Digitally connected devices are transforming the way we treat and manage health conditions. They also introduce and improve participant access, engagement, and outcome measurements in clinical trials. Here’s a look at how digital data is paving the way for advances in treatments and recovery.
How Wearable Sensors are Improving Data
The expanding use of wearable sensor technologies allows the collection of continuous, high-resolution data in patients’ real-world environments for extended periods of time, providing researchers with an unprecedented level of insight into patients’ physiological and behavioral states. These types of data more accurately describe a patient’s experience and enable scientific insights not previously available to researchers. These are the ways digital data will replace traditional data:
- Real-world setting data to replace clinical setting data
- Long-term, continuous data to replace periodic assessments
- Objective data to replace subjective data
- Continous data to replace offline analytics
Researchers can more accurately determine which medications and treatments are most appropriate for certain patients with real-world evidence, leading to individualized care and improved outcomes.
Assessing a Person’s Functioning
Physical function and mobility endpoints are relevant to most, if not all, clinical indications. Traditional in-clinic performance tests, such as the 6-Minute Walk Test and the Timed 25-Foot Walk, often comprise primary and secondary endpoints in neurodegenerative, cardiorespiratory, and rare diseases. Wearable actigraphy sensors provide an opportunity to capture real-world evidence including the types of behaviors in which a patient participates.
For example, in conventional trials, a patient is often required to make several scheduled site visits. Traveling may impact the disease state or treatment while causing significant disruptions to daily life. Short clinical snapshots at the site may not capture a patient’s best effort or provide an inaccurate measure of drug effect. Decentralized trials enable a more accurate measurement of the patient’s functioning.
B6ME Is a Real-world Solution
Best 6-Minute Effort (B6ME); is a novel outcome assessment that helps researchers understand how disease impacts patient functioning. It identifies the best six-minute effort whenever the patient happens to make it rather than during the clinical site visit. B6ME provides a continuous measure of physical activity, steps taken, distance walked, cadence, duration of effort, and time of day at which this effort occurred. An in-clinic 6MWT is made at a predetermined time when the study subject may be preoccupied or fatigued.
Using a wearable sensor to measure B6ME, a detailed understanding of functional mobility can be derived. B6ME provides accurate insight into how patients function during their everyday activities, reducing the need for burdensome on-site visits.
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