1) The webcast discussed perspectives on patient recruitment from sponsors of clinical trials, clinical research organizations, and institutional review boards.
2) Speakers discussed topics like protocol design, feasibility assessments, recruitment strategies, retention, and IRB considerations for proof-of-concept trials.
3) Recruitment simulations and using internal and external data to optimize recruitment timelines and measure success were also covered.
4. Dr. Vince has participated in over 325 clinical trials
His focus is Phase 1 to Proof of Concept
Dr. Vince was involved in the design and
construction of their new 90 bed Early
Development Unit. The objective of this new facility
is enhanced recruitment of patient population trials
and studies with long-term confinement periods.
4
7. Special populations are being enrolled earlier in the
clinical trials process
More Phase I trials (including FIH and MAD) are:
Incorporating patient populations into the study design
Often consolidating SAD/MAD/POC studies into one protocol with an
adaptive design
This depends on:
Safety profile of the compound
Therapeutic area
This approach conserves development time and
provides an earlier read on potential efficacy and
tolerability
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8. Early Physician Feedback Critical
Ensures that:
Safety measures are acceptable
Execution is realistic
Study populations are recruitable
Quick Turn Around (1 week) from the PI or Medical
Director
Should be provided as a no-cost service to clients
8
9. Feasibility Assessments
Speed important, but accurate feedback is more important
In-depth feasibility protects against expensive rescue efforts
PI involvement necessary to validate protocol feasibility at the site
Additional review from clinical operations, regulatory, recruitment, lab
and others minimize costly mistakes prior to study start
Verify accuracy of the metrics from the site
Unfortunately, sites often over-commit
Always have Plan B
9
10. Considerations for Special
Population Feasibility Assessments
Competing trials (not just at the site but in the region)
Competition from marketed drugs
Subject compensation
Time of year
Risk Benefit Ratio
Likelihood of placebo
10
11. Special Population Volunteers ≠ HNV
Recruitment is more challenging
Compensation is not always the priority
Confinement periods are more problematic
Evening call center hours are imperative
Scheduling flexibility (including evenings and weekends)
Usually not “professional”
volunteers
11
12. Accountability – Who is accountable at site level?
Database
Verify it
Bigger is not always better
Advertising
Understand the site’s plan
Advertising dollars should be specific to YOUR study (not generic)
If additional advertising funds are needed…
↑ funds ≠ ↑ recruitment
Market saturation
Competing trials
Skin in the game
12
13. Competition is good (multi-center studies)
Emails, Newsletters
FSFV Milestone, Most Randomized
Call the PI
Confirm Appointments
Welcome packets and handholding
Physician Referrals – Beware
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14. Special population volunteers ≠ HNV
Existing medical co-morbidities
Require additional medical oversight
Concomitant medications
AE assessment
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15. Special population volunteers ≠ HNV
More family involvement
Require more personal attention of P.I.
Have more medical questions
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16. Staff (Warm and Empathetic)
Meals (Hot and Tasty)
Lighting (Bright with Natural Light)
Dorm Size and Assignments (Room to Roam)
Mattresses (Sounds Trivial)
Technology (70’s, 80’s or today?)
Entertainment (Wifi, Movies, How many TVs?, Activities)
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17. Customer Service Training (Serve, Serve, Serve)
Full-time Housekeeper (White-glove inspection)
Bathrooms (Individual and private)
Medical Safety (Highly visible nurses station)
Physician Availability (That’s my P.I.)
Access Outdoors (Sunshine)
Visitors (Welcome; but have a plan and process)
Compensation (Important, but only part of the answer)
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18. Beyond Paper
Using data-driven expertise to enhance patient recruitment
Jeffrey Zucker, MS
Senior Director and Global Head, Patient Recruitment
Kendle
19. Agenda
• Components to successful recruitment planning
• Role of Feasibility
• Use of internal resources
• Accessing external data
• Applying the data to simulate recruitment timelines
• Factoring in recruitment tactics
• Optimizing timelines
• Measuring success
19 N o r t h A m e r i c a • E u r o p e • A s i a / P a c i f i c • L a t i n A m e r i c a • A f r i c a
20. Components
Vendors
Internal
Feasibility
Expertise
Patient Medical
Regulatory
Recruitment Affairs
Key Opinion
Marketing
Leaders
Investigator
Consult
20 N o r t h A m e r i c a • E u r o p e • A s i a / P a c i f i c • L a t i n A m e r i c a • A f r i c a
21. Pillars of feasibility Feasibility
• Previous trials conducted – database/CTMS
• Previous experience with investigators
Internal data
• Regulatory and contract timelines
• Expertise of internal staff and lesson’s learned
• Standard of care for indication and country
• Competing clinical trials
External data
• Disease incidence/prevalence
• Benchmarking/clinical trial intelligence
• Detailed examination of protocol medical team
Medical review • Identify and engage key opinion leaders as needed
and engagement • Develop relationships with key advocacy/support groups
• Internal expertise and relationships
• Validate assumptions
Site-specific
questionnaires • Confirm investigator availability and build interest in trial
• Explore potential patient recruitment strategies
21 N o r t h A m e r i c a • E u r o p e • A s i a / P a c i f i c • L a t i n A m e r i c a • A f r i c a
22. Internal resource Medical
Affairs
Medical
Full review of I/E criteria
Identify barriers and opportunities
• Study design review
Burden on subject and site
Compare to standard of care
Comparison to past trials
• Identify site requirements
Specialty
Geography
Patient access
22 N o r t h A m e r i c a • E u r o p e • A s i a / P a c i f i c • L a t i n A m e r i c a • A f r i c a
23. Internal resource Marketing
Marketing
• Evaluate current therapeutic market globally
Opportunities for emerging markets
• Identify key physicians
Can influence other investigators
• Access to prescription data
Identify “hot spots” for med use
• Competitive information
Pipeline information on other companies
23 N o r t h A m e r i c a • E u r o p e • A s i a / P a c i f i c • L a t i n A m e r i c a • A f r i c a
24. Internal resource Regulatory
Regulatory
• Regulatory timelines are often
underestimated
• Need full review of protocol to
evaluate for country requirements
• Various tactics are not allowed in
certain countries…
…but some are just not typically
used
24 N o r t h A m e r i c a • E u r o p e • A s i a / P a c i f i c • L a t i n A m e r i c a • A f r i c a
25. External resource
KOLs and Investigator consult
Key Opinion Investigator
Leaders Consult
• Clinical protocol guidance • Operational guidance
• Standard of care • Recruitment issues
• Medical trends • Competitive landscape
25 N o r t h A m e r i c a • E u r o p e • A s i a / P a c i f i c • L a t i n A m e r i c a • A f r i c a
26. External resource Vendors
Vendors
• Media buying
• Material development
• Recruitment planning
• Database driven outreach
• Prescription data
• Chart reviewing at sites
• Recruitment workshops
• Website design and maintenance
• Site selection
• Text messaging
• New services emerging daily
26 N o r t h A m e r i c a • E u r o p e • A s i a / P a c i f i c • L a t i n A m e r i c a • A f r i c a
28. Timeline modeling
250 patients
were enrolled
in 16 months
or less 50% of
the time
28 N o r t h A m e r i c a • E u r o p e • A s i a / P a c i f i c • L a t i n A m e r i c a • A f r i c a
29. Recruitment curve
250 patients
were enrolled
in 16 months
or less 50% of
the time
29 N o r t h A m e r i c a • E u r o p e • A s i a / P a c i f i c • L a t i n A m e r i c a • A f r i c a
30. Optimizing probability of success
• Change country mix
• Different distribution of patient allocation
– Over allocate patients/sites
• Back up sites/countries
• Entering additional recruitment tactics
• Propose protocol changes
Re-run the model with new assumptions
30 N o r t h A m e r i c a • E u r o p e • A s i a / P a c i f i c • L a t i n A m e r i c a • A f r i c a
31. Measure performance
• During the trial, clear milestones and contingencies need to be
• Every program needs and after action review
– Identify success, failure, barriers, and opportunities
• Make it an official document that is engrained into the process
• Conduct a team meeting to review results
31 N o r t h A m e r i c a • E u r o p e • A s i a / P a c i f i c • L a t i n A m e r i c a • A f r i c a
32. Summary
• Be sure to use all internal and external resources
– All data is helpful – just be sure you know the validity and reliability
• Use data to support your decisions around study planning
– Modeling recruitment using the data is helpful to generate discussion
• Specific and measureable recruitment tactics
– Work into the model and re-run simulation
• Learn from experience
– Minimize repetition of mistakes
– Leverage knowledge to identify opportunities
• Use common sense when analyzing data and results
32 N o r t h A m e r i c a • E u r o p e • A s i a / P a c i f i c • L a t i n A m e r i c a • A f r i c a
42. IRB Evaluation
Informed Consent Form
• Purpose
▫ Easy to read
The purpose of this study is to measure how much of the
study drug gets into the blood stream and how long it
takes the body to get rid of it.
▫ “First time in Humans”
52. Questions Webcast
Q&A… Thank you for joining us today for our
webcast on ‘Perspectives on Patient
Recruitment’!
If you have any other questions, feel free to contact us at:
Bradley Vince, D.O. Rimmy Junday Kathy Chase, Pharm.D.
President and Medical Director Account Manager Chair
bvince@vinceandassociates.com Langland MLIRB
www.vinceandassociates.com Quadrant Kathy.Chase@cardinalhealth.com
rimmy.junday@langland.co.uk www.mlirb.com
www.kendle.com
