Slow patient recruitment and poor retention cause recurrent nightmares and perpetual problems often resulting in missing recruitment milestones. The cost of these delays represents hundreds of thousands of dollars for drug and device developers. By recognizing this issue, early detailed feasibility can provide planning and contingency solutions that are focused on reducing the impact of delayed recruitment. Furthermore understanding what motivates investigators and patients to actively participate in clinical studies and how patient recruitment strategies and materials can support all stakeholders to complete studies on time are critical aspects of clinical study delivery planning. During this presentation, an experienced Premier Research feasibility and patient recruitment specialist, reviewed feasibility approaches to address protocol evaluation as well as addressed influences on country selection, site distribution and patient recruitment strategies to provide for more effective clinical trial planning and conduct. For more information, go to http://www.premier-research.com.

1. 2 0 1 2 PAT I E N T AC C E S S W E B I N A R S E R I E S
Feasibility Solutions to
Clinical Trial Nightmares
March 21, 2012 Presented by Sue Robinson

2. Sue Robinson
 Director of Patient Recruitment
 15+ years of global CRO experience
 Key experience covers:
– In-depth global feasibility
– Strategic patient recruitment and retention
planning
– All phases and across a broad range of
therapeutic areas
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3. What keeps Project
Managers up at night?
3
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4. How can feasibility help?
4
Early, detailed feasibility can provide solutions to all
these nightmares! BUT…..
More commonly in our industry, we rely on
feasibility conducted during the 10 day proposal
process to provide the strategy and planning for
multi million dollar studies and programs!
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5. It’s never too soon
for feasibility for…..
5
Protocol development
Country & site strategy
Recruitment planning
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6. Protocol Development
6
Patient
Placebo Washout assessments Specialist
control periods equipment
tools
Too Complex
Invasive
procedures many diary
visits data
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7. Avoid Protocol
Rejection/Amendments
7
1 Justify study design
2 Explain rescue medication and patient evaluation in detail
3 Match protocol with standard of care
4 Take care when including labs for pediatrics
5 Consider that patients have a life outside of the study
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8. Successful Strategy Development
8
Sponsor
Requirements
Investigator
& Patient Protocol
Motivation Design
Competing Country
Trial and Site Patient
Population
Environment Distribution
Previous Regulatory
Study Environment
Data and
Disease Timelines
Prevalence
2012 PATIENT ACCESS WEBINAR SERIES

9. Investigator and Patient Motivation
9
What are the motivations to join a study?
Investigators Patients
1) Scientific interest/recognition/ 1) Access to relief of symptoms
publication etc. 2) Long term treatment of illness
2) Benefit of better treatment 3) Regular check ups and contact
options for patients with medical staff (TLC)
4) Reduced treatment or clinic
3) Lower costs of treatment for attendance costs
site and/or patients
5) Education and information
4) Appropriate fee about their condition/study/
treatment options
5) Funds for improved 6) Meeting others with same
equipment/ facilities illness
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10. Recruitment Planning
10
Know you target
Balance
Identify the ideal patient recruitment time
site profile with site numbers
population and distribution
Data collection is key
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11. Questionnaire Lottery
11
Feasibility data isn’t just about estimated
recruitment rates from investigators
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12. The Patient Funnel
12
RA patients who haven’t had
biological therapy in last 3 months
Do you have a database of RA patients?
If yes, how many on your database?
# of RA patients seen per month
% treated with
biological therapy
# biological therapy
failures per month
# newly diagnosed
RA pts
seen per
month
Target
pt
pool
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13. The Patient Funnel
isn’t the Complete Story…
13
Other influences include:
Phase and Complexity of Investigator Patient
recruitment
study design study protocol grant approaches
Reimbursement Investigator/
Access to for equivalent Competing
assessments studies site staff
treatment and motivation
assessment
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14. Feasibility in Practice:
A Case Study
14
 Phase 2, placebo controlled study
 Requiring ~800 FI patients with minimal scar tissue
with moderate to severe FI symptoms
Feasibility: Protocol Site
6 weeks update: identification:
(+2 weeks KOLs) 4 weeks 4 weeks
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15. Feasibility Summary
15
 Data from 104 sites Interested sites
8
in 21 countries globally
7
 Highest level of interest 6
found in Europe 5
4
 Diverse range of physicians
3
and healthcare professionals
2
see these patients
1
 Limited previous study activity 0
mainly in devices, injectables
and nerve stimulation
 Many patients are not actively treated in the sites, many are in other institutions,
healthcare facilities or in many cases not seeking medical advice but self
medicating
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16. Protocol Updates
following Feasibility
16
Change of FI assessment score Reduced patient numbers
Reduced post screening Patient evaluation
run in period procedure modified
Modification to Refined diary data
extended first visit to be collected
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17. Country Selection
17
 Five regions assessed but low interest
from AP & LA
 Countries selected based on level of Regional % Split of Patients
interest and recruitment potential
19%
North America 29%
Western Europe
 Main response from WE & CEE
 US included for marketing purposes 52%
Central and Eastern Europe
 Recruitment expected to be higher in
CEE based on feasibility results
 Majority of sites confirm they would
need outreach/advertising to support
recruitment
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18. Build Patient Recruitment Strategy on
Feasibility Data and Local Knowledge
18
40
30
20
10
0
Gastroenterologists are the ideal site
but many others see these patients
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19. Build Patient Recruitment Strategy on
Feasibility Data and Local Knowledge
19
100%
80%
60%
40%
20%
0%
CEE NA WE
Lack of patients Not interested Study design
Lack of resources Competing study
Main reason for declining is lack of patients...
...but could sites be interested
with supported outreach and referral
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20. Understand the FI Patient Flow
20
Patient seeks Primary Physical exam
help for confirms FI with Surgeon
symptoms of FI Care MD rectal damage
Geriatric/
Physical exam Community
confirms FI without
rectal damage Care
Gastroenter- Surgery
ologist/
Gynaecology
Biofeedback/
Nerve Maintenance
stimulation/ therapy/care
Bowel training
Pharmacy/
Internet –
self medication Adequate response
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Inadequate response

21. Patient Recruitment
Challenges Identified
21
 A topic not openly discussed – quite frankly it’s embarrassing
 Our patient population is hidden – only 1 in 8 present
 Practicalities of travelling to sites for visits – limited reach of
patient catchment area
 Overcoming specific hurdles of protocol at the crucial consent
stage
 Intrusive exams
 Treatment free run-in period
 Long first treatment visit in clinic
 Placebo controlled study
 Significant portion of population potentially excluded due to
presence of cardiovascular conditions
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22. Proposed 3 Tiered Approach
to Material Development
22
Essential Identity, tools for site,
direct to patient
Items outreach and referral
Targeted Press/radio advertising in
Media selected countries, washroom advertising,
website and targeted mailing kit
Campaign
Mini protocol, pre screen checklist, visual
informed consent guide, patient brochure,
Nice to Have conversation guide, print advertorial, banner
advertisement, referral fact card & loyalty
and retention items
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23. Summary
23
Protocol development
Country & site strategy
Recruitment planning
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24. No more nightmares…
feasibility can lead to much
sweeter dreams…
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25. Upcoming Webinars
25
Register at www.premier-research.com/webinars
▪ Optimizing Patient Recruitment in Traditional Markets
18 April at 10:00 am EDT
Speaker: Krista Armstrong, Ph.D.
▪ Leveraging Russia and Ukraine for Patient Recruitment
23 May at 10:00 am EDT
Speakers: Elena Ulyanets, MD and Marina Deniskova, MD
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26. Questions?
Sue Robinson
Director of Patient Recruitment
Email: sue.robinson@premier-research.com
Phone: +44 (0)118 936 4037
www.premier-research.com
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