Feasibility Solutions to Clinical Trial Nightmares


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Slow patient recruitment and poor retention cause recurrent nightmares and perpetual problems often resulting in missing recruitment milestones. The cost of these delays represents hundreds of thousands of dollars for drug and device developers. By recognizing this issue, early detailed feasibility can provide planning and contingency solutions that are focused on reducing the impact of delayed recruitment. Furthermore understanding what motivates investigators and patients to actively participate in clinical studies and how patient recruitment strategies and materials can support all stakeholders to complete studies on time are critical aspects of clinical study delivery planning.

During this presentation, an experienced Premier Research feasibility and patient recruitment specialist, reviewed feasibility approaches to address protocol evaluation as well as addressed influences on country selection, site distribution and patient recruitment strategies to provide for more effective clinical trial planning and conduct.

For more information, go to http://www.premier-research.com.

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Feasibility Solutions to Clinical Trial Nightmares

  1. 1. 2 0 1 2 PAT I E N T AC C E S S W E B I N A R S E R I E S Feasibility Solutions to Clinical Trial NightmaresMarch 21, 2012 Presented by Sue Robinson
  2. 2. Sue Robinson  Director of Patient Recruitment  15+ years of global CRO experience  Key experience covers: – In-depth global feasibility – Strategic patient recruitment and retention planning – All phases and across a broad range of therapeutic areas2012 PATIENT ACCESS WEBINAR SERIES
  3. 3. What keeps Project Managers up at night?3 2012 PATIENT ACCESS WEBINAR SERIES
  4. 4. How can feasibility help?4 Early, detailed feasibility can provide solutions to all these nightmares! BUT….. More commonly in our industry, we rely on feasibility conducted during the 10 day proposal process to provide the strategy and planning for multi million dollar studies and programs! 2012 PATIENT ACCESS WEBINAR SERIES
  5. 5. It’s never too soon for feasibility for…..5 Protocol development Country & site strategy Recruitment planning 2012 PATIENT ACCESS WEBINAR SERIES
  6. 6. Protocol Development6 Patient Placebo Washout assessments Specialist control periods equipment tools Too Complex Invasive procedures many diary visits data 2012 PATIENT ACCESS WEBINAR SERIES
  7. 7. Avoid Protocol Rejection/Amendments7 1 Justify study design 2 Explain rescue medication and patient evaluation in detail 3 Match protocol with standard of care 4 Take care when including labs for pediatrics 5 Consider that patients have a life outside of the study 2012 PATIENT ACCESS WEBINAR SERIES
  8. 8. Successful Strategy Development8 Sponsor Requirements Investigator & Patient Protocol Motivation Design Competing Country Trial and Site Patient Population Environment Distribution Previous Regulatory Study Environment Data and Disease Timelines Prevalence 2012 PATIENT ACCESS WEBINAR SERIES
  9. 9. Investigator and Patient Motivation9 What are the motivations to join a study? Investigators Patients 1) Scientific interest/recognition/ 1) Access to relief of symptoms publication etc. 2) Long term treatment of illness 2) Benefit of better treatment 3) Regular check ups and contact options for patients with medical staff (TLC) 4) Reduced treatment or clinic 3) Lower costs of treatment for attendance costs site and/or patients 5) Education and information 4) Appropriate fee about their condition/study/ treatment options 5) Funds for improved 6) Meeting others with same equipment/ facilities illness 2012 PATIENT ACCESS WEBINAR SERIES
  10. 10. Recruitment Planning10 Know you target Balance Identify the ideal patient recruitment time site profile with site numbers population and distribution Data collection is key 2012 PATIENT ACCESS WEBINAR SERIES
  11. 11. Questionnaire Lottery11 Feasibility data isn’t just about estimated recruitment rates from investigators 2012 PATIENT ACCESS WEBINAR SERIES
  12. 12. The Patient Funnel12 RA patients who haven’t had biological therapy in last 3 months Do you have a database of RA patients? If yes, how many on your database? # of RA patients seen per month % treated with biological therapy # biological therapy failures per month # newly diagnosed RA pts seen per month Target pt pool 2012 PATIENT ACCESS WEBINAR SERIES
  13. 13. The Patient Funnel isn’t the Complete Story…13 Other influences include: Phase and Complexity of Investigator Patient recruitment study design study protocol grant approaches Reimbursement Investigator/ Access to for equivalent Competing assessments studies site staff treatment and motivation assessment 2012 PATIENT ACCESS WEBINAR SERIES
  14. 14. Feasibility in Practice: A Case Study14  Phase 2, placebo controlled study  Requiring ~800 FI patients with minimal scar tissue with moderate to severe FI symptoms Feasibility: Protocol Site 6 weeks update: identification: (+2 weeks KOLs) 4 weeks 4 weeks 2012 PATIENT ACCESS WEBINAR SERIES
  15. 15. Feasibility Summary15  Data from 104 sites Interested sites 8 in 21 countries globally 7  Highest level of interest 6 found in Europe 5 4  Diverse range of physicians 3 and healthcare professionals 2 see these patients 1  Limited previous study activity 0 mainly in devices, injectables and nerve stimulation  Many patients are not actively treated in the sites, many are in other institutions, healthcare facilities or in many cases not seeking medical advice but self medicating 2012 PATIENT ACCESS WEBINAR SERIES
  16. 16. Protocol Updates following Feasibility16 Change of FI assessment score Reduced patient numbers Reduced post screening Patient evaluation run in period procedure modified Modification to Refined diary data extended first visit to be collected 2012 PATIENT ACCESS WEBINAR SERIES
  17. 17. Country Selection17  Five regions assessed but low interest from AP & LA  Countries selected based on level of Regional % Split of Patients interest and recruitment potential 19% North America 29% Western Europe  Main response from WE & CEE  US included for marketing purposes 52% Central and Eastern Europe  Recruitment expected to be higher in CEE based on feasibility results  Majority of sites confirm they would need outreach/advertising to support recruitment 2012 PATIENT ACCESS WEBINAR SERIES
  18. 18. Build Patient Recruitment Strategy on Feasibility Data and Local Knowledge18 40 30 20 10 0 Gastroenterologists are the ideal site but many others see these patients 2012 PATIENT ACCESS WEBINAR SERIES
  19. 19. Build Patient Recruitment Strategy on Feasibility Data and Local Knowledge19 100% 80% 60% 40% 20% 0% CEE NA WE Lack of patients Not interested Study design Lack of resources Competing study Main reason for declining is lack of patients... ...but could sites be interested with supported outreach and referral 2012 PATIENT ACCESS WEBINAR SERIES
  20. 20. Understand the FI Patient Flow20 Patient seeks Primary Physical exam help for confirms FI with Surgeon symptoms of FI Care MD rectal damage Geriatric/ Physical exam Community confirms FI without rectal damage Care Gastroenter- Surgery ologist/ Gynaecology Biofeedback/ Nerve Maintenance stimulation/ therapy/care Bowel training Pharmacy/ Internet – self medication Adequate response 2012 PATIENT ACCESS WEBINAR SERIES Inadequate response
  21. 21. Patient Recruitment Challenges Identified21  A topic not openly discussed – quite frankly it’s embarrassing  Our patient population is hidden – only 1 in 8 present  Practicalities of travelling to sites for visits – limited reach of patient catchment area  Overcoming specific hurdles of protocol at the crucial consent stage  Intrusive exams  Treatment free run-in period  Long first treatment visit in clinic  Placebo controlled study  Significant portion of population potentially excluded due to presence of cardiovascular conditions 2012 PATIENT ACCESS WEBINAR SERIES
  22. 22. Proposed 3 Tiered Approach to Material Development22 Essential Identity, tools for site, direct to patient Items outreach and referral Targeted Press/radio advertising in Media selected countries, washroom advertising, website and targeted mailing kit Campaign Mini protocol, pre screen checklist, visual informed consent guide, patient brochure, Nice to Have conversation guide, print advertorial, banner advertisement, referral fact card & loyalty and retention items 2012 PATIENT ACCESS WEBINAR SERIES
  23. 23. Summary23 Protocol development Country & site strategy Recruitment planning 2012 PATIENT ACCESS WEBINAR SERIES
  24. 24. No more nightmares… feasibility can lead to much sweeter dreams…2012 PATIENT ACCESS WEBINAR SERIES
  25. 25. Upcoming Webinars25 Register at www.premier-research.com/webinars ▪ Optimizing Patient Recruitment in Traditional Markets 18 April at 10:00 am EDT Speaker: Krista Armstrong, Ph.D. ▪ Leveraging Russia and Ukraine for Patient Recruitment 23 May at 10:00 am EDT Speakers: Elena Ulyanets, MD and Marina Deniskova, MD 2012 PATIENT ACCESS WEBINAR SERIES
  26. 26. Questions? Sue Robinson Director of Patient Recruitment Email: sue.robinson@premier-research.com Phone: +44 (0)118 936 4037 www.premier-research.com2012 PATIENT ACCESS WEBINAR SERIES