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Using Patients As Their Own Controls for Cost Evaluation of Phase I Clinical Trials

From the Division of Solid Tumor Oncology, Department of Medicine; Department of Finance; and Department of Biostatistics, Memorial Sloan-Kettering Cancer Center, New York; the Departments of Public Health and Medicine, Cornell University Medical College, New York, NY; and the Divisions of Population Science and Medical Science, Fox Chase Cancer Center, Philadelphia, PA (E.J.S.'s current affiliation).

Address reprint requests to David G. Pfister, MD, Memorial Sloan-Kettering Cancer Center, Division of Solid Tumor Oncology, Box 188, 1275 York Ave, New York, NY 10021; e-mail: pfisterd{at}mskcc.org

PURPOSE: Little is known about the cost of phase I trials in cancer patients compared with that of standard treatments, yet the former is often assumed to be greater than the latter. Our objective was to utilize a new approach, using patients as their own controls, to compare in a pilot study the costs of care for patients on phase I trials with those incurred for standard treatment.

PATIENTS AND METHODS: We retrospectively assessed the direct medical costs (DMCs) of 59 patients participating in one of two phase I trials (TRIAL) in solid tumors conducted at Memorial Hospital (MH): (1) perillyl alcohol, and (2) flavopiridol with paclitaxel. Paired-control DMCs were those accrued by the same patient while receiving standard chemotherapy regimens just before (PRE; n = 41) or after (POST; n = 29) the trial at MH, averaged per day.

RESULTS: For the 41 PRE patients, the median and mean DMCs per day for the clinical trial versus standard treatment were (US $) $123 v $133 and $219 v $267, respectively. For the 29 POST patients, the median and mean DMCs for the clinical trial versus standard treatment were $157 v $152 and $226 v $226, respectively. Using a linear mixed model, there was no significant difference between TRIAL and standard treatment DMCs (P = .54).

CONCLUSION: Using patients as their own controls represents a new, efficient method for evaluating the cost of phase I trials, and it warrants further study. The results of our pilot study do not suggest that phase I trials always cost payers more than standard treatment.

Presented in part at the 36th Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, May 20-23, 2000.

Dr Sherman is the recipient of the 2000 ASCO Fellowship Award for the highest-ranked abstract submitted by a fellow.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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