Commentary: Is Informed Consent as Ethical as it Could be?

Document Type

Article

Publication Date

3-17-2008

Publication Title

Bio-IT-World

Abstract

I would like to bring to the attention of readers of eCliniqua some of my thoughts about making the informed consent process more ethical (see refs. 1, 2, and 3). Many are aware, particularly in Phase III confirmatory proof of efficacy trials, that the determination of sample size carries with it an efficacy imperative. That is, in order to confirm a question regarding efficacy of a compound, it is imperative that the sample size of the trial be large enough to provide a priori a high probability (large power) that the question will be answered.

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