Economic analyses of phase III cooperative cancer group clinical trials

Are they feasible?

Charles L. Bennett, Robert Golub, Teresa Waters, Martin S. Tallman, Jacob M. Rowe

Research output: Contribution to journalArticle

31 Citations (Scopus)

Abstract

Both economic and clinical evaluations of new pharmaceutical agents are important to physicians who practice in the current health care environment. While cooperative cancer groups carry out large-scale phase III clinical evaluations of these agents, few cooperative group studies incorporate economic analyses because of concerns over overburdening of data management, investigators, and statistical center personnel. In this study, we describe the results and operational considerations of one of the first completed economic analyses of a phase III cooperative group trial of the Eastern Cooperative Oncology, Group (ECOG). We developed an economic model estimating economic benefits of yeast-derived granulocyte-macrophage colony-stimulating factor (GM-CSF) as adjunct therapy for adult patients (56-70 years) with acute myelogenous leukemia. Clinical data were based on prospectively collected information from a recently reported double-blind phase III multi- institutional study carried out by ECOG. Retrospective economic data were obtained from financial information systems at our hospital, one of the study sites. The cost-minimization analyses were based on the perspective of a third-party payer. Indirect costs related to loss of earnings by patients and caregivers as well as quality-of-life adjustments were not incorporated into the model. Clinical trial results indicated that patients treated with GM- CSF had shorter times to recovery of absolute neutrophil count of 500 cells/mm 3 and 100 cells/mm 3 and fewer serious infections than patients who received placebo following induction chemotherapy, while not significant differences were noted in red blood cell and platelet transfusion dependency, toxicities, and duration of hospitalization. The economic model estimated that the group treated with GM-CSF was estimated to have lower costs of care, associated with lower frequencies of serious infections and lower overall infection-related costs. Sensitivity analyses indicated that these results held true over a wide range of estimates of costs and infection rates. Prospective economic analyses of phase III cooperative cancer group clinical trials have not been completed to date. Strategies that are not likely to overburden data managers and statistical center personnel are possible to devise. However, these studies require careful planning and coordination between clinical trialists, economists, and health services researchers.

Original languageEnglish (US)
Pages (from-to)227-236
Number of pages10
JournalCancer Investigation
Volume15
Issue number3
DOIs
StatePublished - Jan 1 1997
Externally publishedYes

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Economics
Clinical Trials
Costs and Cost Analysis
Granulocyte-Macrophage Colony-Stimulating Factor
Economic Models
Neoplasms
Infection
Research Personnel
Health Insurance Reimbursement
Erythrocyte Transfusion
Platelet Transfusion
Induction Chemotherapy
Information Systems
Acute Myeloid Leukemia
Caregivers
Health Services
Cost-Benefit Analysis
Hospitalization
Neutrophils
Cell Count

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Economic analyses of phase III cooperative cancer group clinical trials : Are they feasible? / Bennett, Charles L.; Golub, Robert; Waters, Teresa; Tallman, Martin S.; Rowe, Jacob M.

In: Cancer Investigation, Vol. 15, No. 3, 01.01.1997, p. 227-236.

Research output: Contribution to journalArticle

Bennett, Charles L. ; Golub, Robert ; Waters, Teresa ; Tallman, Martin S. ; Rowe, Jacob M. / Economic analyses of phase III cooperative cancer group clinical trials : Are they feasible?. In: Cancer Investigation. 1997 ; Vol. 15, No. 3. pp. 227-236.
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