passive data collection entails active patients: refocusing the ux lens in clinical trials

Passive TrackingActive Patients!

Todd Greenwood, PhD, MPHDirector Digital Strategy

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Today’s Discussion

1 IoT is Here!

What Matters!

Making it Work!2 3


Faster, better, cheaper!

30%�of clinical trial cost is associated with data management

85%�trials delayed due

to poor patient enrollment

70K�clinical 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


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


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


The digital divide is real!

Is this reality?

30%"owned a smartphone

65 and older (2015):

55%"owned a computer

32%"owned a tablet


Poverty, more than geography, determines who gets online in America

Poverty is also the key determinant of disease burden

Internet Adoption Income


“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

What Matters?Seven Considerations


Digital literacy / Digital access!


Social determinants of health!


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

2.7�million 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)


Designing for health (il)literacy!


Addressing anxiety and paranoia (whether rational or not)!

PROMs!


Privacy – Goes beyond HIPAA!

WHY I GOT A QR CODE TATTOOED ON MY STERNUM By Casey Quinlan


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

Making It WorkPatient-Centric Strategies


Capturing the voice and the lived lives of patients!

Big Data!Analytics!


PD Medical Affairs CRO

Patients

Closing the communication gaps

Inside the Organization

HCPs


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


Activating participants with their own data!


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

Todd Greenwood, PhD, MPH

Thank YouDirector Digital Strategy

[email protected] @medullan

passive data collection entails active patients: refocusing the ux lens in clinical trials

Health & Medicine