title: The cost-benefit of a randomized trial to a health care organization.
abstract: Clinicians and patients make many decisions in situations where optimal treatment is uncertain. Despite well-published advantages of clinical trials for reducing such uncertainties, a trial may not be conducted because the sample size indicated by classical, hypothesis-testing methods is so large that no one institution could afford to sponsor the trial. By explicitly taking into consideration the costs and benefits of a trial, Bayesian statistical methods permit estimation of the value to a health care organization conducting a randomized trial instead of continuing to treat patients in the absence of more information. This paper describes a method for calculating the cost-benefit to a health care organization conducting a clinical trial, and the expected sample size to adequately resolve the uncertainties about which treatment is better. The method is illustrated in the case of a proposed clinical trial of a drug to prevent multiorgan system failure and death in patients admitted to the Stanford University surgical intensive care unit. This method should permit health care organizations to evaluate a proposed trial's expected cost-benefit and the expected sample size that will resolve the question of interest, and thereby assist in the process of deciding whether to conduct the trial.
authors.affiliation: Department of Health Research and Policy, Stanford University School of Medicine, CA 94305-5092, USA.
authors.forename: J
authors.initials: J
authors.lastname: Hornberger
authors.forename: P
authors.initials: P
authors.lastname: Eghtesady
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use; D003362:Cost-Benefit Analysis; D003422:Critical Care / Q000191:economics; D003622:Dapsone / Q000009:adverse effects / Q000627:therapeutic use; D003661:Decision Support Techniques; D005260:Female; D005102:Health Expenditures / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008329:Managed Care Programs / Q000191:economics*; D008875:Middle Aged; D011183:Postoperative Complications / Q000188:drug therapy / Q000209:etiology; D016032:Randomized Controlled Trials as Topic / Q000191:economics*; D018401:Sample Size; D018746:Systemic Inflammatory Response Syndrome / Q000188:drug therapy / Q000209:etiology
chemical_list: D000890:Anti-Infective Agents; D003622:Dapsone