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Anesth Analg 2004;99:173-176
© 2004 International Anesthesia Research Society
doi: 10.1213/01.ANE.0000122633.97424.76

ECONOMICS, EDUCATION, AND HEALTH SYSTEMS RESEARCH

Budget Negotiation for Industry-Sponsored Clinical Trials

Kristy Beal*, Juliette Dean, RN CCRC*, James Chen, RN*, Elena Dragaon, RN*, Ann Saulino, RN*, and Charles D. Collard, MD*,{dagger}

*Division of Cardiovascular Anesthesiology, Texas Heart® Institute, St Luke’s Episcopal Hospital; and {dagger}Department of Anesthesiology, University of Texas Health Science Center and Baylor College of Medicine, Houston, Texas

Address correspondence and reprint requests to Charles D. Collard, MD, Clinical Associate Professor of Anesthesiology, Division of Cardiovascular Anesthesiology, Texas Heart® Institute, St Luke’s Episcopal Hospital, 6720 Bertner Ave., Houston, TX 77030. Address e-mail to ccollard{at}heart.thi.tmc.edu

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.

IMPLICATIONS: 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. 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.






Lippincott, Williams & Wilkins Anesthesia & Analgesia® is published for the International Anesthesia Research Society® by Lippincott Williams & Wilkins with the assistance of Stanford University Libraries' HighWire Press®. Copyright 2006 by the International Anesthesia Research Society. Online ISSN: 1526-7598   Print ISSN: 0003-2999 HighWire Press
Copyright © 2004 by the International Anesthesia Research Society.