Using patients as their own controls for cost evaluation of phase I clinical trials Journal Article
| Authors: | Sherman, E. J.; Rubin, D. M.; Venkatraman, E.; Schwartz, G. K.; Miller, V. A.; Radzyner, M. H.; Ruchlin, H. S.; Spriggs, D.; Pfister, D. G. |
| Article Title: | Using patients as their own controls for cost evaluation of phase I clinical trials |
| Abstract: | 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. © 2004 by American Society of Clinical Oncology. |
| Keywords: | adult; controlled study; aged; middle aged; retrospective studies; major clinical study; clinical trial; patient selection; solid tumor; united states; paclitaxel; cancer patient; comparative study; chemotherapy; neoplasm; neoplasms; controlled clinical trial; practice guideline; retrospective study; drug cost; health care cost; economics; cancer center; pilot study; pilot projects; cancer care facilities; flavopiridol; phase 1 clinical trial; health care costs; hospital cost; cost benefit analysis; hospital costs; clinical trials, phase i; humans; human; male; female; priority journal; article; perillyl alcohol; minnesota |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 22 |
| Issue: | 7 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 2004-04-01 |
| Start Page: | 1308 |
| End Page: | 1314 |
| Language: | English |
| DOI: | 10.1200/jco.2004.06.118 |
| PROVIDER: | scopus |
| PUBMED: | 15051779 |
| DOI/URL: | |
| Notes: | J. Clin. Oncol. -- Cited By (since 1996):1 -- Export Date: 16 June 2014 -- CODEN: JCOND -- Source: Scopus |
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