Budget negotiation for industry-sponsored clinical trials.

Abstract

The specialty of anesthesia is well suited to attract industry-sponsored clinical trials and research revenues because of its fundamental contributions to surgery, critical care, and pain medicine. However, the performance and budgeting of industry-sponsored clinical research over the past decade has been significantly altered by the rapid growth of commercially oriented networks of contract-research organizations and site-management organizations. Further, the competitive nature of today's clinical research climate can make the planning and negotiating of study budgets and contracts stressful, time consuming, frustrating, and full of pitfalls. Because a clinical trial contract is a fixed-price agreement, investigators are obligated to perform the work described in the contract, even if the actual costs exceed the study contract. Successful budgeting for the performance of an industry-sponsored clinical trial thus requires a thorough understanding of the direct and indirect costs associated with performing clinical research. We reviewed budget and contractual considerations for the successful negotiation and performance of industry-sponsored clinical research.