Hostname: page-component-cd9895bd7-7cvxr Total loading time: 0 Render date: 2024-12-25T05:26:45.404Z Has data issue: false hasContentIssue false
  • English
  • Français

Economic Evaluation Alongside Multinational Clinical Trials: Study Considerations for GUSTO iib

Published online by Cambridge University Press:  10 March 2009

Bengt Jönsson  and
Milton C. Weinstein
Bengt Jönsson
Affiliation:
Stockholm School of Economics
Milton C. Weinstein
Affiliation:
Harvard School of Public Health
Get access Rights & Permissions [Opens in a new window]

Abstract

Data relevant to economic evaluation are being collected alongside clinical trials with increasing frequency. When these trials involve health outcomes and resource utilization in many different countries, numerous methodologic problems arise. This paper describes and discusses the methodology for economic evaluation that will be used in the Economic Substudy of GUSTO llb, as an example of how to address the problems that arise in economic evaluations linked to international trials.

Type
General Essays
Information
International Journal of Technology Assessment in Health Care , Volume 13 , Issue 1 , Winter 1997 , pp. 49 - 58
Copyright
Copyright © Cambridge University Press 1997

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1.Adams, M. E., McCall, N. T., Gray, D. T., et al. Economic analysis in randomized controlled trials. Medical Care, 1992, 30, 231–43.CrossRefGoogle Scholar
2.Canadian Coordinating Office for Health Technology Assessment. Guidelines for economic evaluation of Pharmaceuticals: Canada, 1st Ed., Ottawa: CCOHTA, 1994.Google Scholar
3.Cannon, C., McCabe, C. H., Henry, T. D., et al. A pilot trial of recombinant desulfatohirudin compared with heparin in conjunction with tissue plasminogen activator and aspirin for acute myocardial infarction: Results of the Thrombolysis in Myocardial Infarction (TIMI)-5 Trial. Journal of the American College of Cardiology, 1994, 23, 993–1003.CrossRefGoogle Scholar
4.Commonwealth of Australia. Guidelines for the pharmaceutical industry on preparation of submissions to the Pharmaceutical Benefits Advisory Committee: Including submissions involving economic analysis. Canberra: Department of Health, Housing and Community Services, 1992.Google Scholar
5.Drummond, M. F., & Davies, L. M.Economic analysis alongside clinical trials: Revisiting the methodological issues. International Journal of Technology Assessment in Health Care, 1991, 7, 561–73.CrossRefGoogle ScholarPubMed
6.Gold, M. R., Siegel, J. E., Russell, L. B., & Weinstein, M. C. (eds.). Cost-effectiveness in health and medicine. New York: Oxford University Press, 1996.CrossRefGoogle ScholarPubMed
7.Koopmanschap, M. A., Rutten, F. F. H., van Ineveld, B. M., & van Roijen, L.The friction cost method for measuring indirect costs of disease. Journal of Health Economics, 1995, 14, 171–89.CrossRefGoogle ScholarPubMed
8.Krumholz, H. M., Pasternak, R. C., Weinstein, M. C., et al. Cost effectiveness of thrombolytic therapy with streptokinase in elderly patients with acute myocardial infarction. New England Journal of Medicine, 1992, 327, 7–13.CrossRefGoogle Scholar
9.Lee, L. V., for the TIMI Investigators. Initial experience with hirudin in conjunction with streptokinase in acute myocardial infarction: Results of the Thrombolysis in Myocardial Infarction (TIMI)-6 Trial. American Journal of Cardiology, 1995, 75, 7–13.CrossRefGoogle Scholar
10.Levin, L.-Å., & Jönsson, B.Cost-effectiveness of thrombolysis: A randomized study of intravenous r-tPA in suspected myocardial infarction. European Heart Journal, 1992, 13, 2–8.CrossRefGoogle Scholar
11.Mark, D. B., and the GUSTO llb Investigators. Economic outcomes in GUSTO llb: Substudy protocol, Version 4.0. Durham, NC: Duke University Medical Center, 12 30, 1994.Google Scholar
12.Mark, D. B., Hlatky, M. A., Califf, R. M., et al. Cost effectiveness of thrombolytic therapy with tissue plasminogen activator as compared with streptokinase for acute myocardial infarction. New England Journal of Medicine, 1995, 332, 1418–24.CrossRefGoogle ScholarPubMed
13.Olsson, G., Levin, L-Å., & Rehnqvist, N.Economic consequences of postinfarction prophylaxis with beta blockers: Cost-effectiveness of metoprolol. British Medical Journal, 1987, 294, 339–42.CrossRefGoogle ScholarPubMed
14.Ontario Ministry of Health. Guidelinesfor preparation of economic analysis to be included in submission to Drug Programs Branch for listing in the Ontario Drug Benefit Formula Comparative Drug Index. Toronto: Ontario Ministry of Health, 1991.Google Scholar
15.Patrick, D. L., & Erickson, P.Health status and health policy: Allocating resources to health care. New York: Oxford University Press, 1993.Google Scholar
16.Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: The Scandinavian Simvastatin Survival Study. Lancet, 1995, 344, 1383–89.Google Scholar
17.Task Force on Principles for Economic Analysis of Health Care Technology. Economic analysis of health care technology: A report on principles. Annals of Internal Medicine, 1995, 122, 61–70.Google Scholar
18.Topol, E., Fuster, V., Harrington, R. A., et al. Recombinant hirudin for unstable anginapectoris. Circulation, 1994, 89, 1557–66.CrossRefGoogle Scholar
19.Van de Werf, F., Topol, E. J., Lee, K. L., et al. Variations in patient management and outcomes for acute myocardial infarction in the United States and other countries: Results from the GUSTO trial. Journal of the American Medical Association, 1995, 273, 1586–1591.CrossRefGoogle ScholarPubMed
20.Weinstein, M. C., & Stason, W. B.Cost-effectiveness of interventions to prevent or treat coronary heart disease. Annual Review of Public Health, 1985, 6, 41–63.CrossRefGoogle ScholarPubMed