feasibility solutions to clinical trial nightmares
DESCRIPTION
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.TRANSCRIPT
2 0 1 2 PAT I ENT ACCES S WEB INAR S ER I ES
Feasibility Solutions to
Clinical Trial Nightmares
Presented by Sue RobinsonMarch 21, 2012
2012 PATIENT ACCESS WEBINAR SERIES
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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What keeps Project Managers up at night?
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How can feasibility help?
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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It’s never too soonfor feasibility for…..
Protocol development
Country & site strategy
Recruitment planning
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Protocol Development
Complex diarydata
Too many visits
Invasive procedures
Specialist equipment
Patient assessments
tools
Washout periods
Placebocontrol
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Avoid Protocol Rejection/Amendments
Justify study design1
Explain rescue medication and patient evaluation in detail2
Match protocol with standard of care3
Take care when including labs for pediatrics4
Consider that patients have a life outside of the study5
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Successful Strategy Development
ProtocolDesign
Investigator& Patient
Motivation
DiseasePrevalence
SponsorRequirements
PreviousStudyData
CompetingTrial
Environment
PatientPopulation
RegulatoryEnvironment
andTimelines
Country and Site
Distribution
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Investigator and Patient Motivation
Investigators
1) Scientific interest/recognition/ publication etc.
2) Benefit of better treatment options for patients
3) Lower costs of treatment for site and/or patients
4) Appropriate fee
5) Funds for improved equipment/ facilities
Patients
1) Access to relief of symptoms
2) Long term treatment of illness
3) Regular check ups and contact with medical staff (TLC)
4) Reduced treatment or clinic attendance costs
5) Education and information about their condition/study/ treatment options
6) Meeting others with same illness
What are the motivations to join a study?
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Recruitment Planning
Balance recruitment time with site numbers and distribution
Know you target patient
population
Identify the ideal site profile
Data collection is key
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Questionnaire Lottery
Feasibility data isn’t just about estimated recruitment rates from investigators
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Targetpt
pool
Do you have a database of RA patients? If yes, how many on your database?
# of RA patients seen per month
# biological therapy failures per month
# newly diagnosed RA pts
seen per month
% treated with biological therapy
The Patient Funnel
RA patients who haven’t had biological therapy in last 3 months
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Phase and study design
Complexity of study protocol
Access to assessments
Reimbursement for equivalent treatment and
assessment
Investigator/site staff
motivation
Competing studies
Investigator grant
Patient recruitment approaches
The Patient Funnel isn’t the Complete Story…
Other influences include:
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Feasibility in Practice: A Case Study
Phase 2, placebo controlled study
Requiring ~800 FI patients with minimal scar tissue
with moderate to severe FI symptoms
Feasibility:
6 weeks (+2 weeks KOLs)
Protocol update:
4 weeks
Site identification:
4 weeks
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Feasibility Summary
Data from 104 sites
in 21 countries globally
Highest level of interest
found in Europe
Diverse range of physicians
and healthcare professionals
see these patients
Limited previous study activity
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
0
1
2
3
4
5
6
7
8Interested sites
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Protocol Updates following Feasibility
Change of FI assessment score Reduced patient numbers
Reduced post screening run in period
Patient evaluationprocedure modified
Modification to extended first visit
Refined diary datato be collected
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Five regions assessed but low interest
from AP & LA
Countries selected based on level of
interest and recruitment potential
Main response from WE & CEE
US included for marketing purposes
Recruitment expected to be higher in
CEE based on feasibility results
Majority of sites confirm they would
need outreach/advertising to support
recruitment
Country Selection
29%
52%
19%
Regional % Split of Patients
Central and Eastern Europe
North AmericaWestern Europe
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Gastroenterologists are the ideal site
but many others see these patients
Build Patient Recruitment Strategy on Feasibility Data and Local Knowledge
0
10
20
30
40
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Build Patient Recruitment Strategy on Feasibility Data and Local Knowledge
Main reason for declining is lack of patients...
...but could sites be interested
with supported outreach and referral
0%
20%
40%
60%
80%
100%
CEE NA WE
Lack of patients Not interested Study design
Lack of resources Competing study
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Understand the FI Patient Flow
Patient seeks help for
symptoms of FI
Primary Care MD
Gastroenter-ologist/
Gynaecology
Biofeedback/Nerve
stimulation/Bowel training
Pharmacy/Internet –
self medication
Geriatric/Community
Care
Surgeon
Surgery
Maintenancetherapy/care
Physical examconfirms FI withrectal damage
Physical examconfirms FI without
rectal damage
Adequate response
Inadequate response
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Patient Recruitment Challenges Identified
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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Proposed 3 Tiered Approachto Material Development
Essential
Items
Identity, tools for site, direct to patient
outreach and referral
Targeted
Media
Campaign
Press/radio advertising inselected countries, washroom advertising,
website and targeted mailing kit
Nice to Have
Mini protocol, pre screen checklist, visual informed consent guide, patient brochure,
conversation guide, print advertorial, banner advertisement, referral fact card & loyalty
and retention items
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Summary
Protocol development
Country & site strategy
Recruitment planning
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No more nightmares…
feasibility can lead to much
sweeter dreams…
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Upcoming Webinars
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
2012 PATIENT ACCESS WEBINAR SERIES
Sue Robinson
Director of Patient Recruitment
Email: [email protected]
Phone: +44 (0)118 936 4037
www.premier-research.com
Questions?