Are Sensors and Wearables Really the Future of Data Capture in Clinical Trials?

Over the past few years, we’ve seen the progression from pen and paper to remote and digitized data capture. We’ve also seen the shift from an exclusive focus on clinical inputs to the incorporation of the patient voice. Are sensors and wearables the next evolution?

From pulse oximeters’ remote detection of oxygen levels in COPD patients to accelerometers’ measurement of hand stability in Parkinson’s patients, the use of remote sensors and wearables is enabling continuous, unobtrusive data collection and monitoring that decreases burden on patients while providing more objective data reflective of their real-world experiences.

But, how can we be sure that sensor readings — even when carefully validated, calibrated, and monitored — reflect how patients are truly feeling and functioning? Take fatigue, for example: A sleep monitor may indicate that a patient has had a long sleep cycle. That same patient may provide subjective report the next morning stating they feel exhausted. Each of these datapoints offers up important information, so how do we balance the two in the context of drug development?

How do sponsors ensure that wearable measurements are not just accurate but also meaningful to patients? What should be done when sensor and ePRO data contradict each other?

In this session, we’ll take the audience on the journey of digital data capture, from eCOA to wearables, and discuss key questions, including:

• Tactics for successfully incorporating digital device data collection into your trial
• How to reconcile point-in-time ePRO data with continuous device data
• How to manage and monitor the vast quantities of data transmitted by sensors/wearables
• When to consider novel endpoints
• How to address concerns about data privacy and security

This webinar offers a unique opportunity to gain critical insights into the selection and integration of fit-for-purpose digital instruments, as well as how to ensure accurate data collection in ways that maximize the signal-to-noise ratio and patient comfort.

We look forward to this enlightening discussion with industry veterans on all things sensors and wearables in clinical trials! See you there.

Speakers

Florence Mowlem, PhD, Vice President of Science, ObvioHealth

Dr. Florence Mowlem, PhD, is an expert eCOA scientist who has spent her career advising and guiding clinical research organizations — including industry powerhouses Medable and Signant Health — on the digitalization and remote capture of clinical outcome assessments (COA), as well as the use of connected health devices in clinical trials. Dr. Mowlem holds a PhD in Social, Genetic, and Developmental Psychiatry from Kings College, which has informed her work on the scientific practice of digital endpoint capture. In her pivotal role at ObvioHealth, Dr. Mowlem works with both clinical and technology teams to optimize the implementation of eCOAs according to industry, regulatory and scientific best practices.

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Helen Shaw, PhD, Co-founder, Director, Head of Clinical Operations, VCTC

Dr. Helen Shaw, PhD, is the Co-founder and Director of VCTC, a patient-centric clinical trial site dedicated to bringing clinical research directly to participants through compassionate and expedited site processes. Dr. Shaw holds a PhD in Philosophy with a focus on clinical trial methodology from the University of Birmingham, where she developed early considerations for the use of eConsent in clinical trials. During her 10+ years serving in the industry — including in her current role as Head of Clinical Operations at VCTC — Dr. Shaw has advocated for and participated in the development and implementation of strategies that make clinical research more accessible and less burdensome for participants.

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Ryan Kennedy, Global Vice President of Product (Life Science Global Business Unit), Oracle

Ryan Kennedy has 22 years of experience leading tech innovation in the clinical research industry, specializing in patient engagement and the development of high-value healthcare software solutions. Following his work in direct patient recruitment and trial oversight of investigator-initiated trials at the Hillman Cancer Center, Ryan transitioned into technology development, leading eCOA product teams at ERT (now Clario) and serving as the Head of Product for THREAD Research. At Oracle, Ryan manages the creation of next-generation cloud solutions designed to enhance patient centricity for the life science and healthcare industries. He has a bachelor’s degree in philosophy and neuroscience from Allegheny College and an MBA from the Katz School of Business at the University of Pittsburgh.

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