Commentary: The War Against Cancer Needs New Recruits

On May 17, results were released on the largest clinical trial yet comparing standard therapy for advanced breast cancer to a risky treatment involving very high doses of chemotherapy followed by bone marrow transplants. Researchers found no advantage to the more aggressive approach--but that news came too late for the 12,000 U.S. women who have already undergone the ravaging high-dose chemo. Sadly, it took researchers seven years to collect enough data to reach their conclusion--because only 553 women ever enrolled in the trial.

COST FACTOR. The small number highlights the biggest problem facing cancer researchers: the extreme paucity of patients entering clinical trials that underpin treatment decisions. Prostate cancer researchers have had to close down trials that would answer such key questions as whether or not to surgically remove the prostate, because they can't enroll enough patients. In fact, a survey released on May 15 by the American Society of Clinical Oncology (ASCO) found that less than 5% of all U.S. cancer patients take part in clinical trials, even though 20% are eligible.

No one knows why 95% of women who undergo high-dose chemo don't enroll in trials. But the data point to possible reasons. The ASCO survey found that cost was a factor limiting participation in clinical trials. Contrary to expectations, though, it's not because insurers won't pay. While most policies state that clinical trials are not covered, in reality, 95% of patients enrolled in trials do submit claims, less than 10% of which are denied.

The bigger obstacle may be the cost to doctors. Oncologists estimate that they must spend some 200 additional hours on each patient in a clinical trial. That time is hard to come by in today's managed care environment, where doctors are pressured to see ever more patients. It costs doctors on average $2,000 per patient to participate in a trial, and expenses can range as high as $6,500. But the current reimbursement is only $750 per patient from the National Cancer Institute, a government agency that funds about 50% of all trials, and $2,500 from drug companies.

Clearly, more must be done to encourage participation. Patients must be made aware of the advantages--to themselves and to society at large. The Susan G. Komen Breast Cancer Foundation in Dallas, which funds research, is setting the right example--it is about to announce a $200,000 pilot program in seven cities to encourage trial participation. Reimbursements for government trials must also be increased to reflect the costs, and medical groups must guarantee doctors time for research.

The NCI estimates that 8.2 million Americans have cancer, and another 1.2 million cases will be diagnosed this year. But only 20,000 cancer patients are enrolled in clinical trials. Ending that shortfall is a cost society can well afford.