Financial management of a large multisite randomized clinical trial

Alice J. Sheffet, Linda Flaxman, Meelee Tom, Susan E. Hughes, Mary E. Longbottom, Virginia J. Howard, John R. Marler, Thomas G. Brott

Research output: Contribution to journalArticle

4 Scopus citations

Abstract

Background: The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years' funding ($21112866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2500 randomized participants at 40 sites. Aims: Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Methods: Projections of the original grant's fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant's fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Results: Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2500 targeted sample size, 138 (5·5%) were randomized during the first five years and 1387 (55·5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13845) of the projected per-patient costs ($152992) of the fixed model. Conclusions: Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity.

Original languageEnglish (US)
Pages (from-to)811-813
Number of pages3
JournalInternational Journal of Stroke
Volume9
Issue number6
DOIs
StatePublished - Aug 2014

Keywords

  • Carotid endarterectomy
  • Carotid stenting
  • Clinical trial
  • Cost factors
  • Economics
  • Stroke

ASJC Scopus subject areas

  • Neurology

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    Sheffet, A. J., Flaxman, L., Tom, M., Hughes, S. E., Longbottom, M. E., Howard, V. J., Marler, J. R., & Brott, T. G. (2014). Financial management of a large multisite randomized clinical trial. International Journal of Stroke, 9(6), 811-813. https://doi.org/10.1111/ijs.12259