Chris Trizna CSSi Recruiting Patients - Driving Enrollment - Across The Globe

Transcription

1 Chris Trizna CSSi Recruiting Patients - Driving Enrollment - Across The Globe

2 Planning for Success Enrollment planning takes analysis, collaboration, and preparation to set your study up for success.

3 Today s Goals Understand the Patient Recruitment Outsourcing Landscape Show steps necessary to set study up for successful enrollment Understand the enrollment challenges How to identify the best recruitment tactics through the patient pathway Enrollment planning: appropriate budgets, timelines and contingency planning Scoring to use metrics to make informed decisions and adapt strategies Teamwork across stakeholders to implement effective enrollment planning

4 Current Landscape 86% of clinical trials will experience delays* 94% of trials are delayed by over 1 month* Every study needs recruitment planning Studies lack effective tools and support services Studies lack sufficient recruitment budgets You need the right sites *NG Pharma s Evaluating Challenges to Clinical Trial Execution

5 Outsourcing Fact and Fiction Centralized patient recruitment is expensive It can be, if done incorrectly Patient recruitment is all advertising Every patient is recruited into a study, including private practice All recruitment companies are the same Some focus on media, others on digital, outreach, and site performance The CRO can do the recruitment Many have people in their recruitment department but few are set up like a full service recruitment company & outsource recruitment

6 Patient Recruitment Outsourcing Creative Development Television, Radio, Materials, Websites Call Center Call Screening, referral support Media Placement Television, Radio, Newspaper, Online Full Service All the above Contract Types Pay for Service Pay for Performance/Risk Based Pricing

7 Recruitment or Site Performance? Site Enrollment Performance Source: Tufts CSDD 2011 Fail to Enroll a Single Patient, 11% Meet Enrollment Targets, 39% Under Enroll, 37% Well Exceed Enrollment Targets, 13%

8 Enrollment planning starts with the Patient Why would a patient participate in your trial? What is going to motivate them participate? Is your study design easy for patients to participate? Where are you going to find them? Who are they?

9 Understanding the patient Benefits of Patient Feasibility Increases understanding of patient perceptions of clinical research Assesses viability of protocol design Data driven approach to branding/concept design Increases understanding of how study requirements affect willingness to participate Identifies key actions to augment attractiveness of the study Identifies potential challenges and barriers to patient recruitment and enrollment What is Patient Feasibility? A quantitative process to identify variables impacting an individual s willingness to participate in clinical research Provides information to create data driven recruitment and enrollment strategies How does Patient Feasibility work? Cross-sectional online survey Targets special population at hand (minorities)

10 Who is our target audience? Let s first look into the ideal patient Where is the prevalence? Age and gender Are there caregivers? Who influences the clinical trial participation decision?

11 Patient Pathway Every patient will have a pathway that they follow as they manage their condition. Identify the pathway for these target patients to know where to find them and what tools are needed. Medical Community In Office Other specialist Imaging Centers Family Doctor Physical Therapist Pharmacist Local Community Recreation Centers Health-related events (5K walk/runs, health fairs) Faith based organizations Civic organizations Local arthritis chapters Media Options Television Radio Newspaper Internet Social Media

12 Patient Pathway Medical Path Rheumatologist Family Practice Dermatologist Pharmacist Nurse Educators Physical Therapist Source:

13 Site Selection - Feasibility Based on the patient, what type of sites do you need? How many? Are there competitive studies looking for the same patient? Do they have access to the patient? Difficult patient population and I/E Criteria? Payments are you competitive? Site Performance What do they need to be successful? Performance escalation process Contingency plan: when do you drop/add sites?

14 Historic Results with Similar Studies Similar study results timelines? What worked, what didn t? What were the costs to enroll patients: Stipends competitive? Enrollment costs from advertising?

15 $2,000 $1,800 $1,600 $1,400 $1,200 $1,000 $800 $600 $400 $200 $- Ask about Metrics Study 1 Study 2 Study 3 Study 4 TV Radio Internet

16 How did they enroll? 3% Enrollment Source 9% 29% 59% In Office Referral Source Advertising Other

17 As a Sponsor You need to do your Part sites are small businesses and many lack the expertise and resources needed Professional Support services Develop Tools Support Tactics Timelines

18 Setting your sites up for success Develop tools for sites to use: In their office Within their community (medical and public) Advertising Provide a reasonable recruitment budget Provide support services to sites Advertising Community outreach Site Support On-site support

19 Recruitment Planning: Working Inside-Out Where will you find study participants? (Patient Pathway) In their office? From the community? Through advertising?

20 Recruitment Tactics & Tools In office Pre-identify In office awareness Dr. to Patient letters Letters Protocol presentation Banners Brochures Flyers IE criteria cards Study info sheets Referral cards

21 Recruitment Tactics & Tools Community Outreach Community Events (5K runs/walks, local chapters, high frequency places) Medical Referral Networks (Doctors, specialists, pharmacist, nutritionist, physical therapist, etc.) Tools Letters Brochures Banners Flyers Study info sheets Referral cards

22 Recruitment Tactics & Tools Outsource: Media Vendor/Recruitment Company Advertising (how much?) Traditional Media Television Radio Newspaper Online (need website) Social Search Engines Non Traditional Transit Billboards

23 Creative Development Graphic Designer/Patient Recruitment Company Your tools need to. Create Awareness - Capture your target audience s attention Educate provide some information Get a Response Call, fill out a form online, or ask the doctor

24 Creative Development Graphic Designer/Patient Recruitment Company OR

25 Study analysis & recommendations Pacing and Timing of Each Initiative Pre Study -patient Identification Site Awareness Referring Network Patient Awareness Internet Recruitment External Recruitment Enrollment Analysis (weekly) Week 0 Week 4 Week 8 Week 12

26 Site Performance Following enrollment plan? Referral Processing? Open communication Metrics Recruitment Metrics Which tactics are working? Which are not working In office? Community outreach? Advertising? Patient feedback How do the patients feel about the study? Drop out rate/compliance Timelines and Goals At what point to you take alternative action? What are the contingency costs?

27 Outsourcing Solutions What recruitment services do you need to outsource? Traditional advertising agency Digital advertising experience Creative design Call handling Collecting metrics and reporting Referral support Communications Retention Services? What role will they play and for how long?

28 Thank you for your attendance and participation. Chris Trizna, President