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BIOMEDICAL STRATEGY - Patient Recruitment Presentation


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Patient Recruitment
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BIOMEDICAL STRATEGY - Patient Recruitment Presentation

  1. 1. Patient Recruitment in Clinical Investigations Orna Oz, PhDBioMedical Strategy (2004) Ltd
  2. 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. 3. Patient RecruitmentStudy Design ManagementInvestigator MonitoringSelection Site Selection Support & Collaboration
  4. 4. Patient Recruitment Post-market . . . Study # 3 Study #2 FIM Investigational/pre-market
  5. 5. Study Design Eligibility CriteriaUnbalanced Eligibility Criteria mightprolong recruitment:Too many exclusions (contraindications)The more stringent exclusion criteria the moredifficult it will be to recruit HOWEVERLack of appropriate exclusion criteria mayleave the study open to additional analysisof (and between) sub-populations
  6. 6. Study Design Experimental ProcedureComplicated (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. 7. Study Design Experimental Procedure Follow Up VisitsMultiple follow up visitsToo many visits; Too oftenClinical assessment at follow up visitsMultiple and out of the ordinary proceduresPatient recruitment+ Compliance with follow up visits (enrolled subjects)
  8. 8. Investigator SelectionOpinion 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. 9. Site Selection A “good site” is:Available to target populationCommunicating with community healthcareproviders (co-physicians or family doctors)Can provide all, by-protocol, required clinicalassessment procedures (Laboratory services,pharmacy services, imaging modalities, etc.)Has qualified and trained personnelDoes not have a language barrier with Company
  10. 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. 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. 12. Company Role Support & Collaboration Continuous and close Management & MonitoringClose monitoring will promptly raise recruiting problemsClose management will enable feedback and adjustedinstructions from and to participating sites regardingproblems and difficulties in recruitment change in studydesign OR study management OR elaborate additionalrecruitment approaches
  13. 13. Recruitment MethodsAdvertising (Newspaper, TV, Radio):Advertisement to recruit subjects should be limited to theinformation the prospective subjects need to determine theireligibility and interest.Direct Mailing No claims should be madeInternet implicitly or explicitly for safety or effectiveness or anyDatabases comparisons to otherPress Releases treatments.
  14. 14. Having said that…..How do we behave in the “real life” scenarios THANK YOU
  15. 15. BioMedical Strategy (2004) Ltd Clinical & Regulatory Affairs GroupFounded by: Gal Ehrlich, Ami Eyal & Orna OzThe Team: Skilled scientists (PhDs in the fields of Physics Chemistry & Biology – TAU & the Weizmann Inst.) Trained in Clinical & Regulatory Affairs
  16. 16. BioMedical Strategy (2004) Ltd Clinical & Regulatory Affairs GroupOur Mission: To coordinate scientific endeavor with clinical & regulatory Affairs for the benefit of our clients’ business milestones