Incremental Costs of Enrolling Cancer Patients in Clinical Trials: a Population-Based Study

Wagner, Judith; Alberts, Steven R.; Sloan, Jeff A.; Cha, Steven; Killian, Jill M.; O’Connell, Michael J.; Grevenhof, P Van; Lindman, Jacob; Chute, Christopher G.

doi:10.1093/jnci/91.10.847

Cited by 84 publications

(43 citation statements)

References 13 publications

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“…To our knowledge to date there have been only a few comparative studies, all published within the last few years, and each has had significant limitations Table 9. Wagner et al 1 reviewed data from the Mayo Clinic Cancer Registry and entered 176 patients with 9 different malignancies into a cost comparison analysis. Matched case-control patients (as defined by patients matched for age Ϯ 7 years, stage of disease, year Ϯ 3 of diagnosis, and potential eligibility for an investigational study) could not be found for 115 of the patients (65%) and these patients subsequently were excluded from the study, leaving 61 pairs of patients in the final analysis.…”

Section: Discussionmentioning

confidence: 99%

“…To our knowledge there have been only a few published studies that have compared the costs (or charges) accrued by patients with cancer who have participated in clinical trials with the costs (or charges) accrued by patients who received standard therapy. [1][2][3] Each of these studies has been difficult to interpret for various reasons. For example, in some studies patients with different tumor types were compared with each other and in other studies, large numbers of patients treated on a protocol were not included in the final financial analysis because suitable patients for comparison could not be found.…”

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confidence: 99%

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Financial analysis of patients with newly diagnosed acute myelogenous leukemia on protocol or standard therapy

Berman

Little

Teschendorf

et al. 2002

Cancer

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BACKGROUNDMedicare and third‐party payers may be reluctant to pay for investigational (protocol) therapy for patients with cancer on the premise that such treatment is more expensive than standard therapy. However, prior studies that have attempted to compare protocol therapy with standard therapy have been difficult to interpret because of the assortment of malignancies studied and the lack of suitable control groups of patients who received standard therapy.METHODSIn the current study, the authors conducted a retrospective review of the financial charges associated with protocol or nonprotocol (standard) chemotherapy in patients with a single malignancy, newly diagnosed acute myelogenous leukemia (AML), who received their initial course of chemotherapy (“induction”) at the Memorial Sloan‐Kettering Cancer Center (MSKCC) between 1996 and 1999. Protocol and nonprotocol groups were analyzed according to clinical characteristics and standard prognostic features to determine whether the two groups were comparable. Median charges for all patients were determined using a database that linked clinical information, financial data, and clinical outcomes.RESULTSA total of 353 patients with newly diagnosed AML were registered at MSKCC during the time period studied; of these, 79 patients (22%) received all of their care at the institution. Thirty patients (38%) received treatment on an investigational protocol. Forty‐nine patients (62%) did not receive protocol therapy for the following reasons: 10 patients (20%) did not meet eligibility criteria, 4 patients (8%) were eligible for protocol therapy but declined, and 35 patients (71%) met protocol criteria but were not offered protocol therapy based on the judgment of their primary oncologist. The groups were not comparable because patients treated with standard therapy were older and had a poorer initial Eastern Cooperative Oncology Group (ECOG) performance status. Overall median charges for patients in the nonprotocol group were higher than for patients treated on a protocol although charges were not related to age, initial ECOG performance status, or cytogenetic risk group.CONCLUSIONSAlthough charges for the nonprotocol group were higher, specific factors responsible for this difference were not identified. This study emphasizes the problems inherent in assembling suitable groups of patients for comparison. Cancer 2002;95:1064–70. © 2002 American Cancer Society.DOI 10.1002/cncr.10805

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

Financial analysis of patients with newly diagnosed acute myelogenous leukemia on protocol or standard therapy

Berman

Little

Teschendorf

et al. 2002

Cancer

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“…Fears of financial implications of entering a patient continue to be a deterrent to trial entry. The additional cost of treating a patient within a trial is only just beginning to be estimated, but may not be as high as feared (Wagner et al, 1999).…”

Section: Discussionmentioning

confidence: 99%

Haematologists' approaches to the management of adolescents and young adults with acute leukaemia

et al. 2000

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Summary. Approaches to the management of adolescents and young adults with acute leukaemia were investigated by sending a questionnaire to hospitals identified as having diagnosed or treated patients aged 15±29 years. The responses demonstrated the types of hospital treating these patients, the haematologists' perceived practice for entry of patients to Medical Research Council (MRC) leukaemia trials and reasons for non-entry. Data were linked to MRC trials data to determine the proportion of patients aged 15± 29 years at diagnosis in responding hospitals actually treated in MRC leukaemia trials in the 5 years preceding the questionnaire. Eighty-two per cent of haematologists stated that they entered patients`always' or`whenever possible' for acute myeloid leukaemia (AML) and 76% for acute lymphoblastic leukaemia (ALL), but actual entry rates from the study hospitals were 46% of 239 AML patients and 36% of 182 ALL patients. The reasons most commonly reported for not entering eligible patients to national leukaemia trials were clinician preference for one arm of an MRC trial, a regional study or non-trial protocol, and concern about workload and ethical approval.

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“…If these technologies are shown to be effective in clinical testing, it would be reasonable to compare economic outcomes to current LVRS. Clinical trials necessarily involve more intensive patient monitoring than typical clinical practice, and the depth of experience of the participating clinical centers also influences economic outcomes (41). A reasonable question is then whether the cost-effectiveness of LVRS as performed in clinical practice compares with the result calculated from the clinical trial.…”

Section: Future Research On the Cost-effectiveness Of Lvrsmentioning

confidence: 99%

Cost-Effectiveness of Lung Volume Reduction Surgery

Ramsey¹,

Sullivan²,

Kaplan³

2008

Proceedings of the American Thoracic Society

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Lung volume reduction surgery (LVRS) is a costly procedure that can improve quality and quantity of life. Given the prevalence of emphysema, the costs involved with its management, and resource constraints on all health care delivery systems, evaluating the costeffectiveness of LVRS is important. In this article, we describe the purposes and principles of cost-effectiveness analysis and how those principles were applied in evaluating LVRS. We present the results of the cost-effectiveness analysis that was conducted alongside the National Emphysema Treatment Trial and other economic studies of LVRS and discuss how these should be interpreted in the context of current reimbursement guidelines.

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Incremental Costs of Enrolling Cancer Patients in Clinical Trials: a Population-Based Study

Abstract: This study suggests that cancer chemotherapy trials may not imply budget-breaking costs. Cancer itself is a high-cost illness. Clinical protocols may add relatively little to that cost.

Cited by 84 publications

References 13 publications

Financial analysis of patients with newly diagnosed acute myelogenous leukemia on protocol or standard therapy

Financial analysis of patients with newly diagnosed acute myelogenous leukemia on protocol or standard therapy

Haematologists' approaches to the management of adolescents and young adults with acute leukaemia

Cost-Effectiveness of Lung Volume Reduction Surgery

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