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Should Clinical Trials With Concurrent Economic Analyses Be Blinded? FREE

Nick Freemantle, MA; Michael Drummond, DPhil
[+] Author Affiliations

Reprints: Nick Freemantle, MA, Centre for Health Economics, University of York, Heslington, York Y01 5DD, England (e-mail: nf2@york.ac.uk).


JAMA. 1997;277(1):63-64. doi:10.1001/jama.1997.03540250071034
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ECONOMIC ANALYSES are increasingly conducted alongside clinical trials, as the funders of research recognize that they require estimates of both the costs and benefits of health care interventions. In fact, many commissioning organizations will fund clinical trials only if they are designed to provide estimates of cost-effectiveness, and economic analyses are already being used to inform decisions on the reimbursement of pharmaceuticals in some health care systems.1 The addition of economic data collection and analysis to clinical trials raises a number of important methodological issues,2 including whether those clinical trials incorporating an economic analysis should be blinded.

Rationale for Blinding in Clinical Trials  Blinding physicians and patients to treatment allocation in clinical trials aims to reduce bias in estimates of treatment effect, since outcomes are often open to interpretation, and knowledge of the treatment regimen may affect patient or physician behavior. The impact of blinding on estimates of

REFERENCES

Freemantle N, Henry D, Maynard A, Torrance G.  Promoting cost-effective prescribing: Great Britain lags behind . BMJ . 1995;;310:955-956.
Drummond MF, Davis L.  Economic analysis alongside clinical trials: revisiting the methodological issues . Int J Technol Assess Health Care . 1991;;7:561-573.
Schulz KF, Chalmers I, Hayes RJ, Altman DG.  Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials . JAMA . 1995;;273:408-412.
Schwartz D, Lellouch J.  Explanatory and pragmatic attitudes in therapeutic trials . J Chronic Dis . 1967;;20:637-648.
Cook TD, Campbell DT. Quasi-Experimentation: Design and Analysis Issues for Field Settings . Chicago, Ill: Rand McNally; 1979;.
The GUSTO Investigators.  An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction . N Engl J Med . 1993;;329:673-682.
Mark DB, Hlatky MA, Califf RM, et al.  Cost-effectiveness of thrombolytic therapy with tissue plasminogen activator as compared with streptokinase for acute myocardial infarction . N Engl J Med . 1995;;332:1418-1424.
Van de Werf F, Topol EJ, Lee KL, et al.  Variations in patient management and outcomes for acute myocardial infarction in the United States and other countries: results from the GUSTO trial . JAMA . 1995;;273:1586-1591.
Simon GE, VonKorff M, Heilingenstein JH, et al.  Initial antidepressant choice in primary care: effectiveness and cost of fluoxetine vs tricyclic antidepressants . JAMA . 1996;;275:1897-1902.
Kramer PD. Listening to Prozac: A Psychiatrist Explores Antidepressant Drugs and the Remaking of the Self . London, England: Fourth Estate; 1994;.
 Sertraline for treatment of depression . Med Lett Drugs Ther . 1992;;34:47-48.
Freemantle N, Bloor K.  Lessons from international experience in controlling pharmaceutical expenditure, I: influencing patients . BMJ . 1996;;312:1469-1471.

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Freemantle N, Henry D, Maynard A, Torrance G.  Promoting cost-effective prescribing: Great Britain lags behind . BMJ . 1995;;310:955-956.
Drummond MF, Davis L.  Economic analysis alongside clinical trials: revisiting the methodological issues . Int J Technol Assess Health Care . 1991;;7:561-573.
Schulz KF, Chalmers I, Hayes RJ, Altman DG.  Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials . JAMA . 1995;;273:408-412.
Schwartz D, Lellouch J.  Explanatory and pragmatic attitudes in therapeutic trials . J Chronic Dis . 1967;;20:637-648.
Cook TD, Campbell DT. Quasi-Experimentation: Design and Analysis Issues for Field Settings . Chicago, Ill: Rand McNally; 1979;.
The GUSTO Investigators.  An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction . N Engl J Med . 1993;;329:673-682.
Mark DB, Hlatky MA, Califf RM, et al.  Cost-effectiveness of thrombolytic therapy with tissue plasminogen activator as compared with streptokinase for acute myocardial infarction . N Engl J Med . 1995;;332:1418-1424.
Van de Werf F, Topol EJ, Lee KL, et al.  Variations in patient management and outcomes for acute myocardial infarction in the United States and other countries: results from the GUSTO trial . JAMA . 1995;;273:1586-1591.
Simon GE, VonKorff M, Heilingenstein JH, et al.  Initial antidepressant choice in primary care: effectiveness and cost of fluoxetine vs tricyclic antidepressants . JAMA . 1996;;275:1897-1902.
Kramer PD. Listening to Prozac: A Psychiatrist Explores Antidepressant Drugs and the Remaking of the Self . London, England: Fourth Estate; 1994;.
 Sertraline for treatment of depression . Med Lett Drugs Ther . 1992;;34:47-48.
Freemantle N, Bloor K.  Lessons from international experience in controlling pharmaceutical expenditure, I: influencing patients . BMJ . 1996;;312:1469-1471.
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