Wearables and digital endpoint generation

An end-to-end approach to managing wearable devices through clinical development

Effective monitoring of clinical trial participants is critical for patient protection and study integrity. However, as the complexity of modern clinical trials grows, on-site monitoring has proven to be expensive and inefficient. As a result, wearable devices have been increasingly used to capture and transmit patient data remotely. These practices increase clinical trial efficiency, while reducing some of the barriers to clinical trial participation, enabling patients to access care from their homes. Other benefits of adopting wearables include:

• Increased patient engagement
• New clinical endpoints
• Robust patient screening
• Real-time compliance monitoring
• More flexible adaptive trials
• Improved data quality

Despite these benefits, wearable devices may present drug developers with challenges when they are integrated in trial design, execution and reporting. As such, it is important to have an end-to-end approach to adopting wearable devices – from device selection to endpoint generation and operational management.

Our team has experience leveraging wearable devices in clinical trials, and can help you develop a framework for device selection and digital endpoints.

Device selection

With new devices entering the market everyday, proper device selection is critical for operational excellence and patient engagement. Study teams and patients must be properly trained so that they are comfortable using study devices.

Other key considerations during device selection include:

• Assessment of study objectives (type of data, blinded/unblinded, therapeutic area, etc.)
• Patient centricity (compliance, patient burden assessment, user friendliness, engagement, etc.)
• Device characteristics (validation, fit for purpose, connectivity, etc.)
• Big data (storage, EDC, etc.)
• Regulatory considerations
• Privacy and security

Digital endpoints

We are committed to advancing methodology and innovation to support novel endpoints. Our clinical endpoints framework is based on proven PRO methodologies to ensure that data collected using wearables meet evidentiary requirements for regulatory submission.

Potential endpoints to be collected using wearables may include:

Sleep Physical activity Posture Heart rate Respiration rate Galvanic skin response Cough Respiratory sounds Seizure PD symptoms

Weight Blood pressure Oximetry FeNo CGM Gait assessment Voice analytics Fine motor skills Temperature Spirometry

Webinar

Digital Endpoint Strategy and Validation

• Present a strategy to identify devices that are "fit for purpose"
• Outline a framework for Digital Endpoint selection and validation to ensure the outcome measurement is robust, reliable, and interpretable
• Address the key considerations that arise when using digital technology to support endpoint generation in clinical studies such as Device Selection, Endpoint Reliability and Sensitivity, Meaningful Change Thresholds, and Analysis Strategy and Interpretation

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