WASHINGTONAccumulating evidence shows that the additional cost
of treating cancer patients in clinical trials vs that of providing
standard care is essentially negligible, and, in some instances,
treatment on protocol is significantly less expensive, experts said
at a congressional briefing sponsored by the National Coalition for
The briefing was specifically aimed at supporting proposals pending
in the House and Senate that would create a clinical trials
demonstration project to determine the true costs of cancer clinical
trials to the Medicare system. During this project, Medicare would be
required to pay the costs of routine patient care for its
beneficiaries participating in clinical trials, which it does not do now.
There has been some feeling, particularly here on Capitol Hill,
that saying Medicare would support patients entered in clinical
trials would somehow increase the cost. We believe that, in fact, it
would decrease the cost, said Jerome W. Yates, MD, MPH, senior
vice president for clinical affairs at Roswell Park Cancer Institute,
who moderated the session. One of the reasons were
concerned about this is because the insurance carriers tend to follow
the lead of Medicare.
The Congressional Budget Office and the Health Care Financing
Administration (HCFA) estimate that paying patient care costs for
Medicare beneficiaries enrolled in clinical trials would increase the
patients treatment costs by 10% to 20%, said George J. Bosl,
MD, of Memorial Sloan-Kettering Cancer Center. That notion is
based upon data that I cant find, he added. Until
recently, I would say there were very little data that would say anything.
Memorial Sloan-Kettering Study
Dr. Bosl described a soon-to-be-published cost-comparison study
involving 152 matched cancer patients who were treated at Memorial
Sloan-Kettering. Half the patients were enrolled in clinical trials;
the other half received standard care. A cost analysis showed the
average cost of treating the research patients was 20% less: $29,741
per patient for the clinical trials groups vs $37,201 for standard care.
Hospital costs were 23% less for study participants than for
the standard-care patients; professional services, 9% less; inpatient
costs, 27% less; and outpatient costs, 18% less, Dr. Bosl said.
Radiation therapy costs were 25% lower for the clinical trials
patients as were drugs and supplies; operating room costs were 8%
less; and the research patients spent 24% fewer days hospitalized
From the perspective of those of us who have had a chance to
look at our institutional data and are awaiting other data to come
out, clinical trials cost the same or less, Dr. Bosl said.
There is no real reason to expect them to cost more, either in
the Medicare population or in the population at large.
M.D. Anderson Cost Model
Evidence from studies of ovarian, prostate, and lung cancer patients
at the University of Texas M.D. Anderson Cancer Center support Dr.
Bosls statement, said Melinda M. Branch, MPA, the centers
manager for research administration. M.D. Anderson has been
developing a cost model for the past 4 years in an effort to estimate
costs. This model has been validated by reviewing actual patient care
charges for more than 3,000 patients enrolled on standard care
pathways or clinical trials at the Center.
Among the ovarian cancer patients, the average cost for treating
patients enrolled on the clinical trial was $13,802, 35% less than
the $21,130 per patient cost for women enrolled on the standard care
pathway. For lung cancer patients on the clinical trial, it cost an
average of $15,650 per patient, 36% less than the $24,536 average
cost of the standard care pathway treatment. Among prostate cancer
patients, the average cost for the clinical trial was $16,775, only
2% higher than the average cost of $16,478 for the standard care
pathway (Table 2).
Clinical trials are not more costly than standard care,
Ms. Branch said. Often they are less costly because you avoid
having unnecessary treatments and tests, and the clinical drugs are
provided by the sponsors. Clinical trials are ethical and economic
William P. Peters, MD, PhD, director of the Barbara Ann Karmanos
Cancer Institute, Detroit, described findings from studies of breast
and lung cancer patients there. Among the lung cancer group, the
average cost over 6 months for patients on protocol was 93% of the
cost of those receiving the standard treatment. Among breast cancer
patients, the average cost for study participants was 104% that of
the standard care group.
Right now, the Congress is funding the NIH and the NCI
substantially, Dr. Peters said. You can cure all the
animals you want, but until you translate that into the patient and
actually prove the value for the patient, you are wasting your money.
The clinical research portion is critical to the final outcome.
University of Minnesota Results
Dr. Yates also described findings from a study at the University of
Minnesota, led by S.R. Alberts, MD. This case-control comparison
matched 61 patients in clinical trials against those receiving
customary treatment. The mean costs over the first 6 months were
$18,492 for the research patients and $17,427 for those receiving
customary care (P = .84). Although the total dollar average was
higher in clinical trials, statistically there was no
difference, Dr. Yates said.
Two speakers suggested that Medicare was discriminating against its
own beneficiaries by refusing to pay their patient care costs so they
can take part in clinical trials. Failure to allow a patient to
participate in a clinical research study relegates them to
ineffective and outdated care, Dr. Peters said. It is
discriminatory, for example, to elderly patients who are not being
allowed to participate in clinical research studies.
Dr. Yates added: The leadership of the US in medicine has
largely been built on the shoulders of clinical trials. If we are
going to have guidelines to manage patients in the community, we need
to develop the evidence for this. And the evidence comes from