Article,

Equipoise, design bias, and randomized controlled trials: the elusive ethics of new drug development.

, and .
Arthritis research & therapy, 6 (3): R250-5 (January 2004)3835<m:linebreak></m:linebreak>Mesures de contrast.
DOI: 10.1186/ar1170

Abstract

The concept of 'equipoise', or the 'uncertainty principle', has been represented as a central ethical principle, and holds that a subject may be enrolled in a randomized controlled trial (RCT) only if there is true uncertainty about which of the trial arms is most likely to benefit the patient. We sought to estimate the frequency with which equipoise conditions were met in industry-sponsored RCTs in rheumatology, to explore the reasons for any deviations from equipoise, to examine the concept of 'design bias', and to consider alternative ethical formulations that might improve subject safety and autonomy. We studied abstracts accepted for the…(more)

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