How Sensor-Enhanced Patient Data Completes the Story of the Trial

Think about the last time a doctor asked How is your sleep pattern? Chances are you probably said “not great” or “fine, mostly.” In some cases, you can’t even remember and might have been tossing and turning. In clinical trials, those answers do matter. But a summary relies on memory, and at that hour, memory isn’t always reliable, especially at 3 a.m.

This is the gap where Dr Helen Brooker, Director of Product and Clinical Data at Signant Health, spends her time. A neuropsychologist by training, she joined Digital Pulse host Trisha Pillay to explain why pairing questionnaires with wearable sensors may be the most practical upgrade clinical trials can make right now. 

Sensor-Enhanced eCOA

Clinical outcome assessments (COAs) are still the backbone of trial endpoints. They’re how patients tell researchers how they feel and function, whether through a clinician interview or a self-reported diary. Brooker doesn’t argue against that, but she shares that questionnaires capture only what people can notice and recall. A wrist sensor works quietly in the background, day and night, with nothing to remember or fill in. Someone might report a poor night’s sleep, and the sensor can show how many times they woke and how long they actually slept.

“You’re missing half of the data when you don’t have sensors,” Brooker said. She was clear that sensors aren’t more reliable than questionnaires, and that isn’t the pitch. The two answer different questions, and the value shows up when they sit side by side.

Her best example comes from eczema research. She described a study of just over 100 patients, followed across roughly 1,600 nights. Each wore a wrist sensor to measure scratching, and each also reported daily how itchy they felt and how they slept. The results appeared in the British Journal of Dermatology in 2023.

How itchy people said they were turned out to be a weak predictor of how much they actually scratched. Brooker was careful to say nobody was being dishonest. What we feel and what our bodies do while we sleep are simply different things. For a condition that wrecks sleep, work and home life, that difference is the whole point. A trial relying on the diary alone would be reading half the chapter.

How Wearables Fit Into Clinical Trial Design

If the value is so clear, why aren’t sensors routine? Brooker has seen this happen before. She spent years in computerised cognitive testing, when plenty of people wanted to stay with paper scales, and it took decades for digital to become standard. Some of the same caution has followed sensors; however, she thinks the fear is fading. Most of us wear a watch or fitness tracker already, so asking a participant to do the same isn’t a big leap. Setup means installing an app and pairing the device, and after that the data flows on its own. The ongoing burden, she said, is mostly charging, and sites can monitor adherence as they go.

Her strongest argument is that none of this disturbs the trial itself. The protocol stays the same, existing COAs run as usual, and recruitment doesn’t change. Sensors ask nothing extra of patients beyond taking part and wearing the device. What does change is volume. A questionnaire might give you one number a week, or one per visit. A sensor gives you something every day and every night. Teams need to decide up front what a meaningful change looks like, just as they would for any traditional assessment, and plan for realities like the odd missed night of wear.

Raw data arrives minute by minute, but device makers have built methods for turning it into measures that fit existing analytic models. Brooker compared it to cognitive testing, where many individual responses get rolled into averages that track change over time. In her view, this isn’t a rewrite of trial design. It’s a change, and it gives sponsors a stronger base for designing the next study.

Regulatory Support for Wearable Endpoints

Regulatory acceptance is often the question that stalls these conversations, and Brooker sounded optimistic. At the end of 2023, the FDA published dedicated guidance on using digital health technologies such as wearables to collect trial data. In Europe, the EMA has qualified a wearable-derived measure, stride velocity, as a primary endpoint in muscular dystrophy.

“It’s not a one-off,” she said. She sees confidence building indication by indication, with each new qualification making the next easier. This momentum is part of why Signet Health acquired Emmetris. Brooker credited the company’s CEO, Roger, with seeing early that sensors and wearables will be part of how trials are run. For her, the deal gives clients a fuller picture of the patient journey and supports broader goals like faster, more affordable drug development and sharper go/no-go decisions.

Brooker suggested that sponsors could start by adding wearables to an existing eCOA study on an exploratory basis. This would allow them to collect sensor data alongside questionnaire responses without affecting the trial’s primary endpoint. It would also help build evidence for the use of sensor data in future clinical trials. “You’re not betting your trial on it,” she said. Brooker expects sensor data to become a standard part of clinical trials, with sponsors increasingly questioning why they ever relied on questionnaires alone.

For more information on what we talked about, visit signanthealth.com and Ametris.com.

Read AI Breast Cancer Screening Moves From Trials to Policy

AI Breast Cancer Screening Moves From Trials to Policy

AI breast cancer screening finds more cancers and cuts radiologist workload, but recall risks remain. See what MASAI, AITIC, and EDITH mean for MedTech teams.

Takeaways

• Integration of sensors and wearables in clinical trials.
• Benefits of continuous passive data collection.
• Regulatory perspectives and approvals.
• Impact on trial design and data analysis.
• Case study: eczema trial with wrist sensors.
• Signant Health and Ametris partnership.

Chapters

00:00 Introduction to sensors and wearables in clinical trials

00:54 Helen Brooker's background and passion for clinical research

03:42 The added value of sensors to clinical outcome assessments

04:06 How sensors provide invisible, objective data

07:40 Real-world example: eczema trial with wrist sensors

10:55 Why sensors are not yet routine in trials

13:52 Signant Health and Ametris partnership for innovation

16:49 Designing trials with continuous sensor data

19:01 Analysing sensor data in clinical trials

20:47 Patient recruitment and data accuracy

22:01 Regulatory perspectives and approvals

25:12 Integrating sensors with established assessments

28:23 Add sensors to existing ECOA studies

29:34 Closing thoughts and future outlook