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WebcastPerspectives on Patient     Recruitment          Sponsors:
PresentersModerator:Christiane TrueloveEditor‐in‐Chief, R&D DirectionsChris.Truelove@ubm.comSpeakers:Dr. Bradley Vince, D....
Bradley Vince, D.O.President and Medical Directorbvince@vinceandassociates.comwww.vinceandassociates.com       3
Dr. Vince has participated in over 325 clinical trialsHis focus is Phase 1 to Proof of ConceptDr. Vince was involved in th...
5
Discussion Topics: Overview Finalizing the Protocol Feasibility Recruitment Medical Oversight Retention                   ...
Special populations are being enrolled earlier in theclinical trials processMore Phase I trials (including FIH and MAD) ar...
Early Physician Feedback CriticalEnsures that:   Safety measures are acceptable   Execution is realistic   Study populatio...
Feasibility Assessments Speed important, but accurate feedback is more important In-depth feasibility protects against exp...
Considerations for SpecialPopulation Feasibility Assessments Competing trials (not just at the site but in the region) Com...
Special Population Volunteers ≠ HNV Recruitment is more challenging Compensation is not always the priority Confinement pe...
Accountability – Who is accountable at site level?Database Verify it Bigger is not always betterAdvertising Understand the...
Competition is good (multi-center studies) Emails, Newsletters FSFV Milestone, Most Randomized Call the PIConfirm Appointm...
Special population volunteers ≠ HNV  Existing medical co-morbidities  Require additional medical oversight  Concomitant me...
Special population volunteers ≠ HNV  More family involvement  Require more personal attention of P.I.  Have more medical q...
Staff (Warm and Empathetic)Meals (Hot and Tasty)Lighting (Bright with Natural Light)Dorm Size and Assignments (Room to Roa...
Customer Service Training (Serve, Serve, Serve)Full-time Housekeeper (White-glove inspection)Bathrooms (Individual and pri...
Beyond PaperUsing data-driven expertise to enhance patient recruitment        Jeffrey Zucker, MS        Senior Director an...
Agenda• Components to successful recruitment planning• Role of Feasibility• Use of internal resources• Accessing external ...
Components                                                     Vendors                               Internal             ...
Pillars of feasibility                                                                  Feasibility                       ...
Internal resource                                                                           Medical                       ...
Internal resource                                                                        MarketingMarketing• Evaluate curr...
Internal resource                                                                         RegulatoryRegulatory• Regulatory...
External resourceKOLs and Investigator consult            Key Opinion                                                     ...
External resource                                                                        VendorsVendors• Media buying• Mat...
Recruitment simulation Using data to predict success
Timeline modeling                                                                                                         ...
Recruitment curve                                                                                                         ...
Optimizing probability of success• Change country mix• Different distribution of patient allocation     – Over allocate pa...
Measure performance• During the trial, clear milestones and contingencies need to be• Every program needs and after action...
Summary• Be sure to use all internal and external resources     – All data is helpful – just be sure you know the validity...
IRB Considerations in Proof‐of‐Concept Trials   Kathy Chase, Pharm.D.   Chair, MLIRB
Proof‐of‐Concept Research Study• Proof‐of‐principle / concept study• First time in humans• Target disease state
Basic Elements of IRB Review•   Protocol •   Informed consent form•   Recruiting materials•   Safety reports•   Ongoing re...
Fundamental Responsibility of IRBAssure the rights &welfare of the subject is protected• IRB membership• Review process  ▫...
IRB EvaluationDrug Product• Experience   ▫ Animal studies   ▫ In vivo studies   ▫ Human studies• Data source
IRB EvaluationResearch Protocol• Objectives/Purpose• Study Design   ▫ Risk vs benefit   ▫ Healthy vs disease• Subject Sele...
IRB EvaluationResearch Protocol• Study Methods/Procedures/Plan   ▫ Diagnostic testing   ▫ Dose escalation• Adverse Events/...
IRB EvaluationInformed Consent Form
IRB EvaluationInformed Consent Form• Readability   ▫ Eighth grade reading level   ▫ Format
IRB EvaluationInformed Consent Form• Purpose   ▫ Easy to read       The purpose of this study is to measure how much of th...
IRB EvaluationInformed Consent Form• Description of procedures   ▫ Schedule of tests and drug administration   ▫ Diagnosti...
IRB EvaluationInformed Consent Form• Risks   ▫ Animal studies   ▫ In vivo studies   ▫ Human studies   ▫ Similar agents
IRB EvaluationInformed Consent Form• Risks   ▫ Pregnancy risks       Women       Men   ▫ Diagnostic test risks   ▫ Psychol...
IRB EvaluationInformed Consent Form• Benefits• Alternative Therapy
IRB EvaluationSubject Recruitment• Vulnerable populations   ▫ Children   ▫ Prisoners   ▫ Chronic disease• Inducement• IRB ...
Ongoing IRB Actions• Safety analysis• Protocol deviations• Progress reports
IRB EvaluationSafety Reports• Serious adverse events• Report to IRB• IRB actions   ▫ Informed consent modifications   ▫ Pr...
IRB EvaluationProtocol Deviations• IRB review   ▫ Description of deviation   ▫ Intended deviation   ▫ Unintended deviation...
IRB EvaluationProgress Report• Frequency of Review• IRB Analysis   ▫ Safety   ▫ Protocol deviations   ▫ Audit results
Questions                                     WebcastQ&A… Thank you for joining us today for our webcast on ‘Perspectives ...
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R&D Directions Webcast June Final[1]

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Review a webcast presentation from experts from Vince and Associates Clinical Research, MidLands IRB, and Kendle for three presentations that delve into various aspects of clinical trial patient recruitment, from the perspectives of two prominent CROs and an AAHRPP-accredited independent review board. The presentations for this webinar are:

Phase I Patient Population Trials: Feasibility, Recruitment and Long-term Confinement
Speaker: Dr. Bradley Vince, D.O., Vince and Associates Clinical Research

Beyond Paper: Using Data-Driven Expertise to Enhance Patient Recruitment
Speaker: Jeffrey M. Zucker, Senior Director and Global Head, Patient Recruitment, Kendle

IRB Considerations in Proof-of-Concept Trials
Speaker: Kathy Chase, Pharm.D., IRB chair, MidLands IRB; Director, Provider Services, Cardinal Health - Pharmacy Solutions

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Transcript of "R&D Directions Webcast June Final[1]"

  1. 1. WebcastPerspectives on Patient Recruitment Sponsors:
  2. 2. PresentersModerator:Christiane TrueloveEditor‐in‐Chief, R&D DirectionsChris.Truelove@ubm.comSpeakers:Dr. Bradley Vince, D.O., President and Medical Director, Vince and AssociatesClinical Research bvince@vinceandassociates.comwww.vinceandassociates.comJeffrey M. ZuckerSenior Director and Global Head, Patient Recruitment, Kendlerimmy.junday@langland.co.ukwww.kendle.comKathy Chase, Pharm.D. IRB chair, MidLands IRB; Director, Provider Services,Cardinal Health ‐ Pharmacy SolutionsKathy.Chase@cardinalhealth.comwww.mlirb.com
  3. 3. Bradley Vince, D.O.President and Medical Directorbvince@vinceandassociates.comwww.vinceandassociates.com 3
  4. 4. Dr. Vince has participated in over 325 clinical trialsHis focus is Phase 1 to Proof of ConceptDr. Vince was involved in the design andconstruction of their new 90 bed EarlyDevelopment Unit. The objective of this new facilityis enhanced recruitment of patient population trialsand studies with long-term confinement periods. 4
  5. 5. 5
  6. 6. Discussion Topics: Overview Finalizing the Protocol Feasibility Recruitment Medical Oversight Retention 6
  7. 7. Special populations are being enrolled earlier in theclinical trials processMore 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 designThis depends on: Safety profile of the compound Therapeutic areaThis approach conserves development time andprovides an earlier read on potential efficacy andtolerability 7
  8. 8. Early Physician Feedback CriticalEnsures that: Safety measures are acceptable Execution is realistic Study populations are recruitableQuick Turn Around (1 week) from the PI or MedicalDirectorShould be provided as a no-cost service to clients 8
  9. 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. 10. Considerations for SpecialPopulation 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. 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. 12. Accountability – Who is accountable at site level?Database Verify it Bigger is not always betterAdvertising 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. 13. Competition is good (multi-center studies) Emails, Newsletters FSFV Milestone, Most Randomized Call the PIConfirm Appointments Welcome packets and handholdingPhysician Referrals – Beware 13
  14. 14. Special population volunteers ≠ HNV Existing medical co-morbidities Require additional medical oversight Concomitant medications AE assessment 14
  15. 15. Special population volunteers ≠ HNV More family involvement Require more personal attention of P.I. Have more medical questions 15
  16. 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) 16
  17. 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) 17
  18. 18. Beyond PaperUsing data-driven expertise to enhance patient recruitment Jeffrey Zucker, MS Senior Director and Global Head, Patient Recruitment Kendle
  19. 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 success19 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. 20. Components Vendors Internal Feasibility Expertise Patient Medical Regulatory Recruitment Affairs Key Opinion Marketing Leaders Investigator Consult20 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. 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 strategies21 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. 22. Internal resource Medical AffairsMedical 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 access22 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. 23. Internal resource MarketingMarketing• 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 companies23 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. 24. Internal resource RegulatoryRegulatory• 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 used24 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. 25. External resourceKOLs and Investigator consult Key Opinion Investigator Leaders Consult• Clinical protocol guidance • Operational guidance• Standard of care • Recruitment issues• Medical trends • Competitive landscape25 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. 26. External resource VendorsVendors• 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 daily26 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
  27. 27. Recruitment simulation Using data to predict success
  28. 28. Timeline modeling 250 patients were enrolled in 16 months or less 50% of the time28 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. 29. Recruitment curve 250 patients were enrolled in 16 months or less 50% of the time29 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. 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 changesRe-run the model with new assumptions30 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. 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 results31 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. 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 results32 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
  33. 33. IRB Considerations in Proof‐of‐Concept Trials Kathy Chase, Pharm.D. Chair, MLIRB
  34. 34. Proof‐of‐Concept Research Study• Proof‐of‐principle / concept study• First time in humans• Target disease state
  35. 35. Basic Elements of IRB Review• Protocol • Informed consent form• Recruiting materials• Safety reports• Ongoing results
  36. 36. Fundamental Responsibility of IRBAssure the rights &welfare of the subject is protected• IRB membership• Review process ▫ Initial review ▫ Ongoing review
  37. 37. IRB EvaluationDrug Product• Experience ▫ Animal studies ▫ In vivo studies ▫ Human studies• Data source
  38. 38. IRB EvaluationResearch Protocol• Objectives/Purpose• Study Design ▫ Risk vs benefit ▫ Healthy vs disease• Subject Selection ▫ Inclusion criteria ▫ Exclusion criteria
  39. 39. IRB EvaluationResearch Protocol• Study Methods/Procedures/Plan ▫ Diagnostic testing ▫ Dose escalation• Adverse Events/Deviations ▫ Definitions ▫ Prescriptive action• Evaluation Methods/Statistical Analysis
  40. 40. IRB EvaluationInformed Consent Form
  41. 41. IRB EvaluationInformed Consent Form• Readability ▫ Eighth grade reading level ▫ Format
  42. 42. IRB EvaluationInformed 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”
  43. 43. IRB EvaluationInformed Consent Form• Description of procedures ▫ Schedule of tests and drug administration ▫ Diagnostic tests ▫ Blood draws Frequency  Amount ▫ Diaries
  44. 44. IRB EvaluationInformed Consent Form• Risks ▫ Animal studies ▫ In vivo studies ▫ Human studies ▫ Similar agents
  45. 45. IRB EvaluationInformed Consent Form• Risks ▫ Pregnancy risks Women Men ▫ Diagnostic test risks ▫ Psychological risks
  46. 46. IRB EvaluationInformed Consent Form• Benefits• Alternative Therapy
  47. 47. IRB EvaluationSubject Recruitment• Vulnerable populations ▫ Children ▫ Prisoners ▫ Chronic disease• Inducement• IRB oversight
  48. 48. Ongoing IRB Actions• Safety analysis• Protocol deviations• Progress reports
  49. 49. IRB EvaluationSafety Reports• Serious adverse events• Report to IRB• IRB actions ▫ Informed consent modifications ▫ Protocol modifications ▫ FDA report• Subject follow up
  50. 50. IRB EvaluationProtocol Deviations• IRB review ▫ Description of deviation ▫ Intended deviation ▫ Unintended deviation• IRB responsibility
  51. 51. IRB EvaluationProgress Report• Frequency of Review• IRB Analysis ▫ Safety ▫ Protocol deviations ▫ Audit results
  52. 52. Questions WebcastQ&A… Thank you for joining us today for our webcast on ‘Perspectives on PatientRecruitment’!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 Chairbvince@vinceandassociates.com Langland MLIRBwww.vinceandassociates.com Quadrant Kathy.Chase@cardinalhealth.com rimmy.junday@langland.co.uk www.mlirb.com www.kendle.com
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