Engaging Patients in Research to Increase Efficiency and Generate Real-World Data
Chris Kula-Przezwanski
Partnering Director
Quintiles Digital Patient Unit
3
Research Challenges
• 2005: PRNewswire reported that patient recruitment was the leading
cause for missed timelines in clinical trial deadlines
• 2007: a survey by Centre Watch reported that of 25,000 studies in the
USA, 90% cited patient recruitment as a reason for missing study
deadlines
• 2009: Datamonitor reported that “around 90% of clinical trials are
delayed because of patient recruitment problems, and this is particularly
acute in large studies such as those involving cardiovascular or central
nervous system disorders”
• 2011: PMLive reported that “Industry sources believe that up to 95 per
cent of the delays in completing clinical trials are caused by slow and
inefficient recruitment”
So where do we go from here?
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Clinical Trial Naïve Patients Unfamiliar with Studies, but Recognise Importance
• Community-based patients are unfamiliar with clinical trials
Up to12% have previously
participated in a study
64% not at all or a little familiar
• Yet studies are recognised as important to development of new medications
93% rate as very or extremely
important
• Most patients don’t participate because they are unaware of study opportunities
68%
16%
8%
6%
2%
2%
0% 25% 50% 75%100%
Not aware of CTs
Concern aboutinvestigational med
Travel distance
Don't want todiscontinue meds
Concern aboutplacebo
Visits require toomuch time
Why Haven’t You Participated in
a Study? (n=75)
Source: MediGuard UK member survey, May 2011, n=150 (50 England, 50 Scotland, 50 Wales).
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Rapid Adoption of the Internet Has Resulted in the Emergence of the Patient as a Key Stakeholder for Research
• Patients are increasingly seeking information on their conditions/medications
A study by PEW in 2011 showed that ~60% of all patients are
searching for health/medical information on-line
• This trend will continue to grow as:
The population ages
Technology continues to expand internet access
(PCs, Tablets, Smartphones, Apps, The Cloud)
• How does this affect clinical research?
Patients are empowered to influence care decisions and to participate
in research without their personal physician
Internet allows for rapid access to large pools of patients
Email allows for cost-effective, bi-directional communication
(information push, pull for data capture/screening)
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Quintiles Has Invested in a Secure Platform and Front-end Services to Engage with Digital Patients
• Profiled patients who have
consented to participate in
research activities
~3.0 million members
across the US, UK,
France, Germany, Spain,
Australia and Brazil
13,000+ in the France
Asia Pacific next
• Global platform for
messaging and data
capture (bi-directional)
• Proven techniques for
patient outreach
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Digital Patient Platform
The
industry’s
leading,
privacy-
protected,
global
environment
from which to
host unique
patient
communities
and the tools
and
processes to
operate them
Patient Knowledge Warehouse
Admin
Site/
Security
Enrollment
Channels
Tags
Se
cu
rity
Über
Query Tool
Survey
Tool API
Global Gift
Fulfillment
Enigma
Data
Token Tool
ClinicalResearch.
com
Messages
(email,
SMS, fax)
Custom Patient
Programs
MediGuard.org
Custom Patient
Communities
Fully customisable front
end services (including
Quintiles’ DPU sites)
Patient relationship
management tools used
in more than 28 million
patient interactions
Nearly 2 billion data fields
and 3 million clinically
profiled patients
Leveraging Quintiles Technology to Deploy “Private Labeled” Services
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Digital Patient Solutions
Research enabled by going direct to patient
Clinical
Studies
Observational
Research
Disease
Management
Feasibility: Optimise your protocol before first
patient enrolled.
Recruitment: Save time and money by engaging
digital patients for referral to sites.
Retention: Engage with patients to boost
retention and maintain relationship
post study.
Real-World
Outcomes: Collect observational data more
efficiently.
• Measure burden of illness
• Justify market value
• Compare product effectiveness
• Validate PRO instruments
Program Design &
Evaluation: Leverage patient feedback to create
and continuously improve upon
tailored programs.
Patient Adherence: Maintain a two-way dialog with your
patients to help ensure compliance
and persistence.
Patient Portal: Integrate PRO data with EMR to
improve patient outcomes and
demonstrate meaningful use to
physicians and payers.
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MediGuard Patient Survey Experience, 2009-2012
Condition
Studies
Completed Patients
Screened Patients
Enrolled Country
CNS (depression, bipolar, ADHD) 42 10,901 1,356 US,UK
Metabolic (diabetes, obesity) 48 6,749 3,627 US,UK
Arthritis (RA, OA, psoriatic, gout) 39 8,686 2,574 US,UK
CV (AF, CHF, cholesterol, HTN) 44 9,086 2,401 US,UK
Neurology (PD, AD/Dementia, epilepsy, RLS) 32 5,991 1,136 US,UK
Respiratory (Asthma, COPD) 17 7,235 1,124 US,UK
GI (GORD, Crohn's, UC, constipation) 20 7,723 1,348 US
MS 24 3,555 2,563 US,UK
Women's Health (contraception, osteoporosis,
menstruation) 12 2,860 802 US,UK
Infectious disease (Hep C, HIV) 12 1,114 773 US
Pain 11 2,854 514 US
Cancer 13 1,247 486 US
Chronic Kidney Disease 7 1,570 311 US
Allergies 5 1,056 167 US,UK
Lupus 4 899 200 US
Dermatology (psoriasis, dermatitis, CIU) 5 415 125 US
As of July 16, 2012
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Partnership Example
• Launched in June 2012, Quintiles Digital Patient
Unit partnered with American Diabetes
Association to develop “My Medicine Tracker” to
support patients with diabetes in:
Tracking and printing a list of all
their medications, both prescription
and OTC
Viewing safety information
regarding side effects and
contraindications
Receiving email alerts and updates
on important safety information
about medications
Interacting with other members to
share experiences such as
tolerability issues
Participating in research studies
American Diabetes Association’s Private Labeled Site
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Working Together to Further Research
• Potential Touchpoints
Co-branding Quintiles services to
support patients within the Partner
catchment area
MediGuard.org (medication
monitoring)
ClinicalResearch.com (clinical trial
matching)
Developing a Partner Clinical Trial
“Alumni Community” to maintain
relationship with previous clinical trial
subjects
Patient portal to capture PRO data and
integrate with EMR to evaluate
meaningful use for physicians and
payers
Joint clinical, observational, and
disease management research
programs
• Benefits
Ongoing connectivity with patients
Expansion of support services
provided beyond hospital and/or
physician visits
Increased patient engagement and
participation in research
Expansion of the types of research
programs possible through direct
connection with patients
Enhanced reputation of institution
by patients
Options for a Partnership Around Digital Patients
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