clinical research in the era of the internet of things · © 2018 parexel international corp. / 2...
TRANSCRIPT
© 2018 PAREXEL INTERNATIONAL CORP.
CLINICAL
RESEARCH IN THE
ERA OF THE
INTERNET OF
THINGS
24th April 2018, CTrials, Tel Aviv
Andrea Zobel
© 2018 PAREXEL INTERNATIONAL CORP. / 2
HOW THE IOT ( INTERNET OF
THINGS) TECHNOLOGIES
SUPPORT PATIENTS AND
CLINICAL SITES IN INCREASING
THE SAFETY AND DATA QUALITY
OF CLINICAL TRIALS
• Evolution of Digital Trials
• Patient Centricity Drives
Technology
• Mobile Health Devices
• IoT for clinical supplies
AGENDA
© 2018 PAREXEL INTERNATIONAL CORP. / 3
BOSTON, MASSACHUSETTS
EVOLUTION OF DIGITAL
TRIALS
© 2018 PAREXEL INTERNATIONAL CORP. / 4
THE INTERNET OF THINGS (IOT) A network of physical objects (devices, vehicles, buildings and other
items) embedded with electronics, software, sensors and network
connectivity that enables them to collect and exchange data
© 2018 PAREXEL INTERNATIONAL CORP. / 5
• File Transfer
• 2-6 Weeks after Collection
• Gigabytes
• Transfer Through the Wire
• Near Real-Time
• Petabytes
• Limited Cleaning Needed
• Data Recorded at the Source and Standardized
• Near Real-Time Analytics and
Visualization
• Data Integration and Cleaning
• Months After Data Collection
• Patient Instrumentation
• Wearables/eLabel
• Mobile
• Medical Records
• Genome Database
• Data entered manually in different
systems
• Lab systems
• Paper
DIGITALIZATION CHANGES THE WAY WE MANAGE DATA
IN CLINICAL TRIALS
THE FUTURE (Real time, predictive, data driven decisions)
THE PAST (Slow, reactive, siloed)
Data Collection
Data Transfer
Visualization & Reporting
© 2018 PAREXEL INTERNATIONAL CORP. / 6
• Analytics & Artificial intelligence
• Automation
• Best of breed systems
• Data quality
• IoT and Real-time analytics
• Site and home based modalities, including
post-marketing phase
• Integrated Project Management and
clinical trial supply logistics
Decision of optimization
TWO KEY AREAS OF DIGITAL TRANSFORMATION
A QUALITY AND INNOVATION AGENDA
Patient and site services
Driven by outsourced cloud services
Enabled through patient & site engagement
© 2018 PAREXEL INTERNATIONAL CORP. / 7
BOSTON, MASSACHUSETTS
DIRECT TO PATIENT
FROM PROTOCOL
TO EXECUTION
PATIENT
CENTRICITY DRIVES
TECHNOLOGY
© 2018 PAREXEL INTERNATIONAL CORP. / 8
WHY IS PATIENT CENTRICITY IMPORTANT?
36%
50%
10%
4%
86% of 971 pharmaceutical industry executives
surveyed agree that patient centricity is the best
route to future profitability.
Strongly agree
Agree
Not sure/neutral
Disagree
I believe a focus on patient-centricity is
the best route to future profitability
Industry Healthcheck 2014: Testing the health of the pharmaceutical industry,
© 2018 PAREXEL INTERNATIONAL CORP. / 9
WHY VIRTUAL TRIALS?
*http://mediaroom.sanofi.com/sanofi-launches-digital-clinical-trials-to-improve-recruitment-and-reduce-trial-times/#!
***http://www.fiercebiotech.com/cro/sanofi-launches-new-virtual-trials-offering-science-37
**https://forteresearch.com/news/infographic-retention-in-clinical-trials-keeping-patients-on-protocols/
1 HOUR
2 HOUR
of potential participants
live more than 2 hours
away from their nearest study
center, which limits recruitment
and retention**
70%
There are currently >40,000
clinical studies recruiting in the U.S.
80%
delayed due
to recruitment
problems*
85%
of clinical trials FAIL TO
RETAIN
enough patients
30%
AVERAGE
DROPOUT
RATE across all
clinical trials***
© 2018 PAREXEL INTERNATIONAL CORP. / 10
VIRTUAL TRIAL STAKEHOLDER VALUE
PATIENT SITE
• Makes trials more
accessible by reducing
visit burden
• Increases convenience for
patients with busy lives,
mobility issues and/or
travel restrictions
• Enhances understanding
and ownership of their own
healthcare
• Improves safety due to
real-time user feedback
• Reduced workload
• Positive study
experience for their
patients
• Accelerated recruitment
• Enhanced patient
retention
• Educational experience,
helping site staff stay
current as trial deployment
evolves
• Better insight into patient
health outside of visits
• Broadens the patient pool
to accelerate recruitment
• Enhances patient
retention
• Meets innovation/ patient
centricity goals
• Provides PR opportunity
• Increases revenue
resulting from faster
market launch
• Improved data quality and
speed
SPONSOR
© 2018 PAREXEL INTERNATIONAL CORP. / 11
PATIENT CENTRICITY SERVICES
eCONSENT
PATIENT
ADVOCACY GROUP
RELATIONSHIPS
ONLINE PATIENT
STUDY COMMUNITES
Study Contacts
PATIENT APPS PATIENT CENTRIC
PROTOCOL
OPTIMISATION
LAY STUDY RESULTS
& PARTICPATION
THANK YOU
DIRECT TO/FROM
PATIENT TRANSPORT
WEARABLES
TREATMENT AT
PATIENT‘S HOME
ICF VIDEO
SUPPORT
© 2018 PAREXEL INTERNATIONAL CORP. / 12
PATIENT APP - FUTURE EVOLUTION
• Visit and dosing patient reminders
• Subject self-report of study dosing
• Study messaging
• Patient eConsent
• Visualizing the patient journey
through the study lifecycle
• Study site contact details and after
hours instructions
• Note taking for discussions at site
• Alerts to site based on study-
configured triggers
• eCOA/ePRO data entry and
integration
* Features to be prioritized and released over time 12
Wearable
Apps
PA
TIE
NT
Engagement
APP
eCOA
VIDEO
DOSING Tele
Health
Visit
eConsent
STUDY #
Patient App
© 2018 PAREXEL INTERNATIONAL CORP. / 13
BOSTON, MASSACHUSETTS
MOBILE HEALTH DEVICES
© 2018 PAREXEL INTERNATIONAL CORP. / 14
Data Visualization for Sites
and Study Teams
Secure, wireless transmission
Novel endpoints or
supplementary data
• Collection of biometric data direct to
smartphones/data transmission hubs
• Device and smartphone/hub supplied
ready-paired in provisioned studies
PATIENT SENSE
EXAMPLE DEVICE OPTIONS
MOVEMENT
SENSORS
BLOOD PRESSURE
METERS
BODY SCALES
PULSE
OXIMETER
GLUCOMETER
SPIROMETER
/ PEF
© 2018 PAREXEL INTERNATIONAL CORP. / 15
SENSORS PLATFORM – OVERVIEW
Remote Central
Visualization DB
Results DB
Device allocation
Device library
Persona based visualizations
Dataset export
2nd Net Hub
2nd Net Platform
Device allocation
© 2018 PAREXEL INTERNATIONAL CORP. / 16
ANALYTICS – ACTIVATING THE DATA
Ability to compare across
study subjects
In depth visualization down to the
study subject level over time.
16
Compliance metric for
each patient.
© 2018 PAREXEL INTERNATIONAL CORP. / 17
VISION: NEXT GENERATION SENSORS PLATFORM
COMPLEMENTED BY A PATIENT APP
End-to-end Sensor-based Solution
© 2018 PAREXEL INTERNATIONAL CORP. / 18
TAIPEI, TAIWAN
IOT FOR THE
CLINICAL SUPPLY
CHAIN
© 2018 PAREXEL INTERNATIONAL CORP. / 19
SITE
Depot
Local Depots Storage, Expiry Updates
PAREXEL
IRT System
INTEGRATED SUPPLY CHAIN ACTIVE TRACKING, RTSM MOBILE APP, E-LABEL COMBINED
Labelling, Storage Randomization, Inventory IMP
Manufacturing, Primary Packaging
Manufacturer Shipment
Order
IPTrack
Dispatch
Import
IMP data
Dispensing
Release
Quarantine Active
Tracking
IRT Mobile App
Patient Engagement App
© 2018 PAREXEL INTERNATIONAL CORP. / 20
REAL-TIME TEMPERATURE
Secondary
Packaging
(Optional)
Temperature
Controlled
Shippers
“Active”
Temperature
Logger
Distribution
from Depot
to Sites
IRT System
for automatic
analysis,
quarantine
and release
FULL VISIBILITY OF SUPPLY CHAIN REDUCING SITE EFFORT & INCREASING OVERSIGHT
© 2018 PAREXEL INTERNATIONAL CORP. / 21
E-LABELLING
DRUG INFORMATION FOR PATIENTS AND SITES
Connect medication to
RTSM Mobile App and
Patient Engagement App
Allows easy tracking and
additional information
E Labels
Barcoded
Packages
Intelligent Packages
Change label text e.g. expiry
date and study code by
external signal
Allows easy updates and
pooling by IRT integration
Track and transmit data e.g.
temperature, drug
consumption by sensor
Allows real time tracking and
provide compliance data
Links the medication package to
IRT and study systems
Allows direct interaction of patients and sites with the medication package
© 2018 PAREXEL INTERNATIONAL CORP. / 22
SMART PACKAGES FOR COMPLIANCE TRACKING
IRT System
© 2018 PAREXEL INTERNATIONAL CORP. / 23
REGULATORS SPONSORS SITES PATIENTS
Better recuitment
Reduced Workload High Quality Data
Fast Development
Regulatory compliant
GXP, Data Privacy
ULTIMATE GOAL: HAPPY, ENGAGED STAKEHOLDERS
More support and
information
© 2018 PAREXEL INTERNATIONAL CORP. / 24
THANK YOU
© 2017 PAREXEL INTERNATIONAL CORP. / 24