Presented at the PanagoraPharma Clinical Trials & IoT Forum, November 7, 2016. Sensor technology and connected devices promise a wealth of real-world data for clinical trials without participants seemingly needing to effort. But it’s wrong to conflate the notion of passive data collection with passive patient behavior. Trial subjects need to accept sensor technology and allow it into their lives. Successful trials using IoT connected devices require renewed focus on the user experience, considering how patients, many who may be digitally naïve, adopt and use connected devices. Even when data is collected passively, IoT trials require participants to be engaged, which has significant implications for the design of trials.

1. Passive Tracking
Active Patients!
Todd Greenwood, PhD, MPH
Director Digital Strategy

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We’re Digital Health Experts. !
• 100% Healthcare since 2005
• Steeped in Lean & Learning Development
• Geared for complex collaborations
• Focused on iteratively driving Outcomes

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Today’s Discussion
1
IoT is
Here!
What
Matters!
Making
it Work!2
3

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Faster, better, cheaper!
30%of clinical trial cost
is associated with
data management
85%trials delayed due
to poor patient
enrollment
70Kclinical research trials
occurring at any given
time
$18B"in recruiting costs
in the US alone
64%"reduction in clinical trial
recruitment cost
(MDConenct data)
11K"signed up for
MyHeartCounts in
24 hours

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The vision of digital acceleration in trials!
RW Data Collection
Wearables and sensors
deliver continuous data
Clinical Data
Lean, easily configurable platform
provisioned for clinical trials
Recruitment
Reach the right participants and
quickly screen
Enrollment
Use alternative sites to
enroll, collect baseline
biometrics

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Clinical trials are often unrepresentative!
25%of cancer trial
participants are
older than 65
61%of cancer cases are in
people older than 65
years
32%participants in
Phase II/III trials
60%of national disease
burden bourn by older
Americans

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The digital divide is real!
Is this reality?
30%"owned a smartphone
65 and older (2015):
55%"owned a computer
32%"owned a tablet

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Poverty, more than geography,
determines who gets online in
America
Poverty is also the key
determinant of disease burden
Internet Adoption
Income

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“Perfect Data” from “Imperfect People”!
Cultural Differences!
Consider: expectations about how people
live, work, and eat
Cognitive Differences!
Consideration of differences in ability to learn
and understand instructions
Physical Differences!
Consideration of ability to carry out expected
activities or complete actions
And Daily Life!
Stress, forgetfulness, disorganization and the
general messiness of the real world
Health Differences!
Consider how health status, co-morbidities
affect digital clinical data
Language Differences!
US Census: 350 languages spoken in US
homes

10. What Matters?
Seven Considerations

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Digital literacy / Digital access!

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Social determinants of health!

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8%"of males are
color blind
Usability, accessibility and human factors!
40%of people with
disabilities are
aged 65 and over
6.5"
million use a cane,
walker, or
crutches
2.7million people in the
US who are
wheelchair bound
3.4"million legally blind
in the US alone
1million"Americans are “functionally
deaf” (and half are
over 65 years old)

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Designing for health (il)literacy!

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Addressing anxiety and paranoia (whether rational or not)!
PROMs!

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Privacy – Goes beyond HIPAA!
WHY I GOT A QR CODE TATTOOED ON MY STERNUM
By Casey Quinlan

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Selecting technology w/ consumer focus
(+ FDA approval)?!

18. Making It Work
Patient-Centric Strategies

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Capturing the voice and the lived lives of patients!
Big Data!
Analytics!

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PD
Medical
Affairs
CRO
Patients
Closing the communication gaps
Inside the Organization
HCPs

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Expectations and explanations!
Adaptive!
Design!
PROMs!Big Data!
Analytics!
The What If!
More than FAQs: considering the ways that
things might not as planned
The What For!
Why do the questions that are being
answered really matter?
The Why !
What’s the reason for the trial?
What questions are being answered?
The When!
How long is the trial continuing and when can
I stop wearing/using the sensor technology?
The Who!
“Who you gonna call?” when there are
questions and concerns?
The How!
The reason for using sensors and biometric
devices and how they work

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Activating participants with their own data!

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Getting going!
1. Understand your patient population from the inside out
2. Assess the landscape of IoT and sensor technology devices from a patient perspective
3. Plan and design companion apps using person-centered UX principles that aim to
activate and engage participants
4. Use a lean, agile approach to piloting new IoT technologies prior to roll-out in a trial
5. Ensure that all technology is supported and embraced by CRO and that CRO is aligned
on reducing the digital divide

24. Todd Greenwood, PhD, MPH
Thank You
Director Digital Strategy
tgreenwood@medullan.com
@medullan