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Rare Diseases & Disorders

DAC’s clinical research background lends itself to effectively managing educational programs for rare diseases and disorders. We understand the importance of creating and maintaining support and engagement among the research centers as well as leveraging the active advocacy communities. DAC has implemented and managed 14 rare disease programs supporting more than 1,700 research centers across 48 countries.

Success Story: Acne Vulgaris with G6PD Enzyme Deficiency Recruitment Program

Study Details

  • Phase IV, double-blind, randomized, cross-over study with 2-week washout period
  • Target population: G6PD-deficient subjects age 12 or older of African-American and Mediterranean descent with acne vulgaris
  • Recruitment timeline: 4 months

DAC Objectives

  • Generate study awareness through a variety of within-practice and external campaigns
  • Facilitate enrollment of 60 G6PD-deficient subjects with acne vulgaris across 30 sites in North America within 4 months

Campaign

  • Site Support Materials (Recruitment Kits)
  • Advertising (Radio and Print)
  • Monthly Site Newsletters
  • Coordinator Appreciation Packages
  • Patient Support Kits
  • Outreach
  • Call Center Support
  • Enrollment Updates and Tips to Sites

The initiatives were designed to enhance study visibility and promote recruitment enthusiasm among sites and CRAs. Many strategies were directed at facilitating awareness of the study within each site’s own practice. Direct outreach activities, combined with newsletters, weekly recruitment tips and coordinator appreciation packages, contributed to attainment of the enrollment goal. DAC also attributes program success to strong site relationships.

Results

  • 64 patients were randomized by 03/31/2006 due to joint efforts among the sponsor, participating sites and DAC.
  • DAC initiatives were sustained throughout the program.
  • There was steady enrollment progression through the course of the trial—the cumulative result of recruitment support implementation and the level of site activation.