The arrival of connected digital technologies, such as wearable biosensors and mobile devices that enable the passive measurement of parameters such as sleep, activity and heart rate, has the opportunity to revolutionize the capture of data from clinical trial participants.
Such technologies present the possibility to collect data continuously and extract from the data new digital biomarkers that are more precise, patient-centric, clinically meaningful and objective compared to current methods used in research, such as subjective rating scales and patient diaries.
Actigraphy is a non-invasive and well-tolerated method to collect continuous rest-activity data for extracting exploratory outcome measures on sleep, circadian rhythm and movement (physical activity/inactivity, gait, symptoms in movement disorders). We deploy devices with 3-axis accelerometers that are 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 on the body sensors are best worn depends on the particular endpoint.
*currently implemented in clinical research at IXICO
Combining the best emerging wearable technology together with our digital platform and scientific and regulatory expertise, we are partnering with biopharma companies to discover and clinically validate new digital biomarkers for deployment in regulatory compliant clinical trials.
We are developing and validating new machine-learning disease specific algorithms to analyze wearable biosensor data to improve the sensitivity and specificity of standard algorithms to measure physiological parameters such as sleep, activity and circadian rhythm.
To support our innovation, we are funding studies to gather actigraphy data, alongside other clinical measures.
Today, digital biomarkers provide pharma companies with supplemental, contextual information to arrive at clinical trial Go/No Go decision more confidently and efficiently.
Our strong regulatory track record and digital technology capabilities means that we are at the forefront of developing and validating digital biomarkers.
As a new and emerging technological advancement, we are actively participating in consortia and engaged with regulatory bodies to continue to validate digital biomarkers and develop the pathway to support the use of digital biomarkers as endpoints in clinical trials to support regulatory approval.