Interactive financial decision support for clinical research trials.

Abstract

The purpose of this article is to describe a decision support approach useful for evaluating proposals to conduct clinical research trials. Physicians often do not have the time or background to account for all the expenses of a clinical trial. Their evaluation process may be limited and driven by factors that do not indicate the potential for financial losses that a trial may impose. We analyzed clinical trial budget templates used by hospitals, health science centers, research universities, departments of medicine, and medical schools. We compiled a databank of costs and reviewed recent research trials conducted by the Department of Cardiothoracic Surgery in a major academic health science center. We then developed an interactive spreadsheet-based budgetary decision support approach that accounts for clinical trial income and costs. It can be tailored to provide quick and understandable data entry, accurate cost rates per subject, and clear go/no-go signals for the physician.