"If we want to advance patient care, then we have got to have patients enrolled in clinical trials," says study co-author Charles Bennett, M.D., of the Robert H. Lurie Comprehensive Cancer Center at Northwestern University and the VA Chicago Healthcare System. "Our study says we can make those discoveries at no extra cost to insurers."

The study, which was conducted for the American Association of Cancer Institutes, found that at five large cancer centers, total direct medical charges for six months of routine patient care for 35 patients enrolled in phase II clinical trials averaged $57,542 per patient. That compares to an average of $63,721 per patient among 35 patients with similar diseases and characteristics who were not enrolled in clinical trials.

A clinical trial is a study conducted with patients, usually to evaluate new treatments and new ways of preventing disease or symptoms. Clinical trials compare the best known standard therapy to a new therapy to see if one is more effective and causes fewer side effects. These studies may evaluate new drugs, new forms of radiation therapy or new surgical procedures. Some clinical trails study new ways of combining two or more treatments that are already available.

New treatments must prove to be safe and effective in scientific studies with a certain number of patients before they can be made widely available.

According to the researchers, clinical trials often are not reimbursed by Medicare or private insurers, due mainly to concerns that the cost of caring for a patient in a clinical trial is much higher than the cost of standard care.

Dr. Bennett says this study is the first to look at multiple cancer treatment centers but similar results have been reported by Kaiser Permanente, Group Health and the Mayo Clinic. All this research contributes to a growing body of evidence that suggests costs are comparable for the care of cancer patients in and out of clinical trials.

Right now, no consistent policy exists regarding federal or private reimbursement for participation in clinical trials, although Congress is slated to consider such a proposal through the Patients? Bill of Rights and the Medicare Cancer Clinical Trials Coverage Act.

Harmon Eyre, M.D., chief medical officer for the American Cancer Society (ACS), says the Society has set the enactment of a Patient?s Bill of Rights ? with strong, comprehensive protection for all patients in managed care plans ? as one of its top legislative priorities for this congressional session. "One of the key provisions for which we are advocating is access to clinical trials to ensure that cancer patients get the quality care they need," he says.

More than 1.2 million Americans will be newly diagnosed with cancer this year, yet only 3 percent of cancer patients currently participate in cancer clinical trials. For many cancer patients, new treatments that result from high-quality, peer-reviewed clinical trials offer the best hope for survival and improved quality of life, according to the ACS government relations office.

For example, death rates for children with all cancers have decreased by 62 percent since 1960. According to the ACS advocacy office, this improved survival can be linked to the fact that from 70 percent to 90 percent of all children with cancer are treated in clinical trials.