Engaging Patients in Research to Increase Efficiency and Generate Real-World Data

Chris Kula-Przezwanski

Partnering Director

Quintiles Digital Patient Unit

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THE ENVIRONMENT

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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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QUINTILES’ SOLUTION FOR ENGAGING PATIENTS

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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

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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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THANK YOU

Engaging Patients in Research