Presentation provided by John Reites at DIA 2014 in San Diego, CA on June 17, 2014.

1. Implementing New Technology in Clinical Studies
An Interesting Adventure
John Reites
Senior Director
Health Engagement & Communications
@johnreites
#DIA2014

2. Disclaimer
• The views and opinions expressed in the following PowerPoint
slides are those of the individual presenter and should not be
attributed to Drug Information Association, Inc. (“DIA”), its directors,
officers, employees, volunteers, members, chapters, councils,
Communities or affiliates, or any organization with which the
presenter is employed or affiliated.
• These PowerPoint slides are the intellectual property of the
individual presenter and are protected under the copyright laws
of the United States of America and other countries. Used by
permission. All rights reserved. Drug Information Association,
Drug Information Association Inc., DIA and DIA logo are
registered trademarks. All other trademarks are the property
of their respective owners.
2

3. 3
Biosensors, Health Devices, Activity Bands, etc.
Various options to collect many data points

4. 4
Consumer Devices
Conversion is required for clinical study use

5. 5
Operational Execution
Study methods and design overview

6. 6
“Give me six hours to chop
down a tree and I will spend
the first four sharpening
the axe.”
Abraham Lincoln

7. 7
Direct-to-Patient Enrollment
Fueled via Quintiles Patient Communities
@johnreites 150 US asthma patients enrolled in
3 weeks for biosensor and ePRO study #DIA2014

8. Direct-to-Patient Schedule of Events
8
Patient Experience
Baseline, daily diary,
ACT, smart reminders,
patient direct
payments
Ongoing device
collection –
weekly data sync
Welcome
experience via
digital and mailer
Identification,
consent, and
recruitment
Final assessments
and survey

9. 9
Best Practices
Lessons learned for application on studies with digital health devices

10. 10
Quick Start Guide
Experience friendly instructions are a “must do”

11. 11
Branded Customization
Consent, Creative, Landing Page, Instructions, Reminders, etc.

12. 12
Safety Plan
AE/SAE reporting process and training across partners

13. 13
Application
Programming
Interface
In computer programming,
an application programming
interface specifies how some
software components should
interact with each other
API
Critical to your IT strategy with digital health devices

14. 14
Direct Patient Support
Help and access for patient support via multi-channel

15. 15
Engagement Should Be Expected
Study exit survey data
Extremely or very likely to continue with daily
(digital direct-to-patient) diary only86%
Extremely or very likely to continue with a
different biosensor device83%

16. Thank you
16
@JohnReites
#DIA2014
John Reites
Sr. Director
Health Engagement & Communications
john.reites@quintiles.com
Join the conversation #DIA2014