Trial-based clinical and economic analyses: the unhelpful quest for conformity

Stirling Bryan,David Gt Whitehurst

doi:10.1186/1745-6215-14-421

Abstract

Where there is conformity across the findings, interpretation and implications of 'clinical’ and 'economic’ research, there is limited cause for concern. However, there is often unease when apparent contradictory conclusions are drawn from the same study. Given the ever increasing role for economic evaluation in healthcare decision making, this commentary challenges the necessity of compatibility between clinical and economic evaluation.

Highlights

With many countries requiring evidence of cost-effectiveness prior to passing judgment on the value of a medical intervention, it is inevitable that clinical and economic evidence will be considered concurrently by policy makers [1,2]
A recent study reported that a lifestyle program for adults at risk for type 2 diabetes and/or cardiovascular disease was not more effective in reducing these risks when compared to general health brochures, the intervention had a high probability of being cost-effective [7]
Differing opinions regarding the role of economic evaluation alongside randomized controlled trials (RCTs) with indeterminate clinical findings can result in difficulties/delays in publishing economic evaluation results, irrespective of whether concerns are expressed within the study team or during the peer-review process

Summary

Background

With many countries requiring evidence of cost-effectiveness prior to passing judgment on the value of a medical intervention, it is inevitable that clinical and economic evidence will be considered concurrently by policy makers [1,2]. Guidelines for the conduct of economic evaluation alongside such trials state that acceptable differences in costs and effects must be defined a priori in order to explore non-inferior or equivalent cost-effectiveness of study treatments. These requirements take no account of the key analytic focus of economic evaluation: estimation of the joint density of cost and effect differences [11]. In a trial-based economic evaluation, irrespective of the clinical findings or RCT design (superiority, noninferiority, or equivalence), an analyst should focus on estimating cost and effect differences and quantifying the likelihood that an intervention is cost-effective [9,12]

Conclusions

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