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Clinical trial participation does not increase the cost of routine care

The reluctance of insurers to pay for the routine care costs of clinical trial participants (so-called investigational or experimental therapies) is based on the assumption that these costs are substantially higher than they would have been if the patient had not been enrolled in a research study. This is not the case, according to a recent study supported in part by the Agency for Healthcare Research and Quality (HS08362).

Researchers from the Stanford University School of Medicine, the University of Washington School of Medicine, and the Henry Ford Hospital in Detroit compared care costs for total initial hospitalization of heart attack patients enrolled in a clinical trial and similar patients not participating in a trial. They analyzed data from the Myocardial Infarction Triage and Intervention Trial and Registry (1988 to 1991) and the registry of all patients admitted to 19 Seattle area coronary care units (1988 to 1993).

The trial group consisted of 264 patients who received thrombolytics (clot-busting medications) and had available cost data. The 335 patients in the control group met the clinical criteria for trial entry but were not enrolled; they received thrombolytics and had available cost data. Total hospital cost was not significantly different between trial patients (median $11,516) and control patients (median $14,200), leading investigators to conclude that participation in the trial had an insignificant effect on the cost of routine care.

Significant predictors of cost included hospital of admission, length of stay, and coronary revascularization procedures. The authors point out that additional trial-related laboratory tests or ancillary procedures are small ticket items that are unlikely to have a major effect on the overall cost of care. Also, the cost of the intervention studied, in this case a medication, is usually borne by the sponsor, lowering the cost of care for the trial group.

See "Does enrollment in a randomized clinical trial lead to a higher cost of routine care?" by J. Peter Weiss, M.D., M.S., Lori S. Parsons, B.S., Nathan R. Every, M.D., M.P.H., and others, in the January 2002 American Heart Journal 143, pp. 140-144.

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