Patient Recruitment in Clinical Investigations

1. Patient Recruitment
in Clinical
Investigations
Orna Oz, PhD
BioMedical Strategy (2004) Ltd

2. Patient Recruitment
It all starts in the definition of the product
“INDICATIONS FOR USE”
• Patient recruitment is a crucial element in
conducting a successful and efficient clinical study
• The study validity depends on recruiting adequate
number of adequate and compliant subjects that
represent the study population

3. Patient Recruitment
Study Design Management
Investigator Monitoring
Selection
Site
Selection Support &
Collaboration

4. Patient Recruitment
Post-market
.
.
.
Study # 3
Study #2
FIM
Investigational/pre-market

5. Study Design
Eligibility Criteria
Unbalanced Eligibility Criteria might
prolong recruitment:
Too many exclusions (contraindications)
The more stringent exclusion criteria the more
difficult it will be to recruit
HOWEVER
Lack of appropriate exclusion criteria may
leave the study open to additional analysis
of (and between) sub-populations

6. Study Design
Experimental Procedure
Complicated (cumbersome) procedure:
• Use (underlying technology and mode of use)
• Too many additional assessments that accompany
the pre and index procedure (MRI, Lab tests, etc…)

7. Study Design
Experimental Procedure
Follow Up Visits
Multiple follow up visits
Too many visits; Too often
Clinical assessment at follow up visits
Multiple and out of the ordinary procedures
Patient recruitment+ Compliance with follow up
visits (enrolled subjects)

8. Investigator Selection
Opinion leader
•Experienced and recognized
practitioner
•Involved in many similar studies
•Low availability Opinion Leader Availability
“Young” Practitioner
•Less experienced and appreciated in the
community
•Highly motivated to participate and recruit
•Relatively high availability

9. Site Selection
A “good site” is:
Available to target population
Communicating with community healthcare
providers (co-physicians or family doctors)
Can provide all, by-protocol, required clinical
assessment procedures (Laboratory services,
pharmacy services, imaging modalities, etc.)
Has qualified and trained personnel
Does not have a language barrier with Company

10. Site Selection
Specializing Hospitals
Familiar with the disease and current procedures
Rare cases, if required by eligibility criteria- this is the
place to find them!
ON THE OTHER HAND
Specializing hospitals usually have a pool of resembling
patients
– Not necessarily representing study population
– Complex patients in terms of health conditions (mainly
complicated morbid patients). Simple cases will take time to
find!
• Are involved in numerous studies with same target
population

11. Company Role
Support & Collaboration
• Maintain ongoing relationships with
participating site personnel
– Communicate with the site on a regular basis,
not only towards or during visits
– Arrange Investigators meetings
– Keep the site involved in the project as a
whole
– Remember special occasions
• Be responsive to their needs and difficulties

12. Company Role
Support & Collaboration
Continuous and close
Management & Monitoring
Close monitoring will promptly raise recruiting problems
Close management will enable feedback and adjusted
instructions from and to participating sites regarding
problems and difficulties in recruitment change in study
design OR study management OR elaborate additional
recruitment approaches

13. Recruitment Methods
Advertising (Newspaper, TV, Radio):
Advertisement to recruit subjects should be limited to the
information the prospective subjects need to determine their
eligibility and interest.
Direct Mailing No claims should be made
Internet implicitly or explicitly for safety
or effectiveness or any
Databases
comparisons to other
Press Releases treatments.

14. Having said that…..
How do we behave in the
“real life” scenarios
THANK YOU

15. BioMedical Strategy (2004) Ltd
Clinical & Regulatory Affairs Group
Founded by: Gal Ehrlich, Ami Eyal & Orna Oz
The Team: Skilled scientists (PhDs in the
fields of Physics Chemistry &
Biology – TAU & the Weizmann
Inst.)
Trained in Clinical & Regulatory
Affairs

16. BioMedical Strategy (2004) Ltd
Clinical & Regulatory Affairs Group
Our Mission: To coordinate scientific
endeavor with clinical &
regulatory Affairs
for the benefit of our clients’
business milestones