rating scales and patient diaries.
Actigraphy is a non-invasive method of monitoring human rest and activity cycles. It enables the collection of continuous rest-activity data, from which we can extract exploratory outcome measures on sleep, circadian rhythm and movement including physical activity or inactivity, gait, and other symptoms in movement disorders.
We utilize devices with 3-axis accelerometers, capable of recording at high frequency and storing raw data. For sleep assessment, patients typically wear a device on their wrist. For movement assessment, where sensors are best worn depends on the particular endpoint.
Actigraphy and digital biomarker analysis have a range of applications in CNS clinical trials, including:
Sleep disruption is common in neurodegenerative diseases and CNS disorders and may contribute to brain pathology. Collecting sleep data during a clinical trial can provide important additional measures to aid the interpretation of results.
Movement analysis provides valuable information on functional performance in patients with CNS disorders. Wearable devices enable continuous measurement of clinically relevant parameters in real-world settings with a relatively low patient burden.
We aim to improve the sensitivity and specificity of standard algorithms and their ability to measure physiological parameters such as sleep, activity and circadian rhythm.
We are currently developing and validating new machine-learning, disease-specific algorithms to analyze wearable biosensor data. To support our innovation, we are funding studies to gather actigraphy data, alongside other clinical measures.
Digital biomarkers provide pharma companies with supplemental, contextual information to arrive at clinical trial Go/No Go decisions more confidently and efficiently.
Combining the best emerging wearable technology with our digital platform and scientific and regulatory expertise, we partner with biopharma companies across the globe to discover and clinically validate new digital biomarkers for deployment in regulatory compliant CNS clinical trials.
We are actively participating in consortia and engaging with regulatory bodies to develop the pathway to support the use of digital biomarkers as endpoints in clinical trials.