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Special Populations

  • November 05 2014

Case Study: Special Populations

(Hypertension)

This was an NIH Phase IV program designed to enroll two, 10,000 subject groups within a five year period for a long term (10 year) study. ICTS designed and implemented a patient recruitment program covering 528 sites in the US, Canada, US Virgin Islands and Puerto Rico in six weeks, and were contracted to send 8,000 pre-qualified referrals from the call center to the investigator sites to jump-start the recruitment for this study. In the first six weeks designated as the recruitment period we referred more than 24,000 pre-qualified patients to the investigator sites and the recruitment phase of the protocol was terminated 4 years, 10 months and two weeks ahead of schedule.

  • Sponsor Challenges – Jump Start
    • 8,000 patients needed, 528 sites, US, US Virgin Islands, Puerto Rico
    • 22% African-American (1760) and 7% Hispanic (560) Randomization set-aside
    • Responsible for African-American and Hispanic Recruitment and 50% of total goal
    • African-American population very sensitive to “Tuskegee Issues”
    • Disproportionate number of in-culture investigators and coordinators
  • ICTS Solutions: 9 Month enrollment period established by client
    • Sociologist consultant hired to assist with African-American Issues
    • Focus Groups to test African-American communications
    • In-community enlistment of clergy and health clinics
    • African-American Educational PR and Advertising Programs Developed
    • In-community diet workshops (African-American only)
    • Advertising in specific African-American and Hispanic Media
    • General Advertising, US cities plus Hispanic Advertising for Puerto Rico and some US cities
  • Results:  Over enrolled all populations: 8,024 total patients
    • 1,948 African-American, 693 Hispanic Patients
  • Cost:  $1,825,000  On budget  Ahead of time
  • Cost per Randomized Patient:  $648.20 (African-American), $324.08 (Hispanic)