BACKGROUND: The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years' funding ($21 112 866) 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% ($13 845) of the projected per-patient costs ($152 992) 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.
RCT Entities:
BACKGROUND: The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years' funding ($21 112 866) 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% ($13 845) of the projected per-patient costs ($152 992) 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.
Authors: Thomas G Brott; Robert W Hobson; George Howard; Gary S Roubin; Wayne M Clark; William Brooks; Ariane Mackey; Michael D Hill; Pierre P Leimgruber; Alice J Sheffet; Virginia J Howard; Wesley S Moore; Jenifer H Voeks; L Nelson Hopkins; Donald E Cutlip; David J Cohen; Jeffrey J Popma; Robert D Ferguson; Stanley N Cohen; Joseph L Blackshear; Frank L Silver; J P Mohr; Brajesh K Lal; James F Meschia Journal: N Engl J Med Date: 2010-05-26 Impact factor: 91.245
Authors: Robert W Hobson; Virginia J Howard; Thomas G Brott; George Howard; Gary S Roubin; Robert DG Ferguson Journal: Curr Control Trials Cardiovasc Med Date: 2001-07-13
Authors: Mary E Longbottom; Jamie N Roberts; Meelee Tom; Susan E Hughes; Virginia J Howard; Alice J Sheffet; James F Meschia; Thomas G Brott Journal: Int J Stroke Date: 2012-05-28 Impact factor: 5.266
Authors: A J Sheffet; G Roubin; G Howard; V Howard; W Moore; J F Meschia; R W Hobson; T G Brott Journal: Int J Stroke Date: 2010-02 Impact factor: 5.266
Authors: Guoqiao Wang; Lei Liu; Yan Li; Andrew J Aschenbrenner; Randall J Bateman; Paul Delmar; Lon S Schneider; Richard E Kennedy; Gary R Cutter; Chengjie Xiong Journal: Alzheimers Dement (N Y) Date: 2022-04-05