Key Words

Clinical trials, costs of cancer treatment. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary.)

Summary

The most comprehensive study yet on the issue confirms that there are only slightly higher patient-care costs associated with treating patients in cancer clinical trials compared to treating similar patients outside of trials.

Source

Journal of the American Medical Association, June 11, 2003 (see the journal abstract of the study).

Background

Private health insurers are often reluctant to reimburse for patient care provided as part of a clinical trial. This reluctance is driven in part by a perception that the costs of caring for patients enrolled in trials are substantially higher than the costs of care provided outside of a trial.

Insurers’ unwillingness to cover the costs of care for patients in trials hinders efforts to enroll patients in clinical trials, which are the only way safe and effective new cancer treatments can be established. Fewer than 3 percent of all cancer patients, or about 19,000 people, enrolled in National Cancer Institute-sponsored Phase III clinical trials in 1999.

The Study

Researchers compiled the treatment costs for 932 adult cancer patients who were enrolled between Oct. 1, 1998, and December 31, 1999, in trials sponsored by the National Cancer Institute (NCI). They then compared these costs with those for 696 cancer patients who were treated outside of clinical trials. The nonparticipants were similar to the trial participants in terms of the stage of their disease; they would have been eligible to enroll in a trial but for various reasons did not.

For each patient, treatment costs were calculated for a period averaging 2.5 years from the date of the individual’s cancer diagnosis. Included were doctor visits, hospital stays, diagnostic tests and procedures, and all drugs given in a doctor’s office, hospital outpatient department, or other treatment settings. Patients’ out-of-pocket costs were included as well as costs reimbursed by third-party payers.

Most of the trial participants were enrolled in Phase III treatment trials, which usually involve hundreds of patients and determine the overall benefits and risks of a proposed new cancer treatment. Some were enrolled in earlier phase trials, which involve fewer patients and are conducted to provide initial information about the safety (Phase I) or efficacy (Phase II) of a new cancer treatment. The clinical trials were conducted at academic health centers, private hospitals, doctors’ offices, or oncology practices participating in NCI’s Community Clinical Oncology Program.

Results

After adjusting to account for potentially confounding factors such as how sick patients were when they enrolled in a clinical trial and whether they had received previous treatment for their cancer, the researchers concluded that treatment costs for trial participants were 6.5 percent higher than they would have been if these patients had not enrolled in a trial: $35,418 for trial participants and $33,248 for nonparticipants, a difference the researchers described as modest.

Why were trial participants more expensive to treat? Researchers noted that trial participants received more physician visits, more expensive tests, and more pathology reports compared to nonparticipants. The type of trial was especially relevant here: patients in early phase trials had much higher additional treatment costs than those in Phase III trials. When nonparticipants’ costs were compared only to Phase III trial participants’ costs, the latter was 3.5 percent higher; when compared to Phase I and Phase II treatment costs, the difference was much larger: 12.8 percent.

Patients in early-phase trials tend to be sicker, to receive more aggressive treatment, and to have a greater chance of dying during the trial, the researchers noted. Overall, trial participants who died incurred costs that were about 18 percent higher than those who died outside of a trial, whereas the additional cost of trial participation for patients who survived was small (3.5 percent).

“We hope our findings will reassure health plans and policy makers that the costs of allowing patients to participate in NCI-sponsored clinical trials are minimal,” said Mary S. McCabe, R.N., of the National Cancer Institute and one of the study’s co-authors.

Limitations

Data for the study were collected in 1998 and 1999, before Medicare -- the federal health care program for people aged 65 and over -- began covering the costs of patient care in clinical trials in 2000. If a similar study were done today, the higher proportion of Medicare beneficiaries enrolling in clinical trials might alter the incremental costs of trial participation. Also, the study did not include trials involving children and trials sponsored by pharmaceutical companies.

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