Perspectives on Patient Recruitment

Transcription

1 Webcast Perspectives on Patient Recruitment Sponsors:

2 Presenters Moderator: Christiane Truelove Editor in Chief, R&D Directions Speakers: Dr. Bradley Vince, D.O., President and Medical Director, Vince and Associates Clinical Research Jeffrey M. Zucker Senior Director and Global Head, Patient Recruitment, Kendle Kathy Chase, Pharm.D. IRB chair, MidLands IRB; Director, Provider Services, Cardinal Health Pharmacy Solutions

3 Bradley Vince, D.O. President and Medical Director 3

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

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6 Discussion Topics: Overview Finalizing the Protocol Feasibility Recruitment Medical Oversight Retention 6

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 7

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) s, Newsletters FSFV Milestone, Most Randomized Call the PI Confirm Appointments Welcome packets and handholding Physician Referrals Beware 13

14 Special population volunteers HNV Existing medical co-morbidities Require additional medical oversight Concomitant medications AE assessment 14

15 Special population volunteers HNV More family involvement Require more personal attention of P.I. Have more medical questions 15

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 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 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 Expertise Feasibility Regulatory Patient Recruitment Medical Affairs Marketing Investigator Consult Key Opinion Leaders 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 Internal data External data Medical review and engagement Previous trials conducted database/ctms Previous experience with investigators Regulatory and contract timelines Expertise of internal staff and lesson s learned Standard of care for indication and country Competing clinical trials Disease incidence/prevalence Benchmarking/clinical trial intelligence Detailed examination of protocol medical team Identify and engage key opinion leaders as needed Develop relationships with key advocacy/support groups Internal expertise and relationships Site-specific questionnaires Validate assumptions 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 Medical Affairs 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 Leaders Investigator Consult Clinical protocol guidance Standard of care Medical trends Operational guidance Recruitment issues 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

27 Recruitment simulation Using data to predict success

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

33 IRB Considerations in Proof of Concept Trials Kathy Chase, Pharm.D. Chair, MLIRB

34 Proof of Concept Research Study Proof of principle / concept study First time in humans Target disease state

35 Basic Elements of IRB Review Protocol Informed consent form Recruiting materials Safety reports Ongoing results

36 Fundamental Responsibility of IRB Assure the rights &welfare of the subject is protected IRB membership Review process Initial review Ongoing review

37 IRB Evaluation Drug Product Experience Animal studies In vivo studies Human studies Data source

38 IRB Evaluation Research Protocol Objectives/Purpose Study Design Risk vs benefit Healthy vs disease Subject Selection Inclusion criteria Exclusion criteria

39 IRB Evaluation Research Protocol Study Methods/Procedures/Plan Diagnostic testing Dose escalation Adverse Events/Deviations Definitions Prescriptive action Evaluation Methods/Statistical Analysis

40 IRB Evaluation Informed Consent Form

41 IRB Evaluation Informed Consent Form Readability Eighth grade reading level Format

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

43 IRB Evaluation Informed Consent Form Description of procedures Schedule of tests and drug administration Diagnostic tests Blood draws Frequency Amount Diaries

44 IRB Evaluation Informed Consent Form Risks Animal studies In vivo studies Human studies Similar agents

45 IRB Evaluation Informed Consent Form Risks Pregnancy risks Women Men Diagnostic test risks Psychological risks

46 IRB Evaluation Informed Consent Form Benefits Alternative Therapy

47 IRB Evaluation Subject Recruitment Vulnerable populations Children Prisoners Chronic disease Inducement IRB oversight

48 Ongoing IRB Actions Safety analysis Protocol deviations Progress reports

49 IRB Evaluation Safety Reports Serious adverse events Report to IRB IRB actions Informed consent modifications Protocol modifications FDA report Subject follow up

50 IRB Evaluation Protocol Deviations IRB review Description of deviation Intended deviation Unintended deviation IRB responsibility

51 IRB Evaluation Progress Report Frequency of Review IRB Analysis Safety Protocol deviations Audit results

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. President and Medical Director Rimmy Junday Account Manager Langland Quadrant Kathy Chase, Pharm.D. Chair MLIRB