Financial management of a large multisite randomized clinical trial

Area of Science:

• Clinical Trials
• Health Economics
• Cardiovascular Research

Background:

• The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) was funded by the NIH to compare carotid stenting and surgery for stroke prevention.
• The trial aimed to enroll 2500 participants across 40 sites over five years with a budget of $21,112,866.

Purpose of the Study:

• To evaluate the financial transition of the CREST trial budget from a fixed-cost to a variable-cost model.
• To recommend financial management strategies for large-scale clinical trials.

Main Methods:

• Compared fixed-cost budget projections with actual costs under a revised variable-cost model.
• Analyzed annual direct and indirect costs, per-patient costs, and site expenditures for both models.
• Variable-cost model based payments on actual trial enrollment and site/core center expenditures.

Main Results:

• The variable-cost model extended trial funding through a no-cost extension from five to eight years.
• The number of participating randomization sites increased significantly, from 34 to 109.
• Actual per-patient costs in the variable model were 9% of the projected costs in the fixed model, saving substantial funds.

Conclusions:

• Performance-based budgeting conserves funds, enhances compliance, and allows for expansion of trial sites cost-effectively.
• Effective financial management can reduce the costs of large-scale clinical trials without compromising scientific integrity.