title: Patient recruitment into a multicenter randomized clinical trial for kidney disease: report of the focal segmental glomerulosclerosis clinical trial (FSGS CT).
abstract: We describe the experience of the focal segmental glomerulosclerosis clinical trial (FSGS CT) in the identification and recruitment of participants into the study. This National Institutes of Health funded study, a multicenter, open-label, randomized comparison of cyclosporine versus oral dexamethasone pulses plus mycophenolate mofetil, experienced difficulty and delays meeting enrollment goals. These problems occurred despite the support of patient advocacy groups and aggressive recruitment strategies. Multiple barriers were identified including: (1) inaccurate estimates of the number of potential incident FSGS patients at participating centers; (2) delays in securing one of the test agents; (3) prolonged time between IRB approval and execution of a subcontract (mean 7.5 ± 0.8 months); (4) prolonged time between IRB approval and enrollment of the first patient at participating sites (mean 19.6 ± 1.4 months); and (5) reorganization of clinical coordinating core infrastructure to align resources with enrollment. A Web-based anonymous survey of site investigators revealed site-related barriers to patient recruitment. The value of a variety of recruitment tools was of marginal utility in facilitating patient enrollment. We conclude that improvements in the logistics of study approval and regulatory start-up and testing of promising novel agents are important factors in promoting enrollment into randomized clinical trials in nephrology.
authors: University of North Carolina, Chapel Hill, NC, USA.
authors: Maria
authors: M
authors: Ferris
authors: Victoria
authors: V
authors: Norwood
authors: Milena
authors: M
authors: Radeva
authors: Jennifer J
authors: JJ
authors: Gassman
authors: Amira
authors: A
authors: Al-Uzri
authors: David
authors: D
authors: Askenazi
authors: Tej
authors: T
authors: Matoo
authors: Maury
authors: M
authors: Pinsk
authors: Amita
authors: A
authors: Sharma
authors: William
authors: W
authors: Smoyer
authors: Jenna
authors: J
authors: Stults
authors: Shefali
authors: S
authors: Vyas
authors: Robert
authors: R
authors: Weiss
authors: Debbie
authors: D
authors: Gipson
authors: Frederick
authors: F
authors: Kaskel
authors: Aaron
authors: A
authors: Friedman
authors: Marva
authors: M
authors: Moxey-Mims
authors: Howard
authors: H
authors: Trachtman
mesh_terms: D002675:Child, Preschool; D005843:Geography; D005923:Glomerulosclerosis, Focal Segmental / Q000628:therapy*; D006285:Health Planning; D006306:Health Surveys; D006801:Humans; D015337:Multicenter Studies as Topic; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D058028:Research Report; D014481:United States
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