American College of Cardiology

STEVENSON AND KORMOS, ET AL., Mechanical Carida Support 2000
JACC Vol. 37, No. 1, January 2001:340-70

Figures and Tables

Figure 1.

Line depicting the relationship between equipoise and efficacy of a new therapy, as perceived after initial clinical testing. It is possible that the early experience could be so dramatic that both the scientific and regulatory community regard it as a “breakthrough” therapy that should be approved without further investigation for the defined population. Initial experience could also demonstrate sufficient success that the scientific community is convinced of efficacy, while the regulatory agencies require further information. This gap might be bridged by continued clinical investigation at limited sites, with prospective definition of a non-randomized cohort for comparison. In the majority of cases, initial testing does not establish efficacy, and clinical equipoise can be maintained for the performance of randomized controlled trials. It is anticipated that patient preference regarding new therapies will most often lie to the right of clinical equipoise, complicating trials of therapies that cannot be blinded. The asymmetry of the line to the right of equipoise reflects the enthusiasm necessary to drive any therapy through clinical evaluation.

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