CLINICAL RESEARCH IN THE ERA OF THE INTERNET OF THINGS · © 2018 parexel international corp. / 2...

© 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


BOSTON, MASSACHUSETTS

EVOLUTION OF DIGITAL

TRIALS


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


• 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


• 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



DIRECT TO PATIENT

FROM PROTOCOL

TO EXECUTION

PATIENT

CENTRICITY DRIVES

TECHNOLOGY


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,


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***


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


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


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



MOBILE HEALTH DEVICES


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


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


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.


VISION: NEXT GENERATION SENSORS PLATFORM

COMPLEMENTED BY A PATIENT APP

End-to-end Sensor-based Solution


TAIPEI, TAIWAN

IOT FOR THE

CLINICAL SUPPLY

CHAIN


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


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

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&ved=0ahUKEwjV2-qPkfLQAhUJSyYKHZEuAfsQjRwIBw&url=http://climastore24.net/&bvm=bv.141536425,d.eWE&psig=AFQjCNHRgjKfIjQM6Z8V_xNVKMA9YnR0Ng&ust=1481751595346548

http://online.clinphone.com/


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


SMART PACKAGES FOR COMPLIANCE TRACKING

IRT System


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

http://epsp.pxl.int/ga/hr/Academy/Team/LCDD/LCDD Image Library/Business People/479418495.jpg


THANK YOU


CLINICAL RESEARCH IN THE ERA OF THE INTERNET OF THINGS · © 2018 parexel international corp. / 2...

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Transcript of CLINICAL RESEARCH IN THE ERA OF THE INTERNET OF THINGS · © 2018 parexel international corp. / 2...