Improving Quality of Pharmacoeconomic Studies: Guidelines for Avoiding Bias

Ohishi Akira, Schulman Kevin A.

doi:10.4091/iken1991.8.1_25

Economic analysis of new medical therapies and new medical technologies is an increasingly important endeavor worldwide. Pharmacoeconomic research should be conducted not only by pharmaceutical companies but also by academic investigators. However, in the current environment, manufacturers are the sponsors of most economic evaluations of their products. This sponsorship can lead directly to the potential for conflicts of interest or bias in study design or results. However, this potential for bias can be managed by carefully defining the relationship between investigators and sponsors (investigator independence and independent publication rights), and by financial disclosure policies by journals. Further, the development of high-quality economic data from clinical trials removes many potential sources of bias that exist in the construction of economic models. In this paper, we introduced and reviewed several efforts to develop guidelines for conduct of economic studies to improve the quality of the economic literature: the New England Journal of Medicine's policy on cost-effectiveness analysis; the Task Force on Principles for Economic Analysis of Health Care Technology's voluntary ethical guidelines; and the FDA's draft guidelines that concern promotional claims and standards of evidence for comparative research which should be of interest to the Japanese audience. If it is to be useful for policy-makers, economic data must be credible and reliable. We must strive to create a system where manufacturers have an interest in unbiased assessment of their products to promote a truly competitive marketplace for pharmaceutical products.

Improving Quality of Pharmacoeconomic Studies: Guidelines for Avoiding Bias

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