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Informed Consent

  • November 05 2014

Case Study: Informed Consent

  • Rheumatology, 1 ongoing study, 1 new parallel study
    • Current consent rate at 7% and cost of randomized patient at $1,950
    • Very difficult I/E criteria
    • Educated patient population
    • Poly Pharmacy situation with many qualified candidates, requiring wash-out and discontinuation
    • Many coordinators mailing ICF to patients, not seen in person, as SOP
    • Treatment working – consent rate low
  • ICTS Solutions
    • Educational DVD, Modular Format, ICF Companion
    • Standardize delivery to include information about FMS and the IC process and patient communication
    • Study team participation to increase credibility and decrease cost
    • Professional Host to deliver bulk of message
  • Cost:  $228,000 
  • Cost per randomized patient:  $814   New Study: $316
  • Consent rate increase to 20%, New study maintained a 25% rate