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Feasibility Solutions to Clinical Trial Nightmares


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Presented by Sue Robinson, Premier Research at the ICR Symposium - Finders Keepers: Novel Patient Recruitment & Retention Strategies, November 2011

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Feasibility Solutions to Clinical Trial Nightmares

  1. 1. Feasibility Solutions toClinical Trial Nightmares Sue Robinson Director, Patient Recruitment 1: 28/11/2011
  2. 2. What do our Project Managers dream about? Low investigator Protocol rejection acceptance Slow start up Poor recruitment 2: 28/11/2011
  3. 3. How can feasibility help? 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! 3: 28/11/2011
  4. 4. It’s never too soon for feasibility for….. Protocol Development Country & site strategy Recruitment planning 4: 28/11/2011
  5. 5. Protocol development  Placebo control  Washout periods  Patient assessments tools  Specialist equipment  Invasive procedures  Too many visits  Complex diary data 5: 28/11/2011
  6. 6. Avoid protocol rejection / amendments  Justify study design  Explain rescue medication and patient evaluation in detail  Match protocol with standard of care o Assess investigator common practice for diagnosis, treatment and long term evaluation  Take care when including labs for paediatrics  Consider that patients have a life outside of the study 6: 28/11/2011
  7. 7. Successful strategy development includes Investigator & Patient Sponsor Protocol Motivation Requirements Design Competing Trial Country & site Patient Environment distribution Population Regulatory Previous study Disease Environment Data Prevalence and Timelines 7: 28/11/2011
  8. 8. Investigator and patient motivation What motivates..... Investigators Patients join a study 1. Access to relief of symptoms 1. Scientific 2. Long term treatment of illness interest/recognition/publication etc. 3. Regular check ups and contact with 2. Benefit of better treatment options medical staff (TLC) for patients 4. Reduced treatment or clinic 3. Lower costs of treatment for site attendance costs and/or patients 5. Education and information about 4. Appropriate fee their condition/study/treatment 5. Funds for improved equipment/ options facilities 6. Meeting others with same illness 8: 28/11/2011
  9. 9. Recruitment planning Identify the ideal site profile Balance recruitment time with site numbers and distribution Know your target patient population Data collection is key 9: 28/11/2011
  10. 10. Questionnaire lottery Feasibility data isn’t just about estimated recruitment rates from investigators 10: 28/11/2011
  11. 11. RA patients who haven’t hadThe patient funnel 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 11: 28/11/2011
  12. 12. The patient funnel isn’t the complete story… Patient Phase and recruitment study design approaches Complexity of Investigator study protocol Other grant influences include: Access to Competing assessments studies Reimbursement for Investigator/ site staff equivalent treatment motivation and assessment 12: 28/11/2011
  13. 13. Feasibility in practice – A case study 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 Case Study: FI 13: 28/11/2011
  14. 14. Feasibility summary Interested sites 7 Data from 104 sites in 21 countries 6 globally 5 Highest level of interest found in 4 Europe 3 Diverse range of physicians and 2 healthcare professionals see these 1 patients 0 Finland Belgium Australia Bulgaria Hungary Mexico France Poland Czech Repubilc Russia Austria Norway Italy Spain Netherlands New Zealand Germany Argentina USA Sweden UK Limited previous study activity 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 Case Study: FI 14: 28/11/2011
  15. 15. Protocol updates following feasibility Change of FI assessment Reduced patient score numbers Reduced post screening Patient evaluation run in period procedure modified Modification to extended Refined diary data to be first visit collected Case Study: FI 15: 28/11/2011
  16. 16. Country selection ▪ Five regions assessed but low Regional % split of patients interest from AP & LA ▪ Countries selected based on level of interest and recruitment potential 19% 29% ▪ Main response from WE & CEE ▪ US included for marketing purposes 52% ▪ Recruitment expected to be higher in CEE based on feasibility results ▪ Majority of sites confirm they would WE CEE NA need outreach/advertising to support recruitment Case Study: FI 16: 28/11/2011
  17. 17. Build patient recruitment strategy on feasibilitydata and local knowledge Gastroenterologists are the ideal site but many others see these patients Main reason for declining = lack of patients... ...but could sites be interested with supported outreach and referral Case Study: FI 17: 28/11/2011
  18. 18. Understand the FI patient flow Case Study: FI 18: 28/11/2011
  19. 19. Patient recruitment challenges identified 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 Case Study: FI 19: 28/11/2011
  20. 20. Proposed 3 tiered approach to material development Identity, tools for site, direct to patient outreach Essential items & referral Press/radio advertising in selected countries, Targeted Media washroom advertising, website and targeted campaign mailing kit 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 Case Study: FI 20: 28/11/2011
  21. 21. No more nightmares…feasibility can lead tomuch sweeter dreams… 21: 28/11/2011