The presentation discusses the use of wearable devices and sensors for collecting data in clinical trials. While consumer wearables are becoming more common, their data may not be suitable for labeling claims with regulatory agencies without proper validation and approval. Major pharmaceutical companies are exploring how mobile health technologies can supplement traditional trial data collection methods to make trials less costly and more convenient. However, simply having FDA approval as a medical device does not guarantee its data can be used to support drug approval. Proper infrastructure, analytics, and clinical expertise is needed to incorporate sensor data into clinical trials in a way that is robust, secure, and produces scientific results.

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So, My FitBit is Clinical Trial Grade Right?
Keith Wenzel
Senior Director, Solution Incubator
PAREXEL International

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So, My FitBit is Clinical Trial Grade Right?
Yes? No? Maybe?
The ubiquity of consumer grade devices and associated, immediate data
visualization belies the complexity of wearables use in clinical trials

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Wearables in Clinical Trials
• Sponsors are actively evaluating the use of sensors for endpoints, to support drug
marketing/adherence and/or for payor approval
• All major pharma now have innovation groups whose focus includes mHealth (patient
engagement & retention, wearables/sensors, mobile enablement, leveraging social media)
• Drivers include supplemental data, less costly trials (fewer site visits and/or less in clinic
procedures), more timely data collection
• There are many sensors today, but not many yet with high value for clinical trials
• FDA or EU medical device approval does not equate to acceptance of associated data for
labeling claims
• New sensors are coming to market every year and we can expect medical value and data
volume to increase substantially in the coming years

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Wearables Segments

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Wearables Market Size
Frost & Sullivan estimates that the size of
wearables market for clinical trials is $200,000,000

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Opportunities by Therapeutic Area

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Therapeutic area targets

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Smartphone Sensors to Measure Health Outcomes
Source: DIA 2016 Annual Meeting, Byrom

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• Owned by CLINICIANS
• INTERMITTENT use
• “BLIND” evaluation
• RETROSPECTIVE data
• MINIMAL onboard effort
Professional CGM
• Owned by PATIENTS
• CONTINUOUS use
• Displays LIVE data & analysis
• REAL-TIME data
• COMPREHENSIVE onboarding
Personal CGM
Metrics available:
• Time-in-range
• Area –under-curve
• % and # Hypo’s
• Estimated A1C
• Patterns
• Meal/exercise markers
• Post meal response
Source: Medtronic, Inc.
Example Continuous Glucose Monitoring (CGM)

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Patient type N Drug Endpoint
T2 144 Dulaglutide vs Glargine Time in range
T2 598 saxagliptin + dapagliflozin AUC, hypoglycaemia
T1 68 Albiglutide Glycaemic variability
T1 48 Empagliflozin Time in range
T1 500 Insulin A1C and time in range
T2 30 DPP4 Time in range
T1 24 Pramlintide and Insulin Glycaemic variability
Source: Medtronic, Inc.
CGM is already used in diabetes drug development trials

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So, what does the whole system look like?
End-to-end
sensors
components
Reporting and
Analytics

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It’s about the (BIG) data dummy!
“In clinical trials, there are no experts. Nobody has done it, and if you talk to
traditional biostatisticians, they are absolutely paralyzed by fear of having more
than five data points per visit, really. Here we're talking about millions. So we
have to go to unusual players, not unusual for big data, but unusual for health
care. You have to go to people who have been doing it for a good part of the
last 20 years and are getting better at that. These are security experts with the
Federal Aviation Administration that analyzes hundreds of thousands of data
points a second…You actually have to target mathematicians, because
mathematicians understand big data...You have to get out of health care and
certainly out of the clinical trial business to find people who are not scared by
billions, really, billions of data points…”—Sponsor
Source: CTTI Webinar, April 17, 2017; MCT Mobile Devices: Evidence from Sponsors and Investigators Using Mobile Devices

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First it was EDC, then it was ePRO, now its Sensors

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Minimum Components of a Companion App
Schedule
The subject can select the schedule tile icon to
see when measurements are due.
Schedule
The subject can select the schedule tile icon to
see when measurements are due.
Readings Due
The notification icon informs the subject of any
readings that need to be taken on the current
day.
Readings Due
The notification icon informs the subject of any
readings that need to be taken on the current
day.
Support
Selecting this tile icon allows the subject to find
information on how each device should be set
up and used.
Support
Selecting this tile icon allows the subject to find
information on how each device should be set
up and used.
Study Information
The Study Information tile icon provides
information on the subject’s study site.
Study Information
The Study Information tile icon provides
information on the subject’s study site.

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Wearables / Sensors Readings Due Screen
The “Readings Due” page shows the date selected, each of the devices the
subject is allocated to, and when the measurements need to be taken.
The subject will also be able to see the time of
day the measurements should be taken (specific
to study protocol).
The subject will see a notification when results
have been received as well as if a measurement
is still required to be taken.
This will show the subject how many readings
should be taken and how many readings they
have completed for each device.

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End-to-end, secure data transmission infrastructure in place
Robust and scalable platform, by orders of magnitude
Transformative analytics and persona-based visualization
Life Sciences scientific expertise overlay
Incubated within clinical research services processes
Advanced, end-to-end supply logistics
Omni-channel (mobile, web, IoT…)
Multi-cloud integration
So, My FitBit is Clinical Trial Grade Right?

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So, My FitBit is Clinical Trial Grade Right?
 Maybe

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Keith Wenzel
Senior Director, Solution Incubator
PAREXEL International
@lezenewkw
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