Cost of care for patients enrolled in clinical trials is the same as for standard treatment

July 28, 2000

There is new evidence that the costs associated with participating in a clinical trial are not greater than receiving standard cancer care, according to researchers. These findings support President Clinton's Executive Order announced in June authorizing Medicare to reimburse the costs incurred in clinical trial participation.

The study, conducted for the Association of American Cancer Institutes, found that at five large cancer centers, six months of care for 35 patients enrolled in phase II clinical trials was $57,542 in direct medical charges. Comparatively, charges were $63,721 for 35 patients with similar characteristics and disease who were not being treated in clinical trials.

The concern of physicians and policy makers is that "a major barrier to accruing patients to clinical trials is financial. Only 3% of adult cancer patients participate in clinical trials," says the study leader, Charles Bennett, MD, PhD, of the Robert H. Lurie Comprehensive Cancer Center at Northwestern University and the VA Chicago Healthcare System.

"But if we want to offer the most advanced care, we need patients to enroll in tests of the best therapies," he says. "This research shows insurers have nothing to lose financially, but everything to gain by improving health care."

The study results, first presented in May at the annual meeting of the American Society of Clinical Oncology, represent pilot data from a larger project designed to help inform policy makers of the costs and charges of federally-supported phase I, II, and III cancer clinical trials. This Association of American Cancer Institutes/Northwestern University study will expand to collect timely data on charges from 10 to 15 cancer centers, according to Bennett.

Previous single-institution studies have also shown that costs in and out of trials are about the same, Bennett says, but many private insurers continue to deny coverage for care associated with clinical trials. On a legislative level, only eight states have passed bills that address reimbursement and nationally, draft legislation from the agency that oversees Medicare is not in agreement with the president's order, he added.
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"Evaluating the Financial Impact of Clinical Trials in Oncology: Results From a Pilot Study From the Association of American Cancer Institutes/Northwestern University Clinical Trials Costs and Charges Project;" Charles L. Bennett, MD, et al.; Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL. Vol. 18, No. 15 (August), 2000: pp. 2805-2810.

The Journal of Clinical Oncology is the semi-monthly peer-reviewed journal of the American Society of Clinical Oncology (ASCO), the world's leading professional society representing physicians who treat people with cancer.

Attribution to the Journal of Clinical Oncology is requested in all news coverage.

For the Full Text of Any JCO Article, Contact 212-584-5034 or 703-299-1016.

American Society of Clinical Oncology

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