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. 2013 Feb;6(1):13-20.
doi: 10.1111/cts.12003. Epub 2012 Oct 30.

Patient recruitment into a multicenter randomized clinical trial for kidney disease: report of the focal segmental glomerulosclerosis clinical trial (FSGS CT)

Maria Ferris  1 , Victoria Norwood, Milena Radeva, Jennifer J Gassman, Amira Al-Uzri, David Askenazi, Tej Matoo, Maury Pinsk, Amita Sharma, William Smoyer, Jenna Stults, Shefali Vyas, Robert Weiss, Debbie Gipson, Frederick Kaskel, Aaron Friedman, Marva Moxey-Mims, Howard Trachtman
Affiliations

Patient recruitment into a multicenter randomized clinical trial for kidney disease: report of the focal segmental glomerulosclerosis clinical trial (FSGS CT)

Maria Ferris et al. Clin Transl Sci. 2013 Feb.

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.

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Figures

Figure 1
Figure 1
Number of patients reported to have been seen in years 2001–2002 (projected enrollment) and the number of at PED and IM sites entered into the study (actual enrollment).
Figure 2
Figure 2
Geographical distribution of the patients who were enrolled in the FSGS based on the zip code of the participating site where they were treated.
Figure 3
Figure 3
Timeline of FSGS CT study outlining key events in the set up and performance of the study.
See this image and copyright information in PMC

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