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5/22/2015
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1© Copyright 2014 Quintiles
Jochen ZeschkyDirector, Site & Patient Networks, Western Europe20th May 2015
Ohne Patienten keine StudienWie geht eine CRO an dieses Thema heran?
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It’s a Great Time to be a Patient!
From a patient’s perspective things have never look ed brighter.
Never were more drugs under development; with incre asing our
knowledge many patients have access to better care.
More treatments than ever available
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FDA - 2014 Novel New Drugs Summary
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• Innovative approaches are changing the treatment paradigm in oncology, e.g.,
› Converting cancer into a “chronic disease”
› Prevention of cancer through, e.g., vaccination
› Pathway related treatments
• The pathophysiology of neuropsychiatric and neurodegenerative disorders will become more apparent and allow for more targeted treatments, e.g.,
› Receptor imaging as a further diagnostic tool supporting early detection
› Nanotechnology as a part of a targeted therapy
Science Drives New Treatments
Deep insights in underlying mechanisms allow for mo re targeted therapies
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Personalized Medicine is Coming
Translational Medicine translates deep insights fro m biological discoveries into tailor-made drugs and medical devices
Targeted therapies will drive the future growth of medical therapies
Classic MedicineAll patients receive the same therapy
Personalized MedicinePatients are prescreened
to identify responders
Equal efficacy AE / worse efficacyImproved efficacy
CompanionDiagnostics Biomarkers
Targeted Therapies
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Demonstrating product value with more ‘real life’ data of central importance in this environment
Nevertheless, Value Has to Be ProvenDemonstration of healthcare value drives market adoption
“Old Paradigm” “New Paradigm”
• Quality
• Safety
• Efficacy
• Quality
• Safety
• Efficacy
• Value
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Drug DevelopmentCost Explosion
10,000 to 1
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Janet Woodcock, Center for Drug Evaluation and Research, FDA
Each time a new drug is tested, the process is repeated, at great expense, only to dismantle the infrastructure
when the study is completed. We believe that there areways to greatly improve clinical trial efficiency, such as
widespread use of clinical trial networks and masterprotocols…..
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• The Patient is „Center stage“
• What are a Patients needs?
• What does the Patient think?
Patient CentricityTurning the Industry on its Head
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Patient centricity is remembering why we do what we
do, it is not about developing a drug; it’s about helping
patients and bringing much needed therapies to them.
There are many ways of demonstrating patient
centricity - with one being ensuring that patients
know what their options are for their care,
including participation in clinical trials.
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Recruitment Strategies
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Recruitment StrategyRecruiting the most qualified patients as cost effectively as possible
Site Recruitment
Qua
lifie
d P
atie
nts
Cost
Site Recruitment
Patient PreID Recruitment Tools
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Educate and Recruit the “right” Patient
Over 50% of sites use brochures to recruit patients and approximately 40% use ICF
tools. A well-informed patient is more likely to be compliant and committed to the
study.
Study brochures and ICF tools
Highlight study benefits in recruitment tools.
Members of Quintiles patient communities have told us that comprehensive evaluations, medication, supplies, diet and exercise counseling, as well as advancing research, are benefits of study participation
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Recruitment Strategy
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EpocratesPhysician Outreach
Recruitment StrategyRecruiting the most qualified patients as cost effectively as possible
Site Recruitment
Physician Referrals
Qua
lifie
d P
atie
nts
Cost
Site Recruitment
Physician Referrals
Patient PreID Recruitment Tools
Outreach to Referral Partners
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• Pharmacies developing their Primary Care role
• Pharmacy Outreach – educating and engaging patients for studies in the Pharmacy
• Patients collecting repeat prescriptions can be flagged for a particular study
• Simple diagnostic procedures done at the pharmacy (BP, travel vaccine etc.)
• Crucial that the site staff are dialled in to receive the subjects via the pharmacy
Pharmacy outreach... for certain studies
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• Picking several patients for your panel
• Used successfully in Bio-banking
• No particular medical background
• Trained on the 4 key talking points to
engage fellow patients in Research
• Target patients waiting in the outpatient
clinic for their appointment
• Ask patients to sign a pledge to support
cancer research at the clinic
The advocate patient
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EpocratesPhysician Outreach
Recruitment StrategyRecruiting the most qualified patients as cost effectively as possible
Site Recruitment
Physician Referrals
Patient Outreach
Qua
lifie
d P
atie
nts
Cost
Site Recruitment
Physician Referrals
Community Outreach
Site AdvertisingMedia Planning /Mgmt
Digital Patient Outreach and Referral
Patient PreID Recruitment Tools
Outreach to Referral Partners
Digital outreach is a component of the recruitment
strategy
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Everything is changing!
Patients (knowledge), Sites (definition), Studies (complexity)... Taking the study to the patient!
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Patients are online — and eager to help
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A little digital context...
• We talk about digital like it is something new - Google is 15+ years old, Facebook is 10 and Twitter is 8...
• Regarding social interaction and conventions, Zuckerberg has changed overnight that which took society over 400 years to establish...
• A downside is beginning to become apparent – Prism & Edward Snowden, Facebook trolling, Twitter bullying, phishing scams etc.
• JPMorgan Chase cancelled question and answer session on Twitter after being flooded with insults, highlighting risks companies take as they experiment with social media marketing
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Accelerate Adoptionand Build Adherence
Enhance Feasibility
Streamline Recruitment
Drive Retention
The Digital Difference
Accelerate Adoption
Strengthen Patient Adherenceand Loyalty
Enhance Product Positioningand Differentiation
Collect Real-World DataDirectly from Patients
Validate and Aggregate Data
Follow Up with Patients Virtually
Streamline ProductDevelopment
Prove Product Value and Safety
How digital patient engagement is transforming the industry
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Patient insights for study designCollect direct patient feedback to better understand needs, beliefs and behaviors (Patient Centricity)
• Your condition...
• Your medication...
• Your other symptoms...
• Your needs andpreferences...
• Why would you join a study?...
Insightsgatheringapproach
Outreach toPatient communities and digital universe
Analysisand report (PDAT)1 2 3
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Pre-recruitment communities for research
Pre-recruit and qualify patients at presentation and looking at trials as treatment options
Collect data directly from lung cancer patients whi le in the community via ePRO, survey, call centre, mobile and digital health devices to build your patient profile evidence and recruit fro future clinical studies
Pre-recruitment community
Future clinical study
Pre-qualify patients in geo-targetedlocations over time
Transition pre-qualified patients to sites for recruitment
Maintain long-term relationships to connect with other research
Direct-to-patient recruitment
and registration
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The virtual study pathway
Technology exists for a virtual study however, there are certain areas in the study process that require further research to find the best solution for a successful study
Video
AudioPatients
InterestedIn Trial
WebcastWeb Portal
Data Aggregation
Electronic Appointment Reminders
Physicians/HCPs
Study Patients
ScreeningEnrollmentConsent
Identity Verification
Paper Chart Reviewer
Incentives
Incentives
SocialMedia
A future model?
An interactive digital solution
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Innovation & Retention
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• New digital innovations require industry to work differently with Sites
• We can not work with a site the same way we did 20 years ago!
• Rather than “push” patients to the clinic through advertising – we are now “pulling” and “retaining” them through Research Nurse engagement
Industry & Clinics together in the engagement of research patients
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• Engaging and educating patients at point of care (outpatients)
• On-boarding touch screen
• Linking to eMR in the back office flagging patients for studies
• Rolling patient education “infomercials” on the clinic Plasma Screen
• Study specific patient education tools
• App messaging
The connected clinic
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• Useful tool across the board, explaining complex protocols simply
• Interactive, touch screen technology
• Built in comprehension algorithms
• 87% of key information common across studies, costs can come down
• More intuitive logic flow than paper
Informed consent animations
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• Clinic visit reminders
• Motivational messages
• Supporting complex regimens/cyclical dosing
• Tracing “Lost to follow-up” patients
• Helpful in long duration studies or multiple
visits
• E-diaries
- Mobile Phone based
- Provides simple data collection tool
• Supporting dynamic consent process
Dynamic SMS consent and motivation
Would youLike to updateYour consent?
YES No
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Rules of Engagement for Consideration• Recruitment
› Plan strategy ahead of the study. Who? What? When?
› Conduct eMR review for potential patients (Feasibility)
› What Partners do I have?
› Social media analysis tools (mapping the geographic distribution of patient populations and scanning social media activity relative to your clinic) Geographical reference!
› Have the resource available to engage patients coming through the various channels
• Retention / Motivation› Use of tablets by subjects as part of clinical trial (gamification)
› SMS text message reminders,
› Adaptation of web based compliance tactics for study compliance (surveys, sms etc)
Digital tactics are only as good as the willingness and investment in the site staff in converting referrals into screened & rando mised patients
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THANK YOUFOR YOUR ATTENTION
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External Public &
CommercialData
SponsorData
Investigator PrimaryResearch
Patient Primary
Research
QuintilesCountry and
Medical Experts
Internal Proprietary
Data
Quintiles study
specific,data driven approach
The Quintiles protocol feasibility approach
• Direct to investigator surveys• Focus groups & discussion forums• Interviews
Leveraging all existing data that Quintiles has (e.g. number of investigators, performance metrics by country/site)
Online direct to patient surveys
Medical, operational, and local review of protocol, materials
Comprehensive mining of publically available data as well as subscription services that Quintiles purchases
• Current development plans• Protocol synopsis• Sponsor-recommended KOLs• Research undertaken to date
Data examples include:• Competing trials• Patient populations and how
they may meet inclusion/exclusion criteria
• Incidence/prevalence• Standard of care and drug
usage• Literature reviews