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Trials and Tribulations: Emerging Issues in Designing Economic Evaluations Alongside Clinical Trials

Published online by Cambridge University Press:  10 March 2009

Douglas Coyle
Affiliation:
University of Ottawa
Linda Davies
Affiliation:
University of York
Michael F. Drummond
Affiliation:
University of York

Abstract

Decisions relating to designing and implementing economic evaluations alongside clinical trials are dependent on a number of issues. Initial consideration should focus on whether an economic evaluation is appropriate, whether a randomized controlled trial (RCT) is a suitable vehicle, and whether the design of the specific RCT is appropriate for integration of economic evaluation. If an economic evaluation is appropriate, decisions are required on how economic data are to be collected and analyzed. This paper discusses these and other issues and, where appropriate, provides recommendations for future studies.

Type
General Essays
Copyright
Copyright © Cambridge University Press 1998

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References

REFERENCES

1.Adams, M. E., McCall, N. T., Gray, D. T., et al. Economic analysis in randomized control trials. Medical Care, 1991, 30, 231–43.CrossRefGoogle Scholar
2.Bulpitt, C. J., & Fletcher, A. E.Economic assessments in randomized controlled trials. Medical Journal of Australia, 1990, 153(suppl.), s16–s19.CrossRefGoogle ScholarPubMed
3.Commonwealth of Australia. Guidelines for the pharmaceutical industry on preparation of submissions to the Pharmaceutical Benefits Advisory Committee, including submissions involving economic analyses. Canberra: Department of Health, Housing and CommunityServices, 1992.Google Scholar
4.Donaldson, C., Hundley, V., & Mclntosh, E.Using economics alongside clinical trials: Why we cannot choose the evaluation techniques in advance. Health Economics, 1996, 5, 267–69.3.0.CO;2-X>CrossRefGoogle ScholarPubMed
5.Drummond, M. F.Economic analysis alongside clinical trials: Problems and potential. Journal of Rheumatology, 1995, 22, 1403–07.Google ScholarPubMed
6.Drummond, M. F, Bloom, B. S., Carrin, G., et al. Issues in the cross national assessment of health technology. International Journal of Technology Assessment in Health Care 1992, 8, 671–82.CrossRefGoogle ScholarPubMed
7.Drummond, M. F., & Coyle, D.The role of pilot studies in the economic evaluation of health technologies. International Journal of Technology Assessment in Health Care, 1998, 14, in press.CrossRefGoogle ScholarPubMed
8.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
9.Eisenberg, J., Glick, H., Schulman, K., et al. Pharmacoeconomics: Economic evaluation of Pharmaceuticals. In Strom, B. (ed.), Pharmacoepidemiology, 2nd ed.Chichester: John Wiley and Sons Ltd, 1994, 469–93.Google Scholar
10.Ellwein, L. B., & Drummond, M. F.Economic analysis alongside clinical trials: Bias in the assessment of economic outcomes. International Journal of Technology Assessmen in Health Care, 1996, 12, 691–97.CrossRefGoogle ScholarPubMed
11.Gafni, A., & Birch, S.Guidelines for the adoption of new technologies: A prescription for uncontrolled growth in expenditures and how to avoid the problem. Canadian Medical Association Journal, 1993, 148, 913–17.Google ScholarPubMed
12.Glick, H.Strategies for economic assessment during the development of new drugs. Drug Information Journal, 1995, 29, 1391–403.CrossRefGoogle Scholar
13.Hillman, A. L., Eisenberg, J. M., Pauly, M. V., et al. Avoiding bias in the conduct and reporting of cost-effectiveness research sponsored by pharmaceutical companies. New England Journal of Medicine, 1991, 324, 1362–65.CrossRefGoogle ScholarPubMed
14.Laupacis, A., Feeny, D., Detsky, A. S., & Tugwell, P. X.How attractive does a new technology have to be to warrant adoption and utilization? Tentative guidelines for using clinical and economic evaluations. Canadian Medical Association Journal, 1992, 146, 473–81.Google ScholarPubMed
15.Mauskopf, J., Schulman, K., Bell, I., & Glick, H.A strategy for collecting pharmacoeconomic data during phase II/III clinical trials. Pharmacoeconomics, 1996, 9, 264–77.CrossRefGoogle ScholarPubMed
16.Menzin, J., Oster, G., Davies, L., et al. A multinational economic evaluation of rhDNase in the treatment of cystic fibrosis. International Journal of Technology Assessment in Health Care, 1996, 12, 5261.CrossRefGoogle ScholarPubMed
17.O'Brien, B.Economic evaluation of pharmaceuticals: Frankenstein’s monster or vampire of trials. Medical Care, 1996, 34, DS99–DS108.Google ScholarPubMed
18.O'Brien, B. J., Drummond, M. F., Labelle, R. J., & Willan, A.In search of power and significance: Issues in the design and analysis of stochastic cost-effectiveness studies in health care. Medical Care, 1994, 32, 150–63.CrossRefGoogle ScholarPubMed
19.Ontario Ministry of Health. Ontario guidelines for economic analyses of pharmaceutical products. Toronto: Ministry of Health, 1994.Google Scholar
20.van Hout, B. A., Al, M. J., Gordon, G. S., & Rutten, F. F. H.Costs, effects and C/E ratios alongside a clinical trial. Health Economics, 1994, 3, 309–19.CrossRefGoogle Scholar
21.Willan, A. R., & O'Brien, B. J.Confidence intervals for cost-effectiveness ratios in clinical trials: A new method using Fieller's theorem. Health Economics, 1996, 5, 297305.3.0.CO;2-T>CrossRefGoogle Scholar